Frequently Asked Questions

or

Applicants

Applicants with a Criminal History

Applicants with a criminal conviction(s) are not automatically denied a license as there is nothing in pharmacy law that requires the Board of Pharmacy to deny an application based on a specific conviction. In reviewing applications for licensure, the board will consider prior convictions of the applicant, however.

Effective July 1, 2020, the board’s authority to deny an application based on certain criminal convictions was restricted. (Business and Professions Code Section 480). Specifically, the board cannot deny an application on the basis of an application if:

NOTE: The preceding seven-year limitation shall not apply in either of the following situations:

  • The applicant was convicted of a serious felony, as defined in Section 1192.7 of the Penal Code,
  • The applicant was convicted of a crime for which registration is required pursuant to paragraph (2) or (3) of subdivision (d) of Section 290 of the Penal Code.

Unless restricted, the board may deny an application for licensure if the applicant was convicted of a crime substantially related to the qualifications, functions or duties of the pharmacy profession. In assessing whether crimes are substantially related to the profession, the board uses the criteria set out in a board regulation (California Code of Regulations, title 16, Section 1770). The board will review applicants with a criminal history on a case-by-case basis and will consider evidence of rehabilitation using the criteria set out in Section 1769(b) of the board’s regulations and the board’s Disciplinary Guidelines, which currently includes:

  • The nature and severity of the act(s) or offense(s).
  • Evidence of any act(s) committed subsequent to the act(s) or crimes.
  • The time that has elapsed since commission of the act(s) or crime(s).
  • Whether the applicant has complied with any terms of parole, probation, restitution, or any other sanctions lawfully imposed against the applicant.
  • Evidence, if any, of rehabilitation submitted by the applicant.

The board has proposed changes to both of these regulations to more specifically identify the criteria it uses. The proposed changes to these two regulations are on the board’s website at https://www.pharmacy.ca.gov/laws_regs/1769_1770_pt.pdf.

Revised August 2022

No. A determination regarding an applicant’s eligibility to obtain a license will not be made prior to the submission of an application. Consequently, board staff will not provide opinions about whether an applicant’s specific criminal history will result in the approval or denial of an application.

Revised August 2022

Yes. The board may have to request court documents to assess and ensure that a conviction was dismissed pursuant to Penal Code sections 1203.4, 1203.4a, 1203.42 or a comparable dismissal or expungement. If the board determines that a conviction was dismissed pursuant to one of these sections or a comparable dismissal or expungement, the board cannot use the conviction as the basis for denying a license to the applicant.

Applicants are not required to disclose any conviction or provide any documentation regarding any prior convictions. Applicants may voluntarily provide a certified certificate of rehabilitation or proof of dismissal with their application.

Revised August 2022

In order to be fair to all applicants, the board reviews each application in the order they are received. Applicants may, however, voluntarily provide the following documents to help expedite the review process. Providing the documents is completely voluntary and is not a factor in the board’s decision to approve or deny and application.

  • A written explanation detailing the circumstances surrounding each conviction.
  • A copy of the arrest/incident report(s) for each conviction.
  • A certified copy of the court documentation for each conviction. Court documentation submitted should include, but is not limited to, the criminal complaint, court minutes, sentencing, and probation order.
  • Current proof of compliance with probation may include, but is not limited to, participation in or completion of any drug and/or alcohol, anger management, domestic violence, or theft programs; payment of fees, fines or restitution; or completion of community service.
  • Additional evidence of mitigation including, but not limited to: letters of recommendation, proof of employment or volunteer work, completion or enrollment in school or training programs, etc.
  • A certified document showing the date an applicant was released from incarceration for a conviction, if any.

Revised August 2022

The board will notify applicants by mail if their application has been forwarded to the Criminal Conviction Unit for additional review. If an applicants’ address of record changed since the application was submitted, please submit a change of address request at https://pharmacy.ca.gov/about/change_of_address.shtml.

Revised August 2022

You may contact us for a status request if it has been at least 45 days since the date that the application was forwarded to the Criminal Conviction Unit and your license has not been issued.

Revised August 2022

No. The board cannot require an applicant for licensure to disclose any information or documentation regarding the applicant’s criminal history. However, the board may request mitigating information from an applicant regarding the applicant’s criminal history for purposes of determining substantial relationship or evidence of rehabilitation. The applicant’s decision not to disclose any information is not be a factor in the board’s decision to grant or deny an application for licensure.

Revised August 2022

Consumers

Filing a Complaint

The Board’s mission is to protect the health, safety, and welfare of Californians. This includes reviewing, evaluating, and resolving consumer complaints regarding licensees.

Complaints about pharmacist misconduct or prescription errors should be reported regardless of whether a patient is harmed. Other types of complaints are not within the Board’s jurisdiction – such as prescription drug prices, problems with over-the-counter medications, or insurance billing disputes. However, you may contact the Board for information about possible options to resolve your complaint.

Although the Board generally has no jurisdiction over drug prices, California law requires MediCal provider pharmacies to sell prescription drugs to Medicare recipients at Medi-Cal prices. You may file a complaint with the Board of Pharmacy if you believe a pharmacy is not charging you the correct price under this program.

The Board recommends comparing prices at several pharmacies to obtain the best prices for your drugs. Also, ask your doctor or pharmacist if a less expensive generic product is available.

The following are the most common complaints received that do NOT fall under the jurisdiction of the CA State Board of Pharmacy and the appropriate reporting agencies.

Type of complaint: Who to contact:
Assisted Living Facilities
Board and Care Facilities
CA Dept. of Social Services
www.cdss.ca.gov
(916) 651-8848
Billing Issues with Health Plan and other billing issues CA Dept. of Managed Healthcare
www.dmhc.ca.gov
888-466-2219
Customer Service Issues Corporate Offices/Business Owner/Yelp
Discrimination

U.S. Dept. of Health & Human Services
Office for Civil Rights
www.hhs.gov
800-368-1019

Disability CA Dept. of Justice, Disability Rights Bureau
www.oag.ca.gov/civil/disability-rights
916-504-5800
Over the Counter Medications (OTC) or Non-prescription Medications CA Dept. of Public Health – Food & Drug Branch
www.cdph.ca.gov
800-495-3232
Medicare CA Dept. of Health & Human Services
www.cms.gov
800-633-4227
Medi-Cal CA Dept. of Health Care Services
www.dhcs.ca.gov
888-452-8609
Health Care Facilities
Acute Care Hospitals
Skilled Nursing Facilities
Hospice Homecare
CA Dept. of Public Health
www.cdph.ca.gov
916-558-1784
Physicians Medical Board of CA
www.mbc.ca.gov
800-633-2322
Refunds CA Dept. of Justice
www.oag.ca.gov/consumers/general/refunds
916-210-6276
Federal Veterans Affairs
pharmacy/hospitals
U.S. Dept. of Veterans Affairs
www.va.gov
800-698-2411
California Dept of Veterans Affairs
Nursing facilities and Assisted Living Facilities
California Dept. of Veterans Affairs (CalVet)
www.calvet.ca.gov/contact
800-952-5626

You may refer to Business and Professions Code, Chapter 9, Sections 4057 for a detailed list of items not within Board of Pharmacy jurisdiction by clicking the Lawbook icon at the Board’s website, www.pharmacy.ca.gov.

The Board of Pharmacy’s jurisdiction includes dangerous drugs and dangerous devices described in Business and Professions Code, Chapter 9, Section 4006 and 4022.

Revised March 2026

Any action by a licensed pharmacy or pharmacist that appears improper should be reported to the Board. Examples of misconduct include:

The pharmacist fails to counsel you about how to take a new prescription (or a prescription with changed instructions) and possible side effects.

A non-pharmacist employee is allowed to counsel you regarding your prescription.

The pharmacist is not present, and your prescription is filled by a non-pharmacist.

The pharmacist fails to maintain the confidentiality of your prescription.

The pharmacist appears unable to function safely (due to alcohol or drug abuse).

The pharmacy appears dirty, cluttered, or unsanitary.

Revised March 2026

Examples of prescription errors include:

Incorrect information is entered on the label of the prescription container.

A prescription is dispensed with the wrong drug or wrong dosage.

A prescription is refilled without proper authorization from the prescribing physician.

A generic drug is substituted for a brand-name drug without informing the patient.

A prescription is filled with expired drugs.

Revised March 2026

You may submit a complaint online or download a complaint form at the Board’s website at www.pharmacy.ca.gov. (Forms are available in English and Spanish.) Mail the completed form to:

Board of Pharmacy
Attention: Complaint Unit 2720 Gateway Oaks Drive, Suite 100
Sacramento, CA 95833

To help the Board evaluate your complaint, provide as many details as possible. Include copies of any related documentation, such as prescriptions, invoices, or correspondence. If your complaint is about a dispensing error or a prescription container that is incorrectly labeled, keep the container and its contents for reference if possible.

Revised March 2026

The Board will notify you by letter when your complaint is received. After evaluating your complaint, the Board may advise the pharmacy of your concerns and ask for an explanation. In some instances, depending on the type of complaint, your name may be kept confidential.

The Board will take disciplinary action if its investigation reveals a violation of California pharmacy law. The action, based on the type and severity of violation, can range from an official warning and/or fine to suspension, probation, or revocation of license.

Revised March 2026

Yes. You will receive a written notice of the outcome and any action taken by the Board. Routine investigations may take about six months, while more complex cases requiring extensive investigation may take longer.

You also may write to the Board and request information regarding the complaint outcome. The Board will respond in writing with the following information:

The date the complaint was received.

A summary of the investigation.

The case outcome or type of discipline.

Formal disciplinary actions are matters of public record, as are licensee names, numbers, and addresses of record; original license date of issue; and current license status (active or inactive). You can check the license status of any pharmacy, pharmacist, or other business or person licensed by the Board of Pharmacy by clicking the License Search icon at the Board’s website, www.pharmacy.ca.gov.

Revised March 2026

Applicants

Becoming Licensed as a Pharmacist in California

The examination program will be comprised of two parts:

  1. Passing the North American Pharmacist Licensure Examination (or NAPLEX) which is prepared by the National Association of Boards of Pharmacy (NABP). For the score to be valid in California, this exam must be passed on or after January 1, 2004.
  2. Passing the California Pharmacist Jurisprudence Exam (CPJE). This exam is developed by the California State Board of Pharmacy. (Note: this exam is different than the Multistate Pharmacist Jurisprudence Examination Administered by NABP.)

Both of these examinations will be given via a computer, and will be available for qualified applicants to take the examination six days a week throughout the year.

The new exam structure replaces the board’s prior written examination that was given twice a year.

You will apply to the California Board of Pharmacy with the application posted at www.pharmacy.ca.gov. This is the first part in the application process where California will review your eligibility to take the pharmacist licensure examination. You are also required to apply through NABP for the NAPLEX.

The requirements to become eligible to take the licensure examination will remain the same. Specifically, to take the pharmacist licensure examination for California, you must:

  1. Be at least 18 years of age
  2. Be a graduate of a domestic school of pharmacy or be a graduate of a foreign school of pharmacy and have been certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC)
  3. Have completed at least 150 semester hours of collegiate credit, 90 of which must be from a school of pharmacy
  4. Have earned at least a baccalaureate degree in a course of study devoted to pharmacy
  5. Have 1,500 hours of approved pharmaceutical experience as a registered intern or one year of experience as a licensed pharmacist in another state.

California law does not allow for reciprocity. You are required, at least, to take and pass both the NAPLEX and CPJE.

Revised January 2010

Yes

Revised January 2010

No, the board must receive your transcripts with the degree posted before the board will confirm your eligibility to NABP (which qualifies you to take the NAPLEX for California).

Revised January 2010

Yes. The MPJE examination offered by the NABP is a separate examination required by some states for licensure. It is not a requirement for licensure in California. Rather, applicants must pass the CPJE in addition to the NAPLEX to become licensed in California.

Revised January 2010

Score transfers are completed by the NABP. Please visit its Web site https://nabp.pharmacy/ for the specific requirements.

Revised January 2010

The content outline posted on the board’s Web site is for the CPJE. There is no MPJE examination required for applicants to become licensed in California. Rather an individual must pass the NAPLEX examination and the CPJE on or after January 1, 2004.

Revised January 2010

The NAPLEX examination is developed and administered by the NAPB. The board is not aware of any changes being made to this examination.

Revised January 2010

You must submit an examination application to the California Board of Pharmacy and satisfy all of the requirements. You must also submit a “Registration Bulletin” with the NABP to take the NAPLEX.

Revised January 2010

You will need to retake the CPJE only.

Revised January 2010

The CPJE is required. This examination is different than the MPJE administered by the NABP.

Revised January 2010

You have a total of one time to take the CPJE and one time to take the NAPLEX.

Revised January 2010

Please see the detailed content outline posted on the board’s Web site. There are sample questions available in the CPJE Handbook. There are additional sample test questions on the board’s Web site.

Revised January 2010

Yes

Revised January 2010

You may do this by personal check, money order or cashier’s check made payable to the “Board of Pharmacy.” Do not send cash.

Revised January 2010

The NABP charges for the NAPLEX; this fee of $485 is paid directly to the NABP.

Revised January 2010

If you are applying within 2 years from your previous attempt, you may submit a retake application and fee, if required. If you are applying after 2 years from your previous attempt, you are required to submit a new application, supporting documents and fee, if required.

Revised January 2010

If you had Live Scan done for the board within the past year, please submit with your application a copy of your Live Scan receipt. If the Live Scan was done more than a year ago, you are required to have Live Scan redone and submit a copy of the new receipt with your application. The board is able to follow up with the Department of Justice based on the receipt. If you had your Live Scan done for another agency (for example, employment or volunteer) you will need to have Live Scan done again as the results cannot be shared between agencies. You need to obtain both a state and federal background check.

Revised January 2010

If you live outside of California, you can come to California and have Live Scan done. However, if you are outside of California, you cannot do Live Scan as other states’ Live Scan systems are not connected to California’s Live Scan system. Instead, submit your fingerprints on fingerprint cards. We strongly recommend that you have your fingerprints professionally rolled on two fingerprint cards provided by the Board of Pharmacy. You also will need to submit with the fingerprint cards a processing fee of $49 made payable to the “Board of Pharmacy.” You may request the fingerprint cards at www.pharmacy.ca.gov.

Revised January 2010

Yes, the board will accept a passing score on the NAPLEX provided the exam was passed on or after January 1, 2004.

Revised January 2010

No, you can’t use the ATT from another state to take the CPJE. You will be required to apply with the California board and meet all application requirements to take CPJE.

Revised January 2010

You need to use the candidate handbooks for this information. Both the NAPLEX and CPJE Handbooks are online at our Web site. Both exams will be available nationwide but at different test locations (different firms provide each exam).

Revised January 2010

Yes, you may send your application to the board as well as the application to NABP for NAPLEX once you meet the requirements to take the exams. The application to be submitted to the board may be downloaded at www.pharmacy.ca.gov. Information pertaining to the application for NAPLEX may be found at https://nabp.pharmacy/. The board does not mail out either application.

Revised January 2010

All foreign graduates must first apply to the board as a foreign graduate in order to be scheduled for an exam for California. A United States social security number is still required before a license can be issued.

Revised January 2010

Applicants

CPJE and NAPLEX Passing Score

Section 4200(a)(6) of the Business and Professions Code (BPC) defines that the Board may issue a pharmacist license to an applicant who meets the following:

CPJE

  • Has passed a version of the California Practice Standards and Jurisprudence Examination (CPJE) for Pharmacists that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure and the applicant meets either of the following requirements:

NAPLEX

  • Has passed the North American Pharmacist Licensure Examination (NAPLEX) on or after January 1, 2004, and holds an active pharmacist license in another state or territory of the United States.
  • OR

  • Has passed the North American Pharmacist Licensure Examination (NAPLEX) that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure.

Based on the changes to BPC section 4200, NAPLEX and CPJE results are evaluated each time an application is processed as well as at the time of licensure which may result in an applicant having to retake the CPJE and/or NAPLEX examination.

Please be advised the timeframe of an occupational analysis is approximately five years pursuant to BPC section 4200.3.

The current occupational analysis for CPJE went into effect 6/1/2022.

The current occupational analysis for the NAPLEX went into effect 5/1/2025.

Yes, you will be required to retake the NAPLEX because you do not fall under the provisions of holding an active pharmacist license in another state and your passing NAPLEX score was outside the current occupational analysis.

Revised June 2025

You must hold a current active pharmacist license in another state for the Board to accept your passing NAPLEX score, if passed on or after January 1, 2004, pursuant to BPC 4200(a)(6)(A).

Revised June 2025

Yes, you are required to retake the CPJE because your passing CPJE score is outside of the current occupational analysis for the CPJE.

Revised June 2025

Consumers

Why should I talk to my pharmacist?

California pharmacy regulations require pharmacies to maintain patient medication profiles and counsel patients regarding their prescription medication before dispensing. Consultation provides the pharmacist with the opportunity to educate patients who present new prescriptions and protect them from potential problems associated with a new medication by discussing possible side effects, contraindications and the importance of following directions. Consultation also provides the pharmacist one more opportunity to prevent dispensing errors by inspecting the medication container's contents to assure that the proper drug is dispensed.

The pharmacist is required to talk to you about all new prescription medications that have not been provided to you before. You should know the answers to at least the following questions before taking prescription medications:

  1. What is the name of the medicine and what is it supposed to do?
  2. How and when do I take it and for how long?
  3. What do I do if I forget to take my medicine?
  4. Are there any side effects, and what do I do if they occur?
  5. Is there any written information available about the medicine?

Yes, a pharmacist in his or her professional judgment may refuse to fill a prescription.

No, the pharmacy is not required by law to take back prescriptions that have been dispensed.

California law places strict requirements on what information can be released. In most cases, the patient must approve release of any personal medical information.

California law requires 4 elements on the label be in 12-point san serif font and occupy at least 50% of the label.  These elements include:

  1. Name of the patient;
  2. Name of the drug and strength of the drug – name can mean a manufacturer’s trade name or the generic name with the name of the manufacturer;
  3. The directions for use of the drug; and,
  4. The condition or purpose for the drug being prescribed if it was indicated on the prescription.

You may file a complaint with the board. The board will research the issue and let you know if pharmacy law was violated. Information on filing a complaint can be found here.

Yes. You have a right to interpreter services at your request with no cost to you.

The pharmacy is required to have an 8 ½ x 11 paper that says “Point to your language. Interpreter services will be provided to you upon request at no cost.” in the following languages: Arabic, Armenian, Cambodian, Cantonese, Farsi, Hmong, Korean, Mandarin, Russian, Spanish, Tagalog, and Vietnamese.

Effective 1/1/16, pharmacists have access to already translated directions for use in 5 languages from the board’s website: Chinese, Korean, Russian, Spanish and Vietnamese.

  1. What is the name of the medicine and what is it supposed to do?
  2. How and when do I take it and for how long?
  3. What do I do if I forget to take my medicine?
  4. Are there any side effects, and what do I do if they occur?
  5. Is there any written information available about the medicine?

If you are not getting pain relief or are having side effects that you cannot tolerate, call your doctor or pharmacist.

It is better to take your pain medication on a schedule if you are having constant pain. Do not wait until the pain is severe before taking your pain medication.

  1. Stopping too soon.
  2. Taking too little.
  3. Taking too much.
  4. Refusing to take the medicine.
  • What condition the medicine is for, and what it is supposed to do;
  • How much to give;
  • If there are any side effects and what to do if they occur; and
  • What to do if a dose is missed.

Licensees

Automated Drug Delivery System (ADDS)

Section 1: Licensing

BPC section 4017.3(b) defines an “automated unit dose system” (AUDS) as an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. BPC sections 4427.3 and 4427.65 provide the permissible locations at which AUDS can be located. These include a facility licensed by the State of California to provide pharmaceutical services. The exemptions from licensure of an ADDS are contained in BPC section 4427.2. Section 4427.2(i) exempts from licensure an AUDS operated by a licensed hospital pharmacy, as defined in BPC section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility, as defined in subdivision (a) of section 1250 of the Health and Safety Code, to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (b) of section 1250 of the Health and Safety Code, or dispensed to patients pursuant to BPC section 4068 if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and devices in the AUDS. A psychiatric health facility does not meet the requirements for licensure exemption unless it is a licensed acute psychiatric hospital facility as detailed in section 4427.2(i). If a psychiatric health facility does not meet the licensure exemption criteria in BPC section 4427.2(i), it may use an AUDS, but that AUDS must be licensed with the Board, and it must follow all the other requirements for an ADDS.

NOTE: A psychiatric health facility, as defined in Health and Safety Code § 1250.2, is required to provide pharmaceutical services pursuant to Welfare and Institutions Code § 4080(e)(1)(J).

[Reference: Business and Professions Code (BPC) sections 4017.3, 4029, 4427.2 and 4427.65, Welfare and Institutions Code section 4080(e)(1)(J), Health and Safety Code sections 1250(a), 1250(b), 1250.2.]

Revised April 2026

Yes. BPC sections 4427.3 and 4427.65(a)(2) provide that an AUDS can be located and operated in a jail, youth detention facility, or other correctional facility where drugs are administered within the facility under the authority of the medical director. However, the exemptions from the licensure requirements for an ADDS are contained in BPC section 4427.2(i) and AUDS in youth facilities are not exempt from licensure.

[Reference: BPC sections 4427.2(i), 4427.3, 4427.65(a)(2).]

Revised April 2026

No, the drug room is not exempt from licensing the ADDS under the circumstances described. The drug room would only be exempt from the ADDS licensing requirement if the drugs in the ADDS are used solely to provide doses administered to patients while in the licensed general acute care hospital. When drugs from the ADDS are used for dispensing under the provisions of BPC section 4056, not solely for administration, the exemption no longer applies.

[Reference: BPC sections 4427.2(i), 4056]

Revised April 2026

The ADDS device cannot be used until the Board issues the ADDS permit.

[Reference: BPC sections 4427.1, 4427.2(a), 4119.11(a)(1), 4119.01(a)]

Revised April 2026

BPC section 4427.2(i) provides an exemption from licensure for an AUDS that is used to dispense dangerous drugs to emergency room patients pursuant to BPC section 4068. Section 4068(a) authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the hospital pharmacy is closed and there is no pharmacist available in the hospital, and that the quantity of drugs dispensed is limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply. Section 4068(b) additionally authorizes a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge if certain conditions are satisfied, including that the drug is not a controlled substance, that the drug was administered from single patient use multidose packaging and can be self-administered by the patient, and that dispensing the unused portion of the drug is required to continue treatment of the patient. The AUDS must comply with all other requirements for an ADDS set forth in Article 25 of the Pharmacy Law.

[Reference: BPC sections 4017.3, 4068, 4427.2(i)]

Revised April 2026

Once the application is approved, an email will be sent to the pharmacist-in-charge (PIC). The email will notify the pharmacy the application was approved and will include the ADDS license number, type of ADDS, the primary pharmacy license, the status, the name and address of the ADDS location, and expiration date. The Board requests that you print and attach a copy of the email to the location of the ADDS and replace it with the license when the physical license is received. Allow 4 to 6 weeks to receive the physical license in the mail at the pharmacy.

NOTE: To inquire about the status of your ADDS application, please email ADDS@dca.ca.gov.

Revised April 2026

No. An ADDS license is not required for technology, installed within the secured licensed premises area of a pharmacy, used in the selecting, counting, packaging, and labeling of dangerous drugs.

[Reference: BPC section 4427.2(j)]

Revised April 2026

No. An automated unit dose system (AUDS) operated by a licensed hospital pharmacy, as defined in BPC section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility, as defined in subdivision (a) of section 1250 of the Health and Safety Code, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (b) of section 1250 of the Health and Safety Code, is exempt from the requirement of obtaining an ADDS license if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. The licensed hospital pharmacy shall maintain a list of the locations of each AUDS it operates and shall make the list available to the Board upon request. In addition, the AUDS must comply with all other requirements for an ADDS set forth in Article 25 of the Pharmacy Law.

[Reference: BPC sections 4017.3 and 4427.2(i), Health and Safety Code sections 1250(a) and 1250(b)]

Revised April 2026

Section 2 Medication Error Reporting

Yes, per 16 CCR section 1711(f), any quality assurance record related to the use of a licensed automated drug delivery system must be submitted to the Board within 30 days of completion of the quality assurance review. For purposes of section 1711, a “medication error” means any variation from a prescription or drug order not authorized by the prescriber, as described in CCR section 1716, but does not include any variation that is corrected prior to furnishing the drug to the patient or the patient’s agent or any variation allowed by law.

[References: 16 CCR sections 1711 and 1716]

Revised April 2026

Any facility with an unlicensed ADDS must report the quality assurance review to the Board at the time of annual renewal of the facility license.

Pursuant to Health and Safety Code section 1261.6 (g) if the ADDS utilizes removable pockets, cards, drawers, or similar technology, or unit of use, or single dose containers, and the facility, in conjunction with the pharmacy, has developed policies and procedures to ensure the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the ADDS, then the facility and contracted personnel authorized by law to administer drugs may also restock the ADDS.

[Reference: CCR section 1711]

Revised April 2026

16 CCR section 1711(e) states that a record of the quality assurance review shall contain at least the following:

  1. The date, location, and participants in the quality assurance review;
  2. The pertinent data and other information relating to the medication error(s) reviewed and documentation of any patient contact required by subdivision (c) of section 1711;
  3. The findings and determinations generated by the quality assurance review; and
  4. Recommended changes to pharmacy policy, procedure, systems, or processes, if any.

[References: 16 CCR section 1711]

Revised April 2026

Pharmacies with a licensed ADDS may submit their ADDS-related quality assurance records either: 1) by mail to the address of the California State Board of Pharmacy at 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833; or 2) by email to ADDS@dca.ca.gov.

Any facility with an unlicensed ADDS must report the quality assurance review to the Board at the time of annual renewal of the facility license. Such reports may be submitted via email to ADDS@dca.ca.gov or included with the renewal application.

[Reference: 16 CCR section 1711(f).]

Revised April 2026

16 CCR section 1711(b) specifies that for purposes of section 1711, “medication error” does not include any variation that is corrected prior to furnishing the drug to the patient or patient’s agent. Accordingly, if the error is corrected prior to furnishing the drug to the patient or patient’s agent, this would not be considered a “medication error” for purposes of 16 CCR section 1711 and no report under section 1711(f) would be required.

[Reference: CCR section 1711]

Revised April 2026

Section 3 Automated Patient Dispensing System (APDS)

Drugs may only be dispensed from an APDS directly to a patient if certain specific requirements are met. Among other requirements, an APDS shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescription drugs and devices from an APDS and the APDS must have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.

All prescribed drugs and devices dispensed to a patient from an APDS for the first time must be accompanied by a consultation conducted by a pharmacist licensed by the Board via a telecommunications link that has two-way audio and video. Further, the pharmacy must be able to provide an immediate consultation with a pharmacist, either in person or via telephone, upon the request of the patient.

[Reference: BPC sections 4119.11(d) and 4427.6(f); 16 CCR section 1713]

Revised April 2026

No, all prescribed drugs and devices dispensed from the APDS for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the Board via a telecommunications link that has two-way audio and video.

[Reference: BPC sections 4119.11(d)(6) and 4427.6(f); 16 CCR section 1713]

Revised April 2026

A pharmacist licensed by the board shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.

[Reference: BPC sections 4119.11(d)(4) and 4427.6(d)]

Revised April 2026

The pharmacy shall develop, implement, and annually review written policies and procedures with respect to determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.

[Reference: BPC sections 4119.11(d)(1)(B) and 4427.6(a)(2); 16 CCR section 1713]

The pharmacy must develop, implement, and annually review written policies and procedures orienting participating patients on the use of the APDS, notifying patients when expected prescription medications are not available in the APDS, ensuring that patient use of the APDS does not interfere with delivery of drugs and devices, and ensuring delivery of drugs and devices to patients expecting to receive them from the APDS in the event the APDS is disabled or malfunctions.

[Reference: BPC sections 4119.11(d)(1) and 4427.6(a); 16 CCR section 1713]

Revised April 2026

Yes. Business and Professions Code section 4427.6 provides that an APDS must meet certain specific requirements. One of these requirements is that if an APDS is located and operated in a medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, the APDS is only used to dispense dangerous drugs and dangerous devices to patients of the practice.

[Reference: BPC sections 4427.6(j) and 4119.11]

Revised April 2026

Section 4 Miscellaneous

Per BPC section 4427.4(f), if drugs are not immediately transferred into an ADDs upon arrival at the ADDS location, the drugs may be stored for no longer than 48 hours in a secured room within the ADDS location. Upon retrieval of these drugs from secured storage, an inventory must be taken to detect any losses or overages.

[Reference: BPC section 4427.4]

Revised April 2026

Facilities using automated drug delivery system with an open-matrix design shall contact the California Department of Public Health for a clear understanding of the requirements for such use.

[Reference: Health and Safety Code section 1261.6]

Revised April 2026

Pharmacies should consult the federal regulations to ensure compliance with DEA requirements and contact the DEA for any necessary clarifications regarding federal rules regarding controlled substances. Cited below are some authorities from the DEA regarding ADDS.

[Reference: Code of Federal Regulations (CFR), title 21, section 1301.27, Pharmacist’s Manual DEA]

Revised April 2026

Licensees

Medication Error Reporting

A community pharmacy licensed pursuant to Article 7 of Chapter 9 of Division 2 of the Business and Professions Code (BPC) is required to report medication errors under AB 1286. For purposes of the measure, the term “community pharmacy” includes any pharmacy that dispenses medication to an outpatient, including both resident and nonresident pharmacies, but not including facilities of the California Department of Corrections and Rehabilitation.

[Reference: BPC 4113.1(a) and (c)]

Revised November 2025

For purposes of AB 1286 reporting, the term “medication error” includes any variation from a prescription drug order not authorized by the prescriber, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong directions, the wrong preparation, or the wrong route of administration, but does not include any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law.

[Reference: BPC 4113.1(d)]

Revised November 2025

The Board approved the Institute for Safe Medication Practices (ISMP) as the entity to receive medication error reports from community pharmacies under BPC 4113.1.

[Reference: BPC 4113.1(a) and (b)]

Revised November 2025

The Board has announced that medication errors occurring on or after September 1, 2025, must be reported under BPC 4113.1. The Board will use a variety of means to communicate any further updates to the implementation timeframe for BPC 4113.1 medication error reporting, including through the Board’s subscriber alert system and posting information on the California Medication Error Reporting (CAMER) page on its website.

Revised November 2025

A link to the ISMP registration portal can be found on the California Medication Error Reporting (CAMER) page on the Board’s website.

Revised November 2025

Per the contract between the Board and ISMP, ISMP will charge community pharmacies an initial registration fee of $70 for the first contract year, and a renewal fee of $47 per year for the second and third contract years.

Revised November 2025

It depends. AB 1286 generally requires a community pharmacy licensed by the Board to report, either directly or through a designated third party, all medication errors to an entity approved by the Board; however, subdivision (e) of BPC 4113.1 establishes a limited exemption from the reporting requirements, and specifies that an outpatient hospital pharmacy shall not be required to report a medication error that meets the requirements of an adverse event that has been reported to the State Department of Public Health pursuant to HSC 1279.1.

Revised November 2025

No, it is the policy of the Board that if the hospital pharmacy dispensing volume to outpatients is within the limit set forth in California Code of Regulations, title 16, section 1710, the pharmacy is not required to report medication errors through the CAMER program. It is anticipated that the Board will pursue a regulatory change to document this policy.

Revised November 2025

See questions #1, 7, and 8. If an infusion center pharmacy dispenses1 drugs to outpatients for administration2, and neither of the exemptions discussed in #7 or 8 apply, the pharmacy is required to report medication errors to CAMER.

Revised April 2026

If the facility meets the definition of a “community pharmacy” under BPC section 4113.1, the facility is required to report medication errors through the CAMER program. It is the responsibility of the pharmacist-in-charge to determine whether the facility is a “community pharmacy” as defined by BPC section 4113.1.

[Reference: BPC 4113.1]

Revised November 2025

Yes. The Board’s quality assurance regulations remain in place and pharmacies are still required to comply with those regulations.

[Reference: 16 CCR 1711]

Revised November 2025

Subdivision (f) of BPC 4113.1 (which was added by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), and which becomes effective on January 1, 2026) states that a pharmacy licensed pursuant to BPC 4112 shall only be required to report medication errors related to prescriptions dispensed to California residents.

[Reference: Stats. 2025, Ch. 196, Sec. 34 (AB 1503), effective January 1, 2026]

Revised November 2025

Licensees

Minimum Staffing Provisions

Effective January 1, 2024, a chain community pharmacy subject to BPC 4113.5 is required to be staffed at all times during normal business hours (defined as 8:00 am to 7:00 pm) with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services, unless any of the following conditions apply:

  • The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
  • The pharmacy is open beyond normal business hours, which is before 8:00 am and after 7:00 pm, in which case the minimum staffing requirement does not apply during the hours before 8:00 am and after 7:00 pm.
  • The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, CLIA-waived tests, or any other ancillary services provided by law, this exemption does not apply.

In addition, where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message.

Note: Additional minimum staffing requirements are detailed under “Pharmacy Technician Expanded Duties” below.

[Reference: BPC 4113.6]

Revised November 2025

AB 1286 is silent about the impact to the minimum staff requirement when interns are present. As stated in the prior question, a pharmacist on duty may waive the BPC 4113.6(a) minimum staffing requirement during specified hours based on workload need.

[Reference: BPC 4113.6(a)]

Revised November 2025

Licensees

Revisions to Inventory Reconciliation

The revisions to California Code of Regulations (CCR), Title 16, section 1715.65, Inventory Reconciliation Reports of Controlled Substances took effect January 1, 2023.

Below are questions frequently asked regarding the revisions to CCR §1715.65.

General

Effective January 1, 2023, every pharmacy and every clinic licensed under Business and Professions Code (BPC) §§ 4180 and 4190 must conduct inventory activities and prepare inventory reconciliation reports on the following ongoing basis:

  • All federal Schedule II controlled substances, at least once every three months;
  • For products containing the following substances in the following strengths per tablet, capsule, other unit, or specified volume, at least once every 12 months, the following controlled substances: alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product;
  • For any controlled substances not listed above, an inventory reconciliation report must also be prepared when a controlled substance loss is identified, no later than three months after discovery of the reportable loss of the controlled substance in addition to the timely report of the loss as required;
  • For any controlled substance not listed above, inventory activities must be performed at least once every two years from the performance of the last inventory activities.

CCR §§1715.65(a)(1), (a)(2), (a)(3)

However, if you are an inpatient hospital pharmacy, the inventory reconciliation for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product, must be performed quarterly. CCR §1715.65(a)(1), (a)(2), (a)(3)

Revised November 2023

Yes. When a controlled substance loss is identified, an inventory reconciliation report must be completed. The audit period must cover the period from the last physical count of the controlled substance before the loss was discovered through the date of discovery.

CCR §1715.65(a)(3)(A)

Losses of controlled substances must be reported no later than 30 days after the date of discovery in accordance with CCR 1715.6. If the cause of the losses is related to theft, diversion, or self-use the loss must be reported to the board within 14 days of discovery.

Controlled substance losses can be submitted online or mailed to the address of the board. CCR §1715.65(d), CCR §1715.6, BPC §4104(c)

Revised November 2023

An inventory reconciliation report must include the following:

  • A physical count, not an estimate, of all quantities of each federal controlled substance covered by the report that the pharmacy or clinic licensed by the board has in inventory, pursuant to BPC §§ 4180 or 4190. If an inpatient hospital pharmacy or licensed correctional pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.
  • The individual(s) who performed the inventory must sign and date the inventory or the report.
  • A review of all acquisitions and disposition of each federal controlled substance covered by the report since the last inventory reconciliation report covering that controlled substance.
  • A comparison of the physical counts in inventory to all acquisitions and dispositions (since the last inventory reconciliation report) of each federal controlled substance covered by the report.
  • Identification of all records used to compile the report, which must be maintained in the pharmacy or clinic.
  • The identification of each individual involved in preparing the report.
  • The possible causes of overages.
  • Identify to the Board, in writing, the losses and known causes. Reportable losses defined in CCR §1715.6, must be reported to the board within 30 days of discovery, unless the cause of the loss is theft, diversion, or self-use in which case the board must be notified within 14 days of discovery.
  • The inventory reconciliation report must be dated and signed by the PIC or the professional director of the clinic licensed pursuant to BPC §§4180 or 4190.
  • The report and all records used to compile the report must be readily retrievable in the pharmacy or clinic for three years.

CCR §1715.65(c), (d), (e)

Revised November 2023

“Inventory activities” are required for each controlled substances that is not already required to be physically counted quarterly or at least every twelve months. Inventory activities for these controlled substances must be performed at least once every two years from the performance of the last inventory activities. “Inventory activities” means inventory and all other functions sufficient to identify loss of controlled substances. The functions that are sufficient to identify loss outside of the inventory reconciliation process must be identified within the pharmacy’s policies and procedures.

CCR §1715.65(a)(1), (a)(2), (a)(3)(B)

Revised November 2023

Yes. Any individual involved in preparing the report must be identified in the report. Any individuals who perform the physical count of each federal scheduled controlled substance must sign and date the inventory or the report.

“Inventory activities” are required for each controlled substances that is not already required to be physically counted quarterly or at least every twelve months. Inventory activities for these controlled substances must be performed at least once every two years from the performance of the last inventory activities. “Inventory activities” means inventory and all other functions sufficient to identify loss of controlled substances. The functions that are sufficient to identify loss outside of the inventory reconciliation process must be identified within the pharmacy’s policies and procedures.

The pharmacist-in-charge of a pharmacy or the consulting pharmacist for a clinic licensed by the board pursuant to BPC §§ 4180 or 4190, must review all inventory activities performed and inventory reconciliation reports prepared and establish and maintain secure methods to prevent losses of federal controlled substances, including written policies and procedures for performing the inventory activities and preparing the inventory reconciliation reports.

In addition, the inventory reconciliation report must be dated and signed by the pharmacist-in-charge or the professional director for a clinic licensed by the board pursuant to BPC §§ 4180 or 4190. An individual may use a digital or electronic signature or biometric identifier in lieu of a physical signature for this report if, in addition, the individual physically signs a printed statement confirming the accuracy of the inventory or report. The signature must be dated, and the signed and dated statement must be retained on file in the pharmacy or clinic for three years.

CCR §§1715.65(b), (e)(1), (e)(2)

Revised November 2023

All inventory reconciliation reports, and all records used to compile the reports, are required to be readily retrievable in the pharmacy or clinic for three years.

CCR §1715.65(e)(2)

Revised November 2023

As a new PIC of a pharmacy, the PIC must complete an inventory reconciliation report for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg/10mg/5mls drug product within 30 days of becoming the PIC.

CCR §1715.65(f)

Revised November 2023

Whenever possible, the outgoing PIC should complete an inventory reconciliation report for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg/10mg/5mls drug product.

CCR §1715.65(f)

Whenever possible, it is also recommended (though not required) the outgoing PIC perform an inventory count of all controlled substances prior to their disassociation as the PIC.

Revised November 2023

Hospital Pharmacies and Drug Rooms

Yes. Under 22 CCR §70263(a), hospitals having fewer than 100 licensed beds (informally referred to as drug rooms) are required to have a license pursuant to BPC 4029 and 4056, and must comply with CCR §1715.65.

Revised November 2023

Yes. The hospital pharmacy must account for all controlled substances subjected to inventory reconciliation stored inside the licensed pharmacy premise and stored in all the ADDS throughout the hospital, including locations listed on the general acute care hospital license, provided the ADDS were stocked by the hospital pharmacy.

However, if any inpatient hospital pharmacy, or licensed correctional pharmacy, uses an ADDS, only the inventory in the ADDS may be accounted for by using a means other than a physical count.

CCR §1715.65(h)

Revised November 2023

Yes. The inventory reconciliation reports for an inpatient hospital pharmacy must include controlled substances stored within the pharmacy, within each pharmacy satellite location, and within each drug storage area in the hospital under the pharmacy’s control. A physical count of the controlled substances (all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product) is required. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.

CCR §§1715.65(a), (g), (h)

Revised November 2023

No. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.

CCR §1715.65(h)

Revised November 2023

It depends. Yes, the inpatient hospital pharmacy may use the ADDS audit report programs. However, when using these audit programs, the board recommends the pharmacy should also consider the following:

  • A review of the records of acquisition for the controlled substances being audited.
  • A review of the records of disposition for the controlled substances being audited, include expired drugs removed, drugs removed due to breakage, etc.
  • Review of discrepancy reports and adjustments made for shortages and overages, including all discrepancy reports opened and closed, and unaccounted-for losses.
  • The total loss of each controlled substance during the audit period, resulting from shortages, especially when the count is adjusted. If the total loss causes the aggregated amount to equal or exceed the thresholds listed in CCR §1715.6, the losses must be reported to the board.
  • All shortages were investigated to determine the cause.
  • When there is a shortage, the policies and procedures were reviewed to determine if any changes were needed to prevent the shortage from reoccurring.

CCR §§1715.65(b), (c), (h), 1715.6

Revised November 2023

Clinics licensed pursuant to BPC 4180 and 4190

No. The surgical clinic is required to take a physical count, not an estimate, of all quantities of each federal controlled substance covered by the inventory reconciliation report. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.

CCR §§1715.65(c)(1), (h)

Revised November 2023

No. If the controlled substance in the ADDS is stocked by the inpatient hospital pharmacy, the controlled substances in the ADDS will need to be included in the inpatient hospital pharmacy inventory reconciliation report.

CCR §1715.65(a)

Revised November 2023

No. ASC who are not licensed by the board are not required to comply with CCR §1715.65, since it is not licensed as a pharmacy nor a clinic with the board. The controlled substance acquired for the ASC would be acquired by the licensed prescriber authorized to purchase controlled substances.

BPC §§4170, 4059(b)

Revised November 2023

Yes. CCR §1715.65 does not specify who is required to perform the physical count. However, any individual who performs the required inventory must be authorized to access controlled substances and sign and date the inventory or inventory reconciliation report.

CCR §§1715.65(c)(1), (e)(1)

Revised November 2023

Yes. Every clinic licensed with the board must perform periodic inventory activities and prepare inventory reconciliation reports.

CCR § 1715.65(a)

Revised November 2023

Correctional Clinics – BPC §4187

No. If the correctional clinic, operated by the California Department of Corrections and Rehabilitation, uses an ADDS to stock the controlled substances, the controlled substance inventory in the ADDS may be accounted by using a means other than a physical count.

CCR §1715.65(h)

Revised November 2023

Yes. A county jail is operated by the county where it is located and not by the California Department of Corrections and Rehabilitation. Therefore, every pharmacy licensed with the board must perform periodic inventory activities and prepare inventory reconciliation reports.

CCR § 1715.65(a)

Revised November 2023

Compounding Pharmacies

No. The board recommends that when the pharmacy receives a new bottle of a powder for a federal Schedule II controlled substance and when a physical count is required for the inventory reconciliation, the pharmacy records the weight of the bottle with the powder remaining in the bottle.

CCR §1715.65(c)(1)

Revised November 2023

Long Term Care (LTC) Pharmacies

Yes. A physical count is required.

CCR §1715.65(c)(1)

Revised November 2023

Yes. Only inpatient hospital pharmacies and licensed correctional pharmacies that uses an ADDS may account for the inventory in the ADDS using means other than a physical count.

CCR §§1715.65(c)(1), (h)

Revised November 2023

Licensees

Staffing Decisions

AB 1286 amended BPC section 4113 to explicitly provide that the PIC “may” make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely. Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025) further amended section 4113 to state that the PIC “shall” (instead of “may”) make staffing decisions. This change becomes effective on January 1, 2026. The Board recommends that the PIC document their efforts to ensure sufficient staff are present.

Note: These provisions do not apply to facilities of the Department of Corrections and Rehabilitation.

[Reference: BPC 4113(c)(2); see also Stats. 2025, Ch. 196, Sec. 33 (AB 1503), effective January 1, 2026]

Revised November 2025

Effective January 1, 2024, if the PIC is not available, a pharmacist on duty may adjust staffing according to workload if needed. The Board recommends that the pharmacist on duty document their efforts to adjust staffing.

Note: These provisions do not apply to facilities of the Department of Corrections and Rehabilitation.

[Reference: BPC 4113(c)(2)]

Revised November 2025

Licensees

Unsafe Pharmacy Conditions

AB 1286 added new subdivision (d) to BPC section 4113, pursuant to which the pharmacist-in-charge or pharmacist on duty is required to immediately notify store management of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025) further amended subdivision (d) to state that the PIC or pharmacist on duty shall immediately notify store management “or the building owner or a similar entity” of any such conditions. This change becomes effective on January 1, 2026.

Conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff may include, but are not limited to, any of the following:

  • Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
  • Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions.
  • Vermin infestation that poses a risk to the safety or efficacy of medicine.

The Board recommends that the PIC or pharmacist on duty document any such notification made by them to store management or the building owner or a similar entity. The Board also recommends that pharmacies establish policies and procedures for the notification process to ensure reporting personnel and store management (or the building owner or a similar entity) have a common understanding of the process to be used.

[Reference: BPC 4113(d); see also Stats. 2025, Ch. 196, Sec. 33 (AB 1503), effective January 1, 2026]

Revised November 2025

Yes. Effective January 1, 2024, store management is required to take immediate and reasonable steps to address and resolve the conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. The pharmacy owner may also close a pharmacy to mitigate against a perceived immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.

[Reference: BPC 4113(d)]

Revised November 2025

Effective January 1, 2024, the law states that if the conditions are not resolved within 24 hours, the PIC or pharmacist on duty shall ensure the Board is timely notified.

[Reference: BPC 4113(d)]

Revised November 2025

The Board has established a dedicated email for such reporting: PharmacyAlert@dca.ca.gov. The Board requests that the following information be provided with the notification:

  • Name and license number of pharmacy,
  • Name and contact information for reporting party,
  • Name and contact information for store management that received the initial notification,
  • Copy of the notification provided to store management,
  • Documentation of the conditions including photographs, temperature logs, etc.

[Reference: BPC 4113(d)]

Revised November 2025

No, facilities of the Department of Corrections and Rehabilitation are exempt from these requirements.

[Reference: BPC 4113(d)(6)]

Revised November 2025

Licensees

Pharmaceutical and Sharps Waste Stewardship Programs

Senate Bill 212 (Jackson, Chap. 1004, Statutes of 2018) was signed by Governor Newsom on September 30, 2018. This bill was codified in the California Public Resources Code, Chapter 2, sections 42030-42036.4. This bill leveraged existing law regarding drug-take back provisions established under pharmacy law and federal law and medical waste management provisions administered by the California Department of Public Health to create a new stewardship program to ensure that a “covered entity” pays for the proper disposal of “covered products” shipped into California. This Board was given certain enumerated responsibilities under the bill. The bill requires the following with respect to the Board of Pharmacy:

  • “Covered entities” had to report to the Board by April 1, 2021 a list of the “covered products” and a list of drugs or sharps that are not covered products that it sells or offers for sale in California. Pub. Resources Code section 42031(a)(1).
  • By January 15 each year, a “covered entity” or the stewardship program to which it belongs must update its list of “covered products” and uncovered products with Board. Pub. Resources Code section 42031(a)(2).
  • Retail pharmacies that sell a covered product under its own store label were required to notify the Board of the “covered entity” that supplied the retail pharmacy with its store label covered products. Pub. Resources Code section 42031(b).
  • The Board must verify the information received from covered entities regarding its covered products and from retail pharmacies identifying the supplier of any store label covered products. Pub. Resources Code section 42031(c).
  • The Board also must review proposed stewardship plans for compliance with pharmacy law and make a determination whether the plan complies with pharmacy law. Pub. Resources Code section 42032(b).

The Board has other authorized duties under this law. However, primary oversight over the implementation of this new program lies with the California Department of Resources Recycling and Recovery (CalRecycle), including final approval of stewardship plans and enforcement of these new provisions.

You can email the list of covered and non-covered products to BOPStewardship@dca.ca.gov. The Board provides a template to facilitate the submission and its review. Pursuant to Public Resources Code (PRC) section 42031(a)(1), a covered entity must submit both a list of covered products, and a “a list and description of any drugs or sharps that are not covered products”, that is sells or offers for sale in California, to the Board. A covered entity is responsible for the accuracy and completeness of the list.

Reference: PRC 42031(a)(1)

Revised November 2023

Public Resources Code section 42031(a)(2) specifies that a covered entity or a stewardship organization on behalf of a group of covered entities shall submit an updated list with highlighted changes to the Board on or before January 15 of each year or upon request.

Reference: PRC 42031(a)(2)

Revised November 2023

Yes. Pursuant to Public Resource Code section 42030 (g), “covered product” means a covered drug or home-generated sharps waste. Auto-injectors and prefilled syringes are “covered products” unless they meet the exclusion criteria set forth in PRC 42030(e)(2) or PRC 42030(I)(2).

Reference: PRC 42030(g)

Revised November 2023

Yes. Intramuscular injection needles, such as the ones for testosterone injection, are used to penetrate skin for the delivery of medication. They are “home-generated sharps waste” pursuant to Health & Safety Code (HSC) Section 117671, and thus “covered products” pursuant to Public Resource Code section 42030 (g).

Reference: PRC 42030(g); HSC 117671

Revised November 2023

Pursuant to California Code of Regulations (CCR), tit. 16 section 1776.1(e), medical sharps and needles shall not be deposited into a drug take-back kiosk. Under Business and Professions Code (BPC) section 4146, a pharmacy is permitted but not required to accept sharps containers.

Please check https://www.calrecycle.ca.gov/epr/pharmasharps/sharps/ for more information about sharps waste stewardship.

Reference: CCR 1776.1(e); BPC 4146

Revised November 2023

Pursuant to Public Resource Code section 42030(e)(1), a “covered drug” means a drug sold, offered for sale, or dispensed in or into the State of California. Additionally, Business and Professions Code sections 4024 and 4016 defines “dispense” and “administer”, respectively.

Based on the relevant sections of the law, a drug that is SOLELY administered in clinical settings within the definition of BPC section 4016, and not offered, sold or dispensed to a patient in California, would not be considered a “covered drug”. Public Resources Code section 42031(a)(1) requires that “covered entities” submit a list of covered and uncovered products, and the Board prefers that potential covered entities submit to the Board a statement why its drugs should not be considered “covered drugs” based on any such statutory interpretation. The potential covered entity is responsible for the truthfulness of such statement.

Reference: PRC 42030(e)(1); BPC 4016, 4024

Revised November 2023

APIs are not finished drugs, thus not “covered drugs” pursuant to Public Resource Code section 42030(e).

Reference: PRC 42030(e)

Revised November 2023

Please refer to Public Resource Code section 42030(f) for the definition of “covered entity”. Please contact CalRecycle at pharmasharpsenforcement@calrecycle.ca.gov for interpretive questions regarding a “covered entity”.

Reference: PRC 42030(f)

Revised November 2023

Pursuant to California Public Resource Code 42035(a)(1), on or before June 30, 2022, CalRecycle will post on its Internet Web site (https://www.calrecycle.ca.gov/epr/pharmasharps) a list of stewardship organizations, including entities with an approved stewardship plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the stewardship plans that are in compliance with this chapter. The law does not require posting of a list of “covered products”.

Reference: PRC 42035(a)(1)

Revised November 2023

You can find information about potential stewardship organizations at https://www.calrecycle.ca.gov/epr/pharmasharps/coveredentities You can find information about Pharmaceutical Stewardship Plans at https://www.calrecycle.ca.gov/epr/pharmasharps/pharma/plan, and Home-Generated Sharps Waste Plans at https://www.calrecycle.ca.gov/epr/pharmasharps/sharps/plan.

Revised November 2023

A wholesaler may be considered a “covered entity” per the tiered definition under Public Resource Code 42030(f). Wholesalers should coordinate with appropriate entities in their supply chains to determine how statutory and regulatory requirements will be met.

In addition, a wholesaler has the reporting responsibility pursuant to Public Resource Code 42035(c). A wholesaler shall determine if covered products are in compliance with the law, by verifying that the covered entities providing the covered products are in compliance with the law and shall notify CalRecycle if it determines that the covered entity is not listed on CalRecycle’s Internet Web site.

Reference: PRC 42030(f), Reference: PRC 42035(c)

Revised November 2023

A pharmacy can contact approved stewardship plan operators for participating in the program. Please check https://www.calrecycle.ca.gov/epr/pharmasharps/coveredentities/for approved stewardship plans and their contact information.

Revised November 2023

Compounded medications are exempted from section 505 of the Federal Food, Drug and Cosmetics Act (21 U. S.C. 355). Therefore, compounded medications are not “covered drugs” under the stewardship program.

Reference: PRC 42030(e)(1)

Revised November 2023

The intent of the SB212 is to ensure the safe disposal of pharmaceutical and home- generated sharps wastes. In the spirit of the law, the Board does not view it as a violation of law if a covered entity voluntarily elects non-covered drugs to be covered under a stewardship plan.

Reference: PRC 42030(e)(1)

Revised November 2023

You can find more information at CalRecycle’s web site: https://www.calrecycle.ca.gov/epr/pharmasharps. Questions regarding “covered drugs” or “covered products” should be directed to bopstewardship@dca.ca.gov. Questions regarding “covered entity” and other provision of SB212 should be directed to pharmasharpsenforcement@calrecycle.ca.gov

Revised November 2023

Public Resource Code 42030(e)(1)(B) states a drug marketed under an over-the-counter drug monograph is a “covered drug”. Pursuant to Public Resource Code 42030(e)(1)(A), non-prescription drugs (over-the counter drugs) marketed under NDA or ANDA pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act or Section 351 of the Federal Public Health Service Act are also “covered drugs”. There are some exclusions pursuant to Public Resource Code 42030(e)(2)(C). Please note whether a product is a cosmetic or/and a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. The Board recommends potential covered entities examine their over-the-counter drugs for their intended uses and contact appropriate agents, including potentially a lawyer, for guidance of whether their particular product is a covered drug.

Reference: PRC 42030(e)(1)(A); 42030(e)(1)(B); 42030(e)(2)(C); FDA Is It a Cosmetic, or a Drug, or Both?

Revised November 2023

Yes. Pursuant to PRC 42030(e)(1), “covered drug” includes drugs that were sold, offered for sale or dispensed in the state of California. If the drug is no longer produced or no longer for sale, it could still be considered a “covered drug” under the law.

Revised November 2023

No. PRC 42031(a) states a covered entity shall provide a list of covered products and a list of any drugs of sharps that are not covered products, that it sells or offers for sale in the state to the Board. While a drug may still be covered, the covered entity does not need to report it if the drug is no longer for sale in the State of California.

Revised November 2023

Licensees

Pharmacy Technician Expanded Duties

BPC 4115(b) was clarified by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025). Under these updates, which become effective January 1, 2026, a certified pharmacy technician as defined in BPC 4202 may perform the following duties under specified conditions:

  • Prepare and administer influenza and COVID-19 vaccines via injection or intranasally
  • Prepare and administer epinephrine
  • Perform specimen collection for tests that are classified as CLIA
  • Initiate and receive prescription transfers and accept clarification on prescriptions

Initiate and receive prescription transfers and accept clarification on prescriptions

Revised November 2025

The law establishes several conditions, as follows:

  • The duties are performed under the direct supervision and control of a pharmacist.
  • The pharmacy has scheduled another pharmacy technician to assist the pharmacist by performing the tasks provided in BPC 4115(a) (i.e., packaging, manipulative, repetitive, or other nondiscretionary tasks).
  • The pharmacy technician is certified pursuant to the provisions of BPC 4202(a)(4) and maintains the certification.
  • Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), which takes effect on January 1, 2026, clarifies the conditions for technicians performing administration of vaccines (or epinephrine):
    • Prior to performing administration of vaccines, the pharmacy technician has successfully completed at least six hours of practical training approved by the Accreditation Council for Pharmacy Education that includes hands-on injection technique, the recognition and treatment of emergency reactions to vaccines, and an assessment of the pharmacy technician’s injection technique.
    • The pharmacy technician is certified in basic life support.

[Reference: BPC 4115(b); see also Stats. 2025, Ch. 196, Sec. 36 (AB 1503), effective January 1, 2026]

Revised November 2025

Licensees

Unprofessional Conduct

Yes. Effective January 1, 2024, the unprofessional conduct code was amended to expand the list of specified actions that constitute unprofessional conduct to include actions or conduct that would subvert the efforts of a pharmacist or PIC to comply with laws and regulations, or exercise professional judgment.

[Reference: BPC 4301(v) and (w)]

Revised November 2025

A consumer or licensee may file a complaint with the Board online. Fill out the boxes on the form that apply to your complaint. The Board requests that documentation or other evidence that support your allegations be retained and provided to the Board if requested.

Revised November 2025

Yes. The Board welcomes and investigates complaints received, including anonymous complaints. However, anonymous complaints may limit the Board’s ability to investigate.

Revised November 2025

Subdivision (c) of BPC 4113.6 (which was added by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), and which becomes effective on January 1, 2026) provides that a chain community pharmacy is required to post, in a prominent place for pharmacy personnel, a notice that provides information on how to file a complaint with the Board.

[Reference: Stats. 2025, Ch. 196, Sec. 35 (AB 1503), effective January 1, 2026]

Revised November 2025

Licensees

Surgical Clinic Provisions

The Surgical Clinic Self-Assessment Form can be found here on the Board’s website.

[Reference: BPC 4192(b)]

Revised November 2025

Effective January 1, 2024, as part of the renewal process for a surgical clinic, the consulting pharmacist must certify compliance with the quarterly inspections as required by BPC 4192. Further, as part of the renewal process of every odd-numbered year, the most recent self-assessment form completed as provided in BPC 4192 must be provided to the Board.

[Reference: BPC 4204(c)]

Revised November 2025

The renewal application form includes a statement that must be completed by the consulting pharmacist as part of the renewal process. As a reminder, the Board has a policy to accept digital signatures. The policy is available here.

[Reference: BPC 4192(b), 4204(c)]

Revised November 2025

A copy of the completed self-assessment form can be mailed along with the renewal application form and renewal fee to the Board’s office at 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833.

Alternatively, the self-assessment form may be emailed to surgicalclinicselfassessment@dca.ca.gov and the renewal application form and fee may be mailed to the Board’s office.

[Reference: BPC 4204(c)]

Revised November 2025

Licensees

Compounding Regulations

Title 16, California Code of Regulations (CCR), Sections 1735 et seq., 1736 et seq., 1737 et seq., and 1738 et seq.

Regulations Effective October 1, 2025

This information is intended solely to assist pharmacists and pharmacies with understanding the California regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals that took effect on October 1, 2025. It is not nor is it a substitute for legal advice. References to specific sections of the regulations are provided to aid the users of this document. Licensees are strongly encouraged to read the regulations in their entirety to have full understanding of the requirements. Licensees are also reminded that the regulations are in addition to (not in replacement of) applicable state and federal law and USP standards, and are advised that this document only addresses the additional requirements that apply under the regulations. All references in this document to California Business and Professions Code (BPC) sections are in Division 2, Chapter 9. All references in this document to California Code of Regulations (CCR) sections are in Title 16. Licensees are also advised that this is a dynamic document, which may be updated periodically.

General Compounding

Type of Compounding Previous CCR Current CCR USP Related Chapters
Nonsterile compounding 1735 – 1735.8 1735 – 1735.15 USP 795
Sterile compounding 1735 – 1735.8 and 1751 – 1751.10 1736 – 1736.21 USP 797
Handling of hazardous drugs 1735 – 1735.8 and 1751 – 1751.10 1737 – 1737.17 USP 800
Radiopharmaceutical- preparation, compounding, dispensing and repackaging 1708.3 – 1708.5, 1735 – 1735.8, and 1751 – 1751.10 1738 – 1738.14 USP 825

Revised January 2026

For nonsterile and sterile compounding, “designated person(s)” means one or more individuals assigned by the pharmacist-in-charge (PIC) to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of the compounded nonsterile preparations (CNSPs)/ compounded sterile preparations (CSPs), as applicable. Nothing in this definition allows for a designated person to exceed the scope of their issued license. When the designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the professional judgment of a pharmacist. Nothing in this definition prohibits the PIC from also serving as the designated person.

For hazardous drugs (HDs), in a pharmacy, the “designated person(s)” must be approved by the PIC to be responsible and accountable for the performance and operation of the facility and personnel as related to the handling of HDs. The designated person(s) shall not exceed the scope of their issued license. When a designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the judgment of a pharmacist.

For radiopharmaceuticals, “designated person” means a pharmacist identified as assigned, responsible, and accountable for the performance and operation of the radiopharmaceutical processing facility and for personnel who prepare, compound, dispense, and repackage radiopharmaceuticals. Nothing in this definition prohibits the PIC from also serving as the designated person.

[Reference: CCR 1735(b), 1736(c), 1737.2(a)(1), 1738(c)]

Revised January 2026

For nonsterile compounding: A facility may compound a drug in shortage when the drug product appears in an American Society of Health-System Pharmacists (ASHP) Drug Shortages List or FDA Drug Shortages Database of drugs that are in short supply at the time of compounding or within 60 days of the end of the shortage, or in a health care facility licensed pursuant to Health and Safety Code Section 1250 where the drug product cannot be obtained from the manufacturer or wholesaler and documentation is maintained.

For sterile compounding: A facility may compound a drug in shortage when that drug product appears in an ASHP Drug Shortages List or FDA Drug Shortages Database of drugs that are in short supply at the time of compounding and at the time of dispensing, or in a health care facility licensed pursuant to Health and Safety Code Section 1250 where the drug product cannot be obtained from the manufacturer or wholesaler and documentation is maintained.

[Reference: CCR 1735.1(e)(1)(A), 1736.1(e)(1)(A)]

Revised January 2026

For nonsterile compounding, sterile compounding, and the processing of radiopharmaceuticals, the regulations require that records be created and maintained in a manner to provide an audit trail for revisions and updates of each record document. Prior versions of each record must be maintained for at least three years from the date the record was created, modified, or relied on, in a readily retrievable format and include the changes to the document, identification of the individual who made each change, and the date of each change.

[Reference: CCR 1735.14(b), 1736.20(b), 1738.9(d)]

Revised January 2026

Questions regarding your compounding license, license renewal, or general licensing questions can be submitted to Compounding.Pharmacy@dca.ca.gov.

Revised January 2026

Under the regulations, “essentially a copy” of a commercially available drug product means a preparation that includes the same active pharmaceutical ingredient(s) (API(s)) as the commercially available drug product, except that it does not include any preparation in which there has been a change made for an identified individual patient that produces for that patient a clinically significant difference, as verified and documented by the pharmacist, between that compounded preparation and the comparable commercially available drug product.

[Reference: CCR 1735(d), 1736(e)]

Revised January 2026

Any person assigned to provide the training specified in section 1735.2 (applicable to nonsterile compounding) or section 1736.2 (applicable to sterile compounding) shall have demonstrated competency in the skills in which the person will provide training or observe and measure competency described in the facility’s standard operating procedures (SOPs).

[Reference: CCR 1735.2(c), 1736.2(e)]

Revised January 2026

For nonsterile or sterile compounding, any garbing accommodations provided by the designated person shall be documented, and the documentation shall include the name of the individual granted the accommodation, date granted and description of the reasons for granting the accommodation.

[Reference: CCR 1735.3(f), 1736.3(e)]

Revised January 2026

For nonsterile or sterile compounding, a CR shall, upon request, be produced as a single document.

[Reference: CCR 1735.7(c), 1736.11(c)]

Revised January 2026

The facility’s SOPs for nonsterile compounding must describe the validated processes for storage, for shipping containers (as applicable), and for transportation of temperature sensitive CNSPs (as applicable) to preserve quality standards for integrity, quality and labeled strength. For sterile compounding, there must be written procedures for qualification of storage, shipping containers and transportation of temperature sensitive CSPs to preserve quality standards for integrity, quality, and labeled strength.

[Reference: CCR 1735.11(a)(2)(D), 1736.17(g)]

Revised January 2026

Nonsterile Compounding

Yes, reconstitution of a conventionally manufactured drug product that is not done in accordance with the FDA approved directions is

[Reference: CCR 1735.1(b)]

Revised January 2026

A limited quantity of a CNSP may be prepared and stored in advance of receipt of a patient specific prescription document where it is necessary, and solely in such quantity to ensure continuity of care of individual patients based on a documented history of prescriptions for those patient populations.

[Reference: CCR 1735.1(c)]

Revised January 2026

A reasonable quantity of CNSP may be furnished to a veterinary office for use by the veterinarian that is sufficient:

  1. for administration or application to veterinary patients solely in the veterinarian’s office.
  2. for furnishing of no more than a 14-day supply, for an individual patient, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing.

[Reference: CCR 1735.1(d)]

Revised January 2026

Gloves must be wiped or replaced before beginning a CNSP that contains different components.

[Reference: CCR 1735.3(d)]

Revised January 2026

If a source is referenced to support an assigned BUD, the source referenced must be readily retrievable at the time of compounding and must be maintained for three (3) years from the date each CNSP is dispensed.

[Reference: CCR 1735.7(a)(1)]

Revised January 2026

Yes, a CSNP’s label shall include the name of the compounding facility and the name of the dispensing facility, if different.

[Reference: CCR 1735.9(a)(2)]

Revised January 2026

Yes, if the testing is compliant with USP Chapter 51, Antimicrobial Effectiveness Testing. If such testing is used, or if relying upon current published peer-reviewed literature sources, the reference or test in its entirety shall be readily retrievable in accordance with Business and Professions Code section 4081 for three years from the last date the CNSP was dispensed.

[Reference: CCR 1735.10(c)]

Revised January 2026

Yes, the facility’s SOPs for nonsterile compounding must include the methods a pharmacist will use to determine and approve the ingredients and the compounding process for each preparation before compounding begins.

[Reference: CCR 1735.11(a)(2)(C)]

Revised January 2026

Under the regulations, a facility that limits its compounding to combining a flavoring agent with a prescribed FDA approved drug in an oral liquid dosage form at the request of a prescriber, patient, or patient’s agent is exempt from certain sections of the regulations, as specified in subdivision (i) of section 1735.1. However, for such facilities, section 1735.15 requires, among other things, that the pharmacist adding the flavoring agent must document the compounding in the prescription or compounding record.

A facility that performs any other form of nonsterile compounding at any time does not qualify for the exemption described above.

Licensees are advised to read the regulations referenced below in their entirety for a full understanding of the requirements regarding adding flavoring agents.

[Reference: CCR 1735.1(i), 1735.15]

Revised January 2026

Sterile Compounding

Except as described in the two bullet points below, compounded sterile preparations (CSPs) for direct and immediate administration as provided in USP Chapter 797 shall only be compounded in those limited situations where the failure to administer such CSP could result in loss of life or intense suffering of an identifiable patient.

  • If the sterile compounding equipment or environment fail(s) to meet any required specification, after attempts to remediate pursuant to the facility’s SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient; however, this provision may only be used for 48 hours after such failure(s).
  • If the sterile compounding equipment or environment fail(s) to meet any required specification in a critical access hospital, as defined in section 1395i-4(c)(2)(B) of title 42, United States Code, after attempts to remediate pursuant to the facility’s SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient; however, this provision may only be used for 120 hours after such failure(s).

Licensees are advised to read the regulation in its entirety for a full understanding of the requirements that apply to immediate-use CSPs.

[Reference: CCR 1736.1(b)]

Revised January 2026

A reasonable quantity of a CSP may be furnished to a veterinary office for use by the veterinarian that is sufficient:

  1. for administration or application to veterinary patients solely in the veterinarian’s office.
  2. for furnishing of not more than a 7-day supply for an individual patient, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing, with the exception of a topical ophthalmic where up to a 28-day supply may be furnished to the veterinarian’s office for an individual patient; provided that such topical ophthalmics shall be compliant with USP Chapter 797 section 14.5, Multiple-Dose CSPs.

[Reference: CCR 1736.1(d)]

Revised January 2026

Yes, if all of the following conditions are met:

  • The Standard Operating Procedures (SOPs) required by section 1736.17 related to compounding are identical.
  • The Secondary Engineering Control (SEC) facility designs are sufficiently similar to accommodate the use of the same SOPs.
  • The Primary Engineering Controls (PECs) are of the same type and sufficiently similar to accommodate the use of the same SOPs describing use and cleaning.

[Reference: CCR 1736.2(b)]

Revised January 2026

Compounding personnel or persons with direct supervision and control of compounding personnel who fail any aspect of the aseptic manipulation ongoing training and competency evaluation shall not be involved in compounding of a CSP until after successfully passing training and competency in the deficient area(s) as detailed in the facility’s SOPs.

A person with only direct supervision and control of personnel who fails any aspect of the aseptic manipulation ongoing training and competency evaluation may continue to provide only direct supervision and control of personnel for no more than 30 days after a failure of any aspect while applicable aseptic manipulation ongoing training and competency evaluation results are pending.

[Reference: CCR 1736.2(d)]

Revised January 2026

Yes, as long as the wall is smooth, impervious, free from cracks and crevices, and non-shedding so it can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.

[Reference: CCR 1736.4(b)]

Revised January 2026

Yes, as long as the wall is smooth, impervious, free from cracks and crevices, and non-shedding so it can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.

[Reference: CCR 1736.4(b)]

Revised January 2026

The temperature shall be monitored in each room of the designated compounding area each day that compounding is performed, either manually or by a continuous recording device.

[Reference: CCR 1736.4(c)]

Revised January 2026

No, an existing secondary engineering control that has a pass-through that is not an interlocking device may continue to be used if the SOPs document that two doors may not be opened at the same time.

Where a pass-through is installed in a secondary engineering control After October 1, 2025, the doors must be interlocking.

[Reference: CCR 1736.4(d)]

Revised January 2026

In addition to the requirements of USP Chapter 797, testing and certification of all ISO classified areas shall be performed by a qualified technician in accordance with Controlled Environment Testing Association’s (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003, Revised October 2022). The CETA standard(s) used to perform certification testing in all ISO classified areas shall be recorded on the report issued by the certifying technician in accordance with the Certification Guide for Sterile Compounding Facilities.

[Reference: CCR 1736.5]

Revised January 2026

In addition to the requirements of USP Chapter 797, environmental sampling shall be done in accordance with the Controlled Environment Testing Association’s Certification Application Guide USP <797> Viable Environmental Monitoring for Sterile Compounding Facilities (CAG-009, Revised September 2020).

[Reference: CCR 1736.6]

Revised January 2026

Incubators used by the facility shall be cleaned, maintained, calibrated, and operated in accordance with manufacturers’ specifications. For incubators without specific manufacturers’ specifications, cleaning shall take place at least every 30 days and calibration shall take place at least every 12 months. Temperatures must be monitored either manually or by a continuous recording device during incubation, and the results shall be reviewed and documented as described in the facility’s SOPs.

[Reference: CCR 1736.9(b)]

Revised January 2026

If a component included in the published 503A Category 1 Bulk Drug Substances List is used, it must be found suitable for sterile drug preparations as provided in USP Chapter 797, Section 9.3 Components. The facility’s SOPs shall establish a process to determine the quality of the API, and the SOPs, which must comply with USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding, must define both the methods by which the pharmacist compounding or supervising the compounding will ensure the quality of compounded drug preparations and the methods used to determine and approve components and the compounding process for each preparation before compounding begins.

Licensees are advised to read Article 4.6 (Sterile Compounding) of the regulations in its entirety for a full understanding of the requirements that apply to components used to compound CSPs.

[Reference: CCR 1736.9(f), 1736.17(a)]

Revised January 2026

Section 1736.10 of the regulations describes requirements, in addition to the requirements in USP Chapter 797, that apply to sterilization and depyrogenation. Subdivision (e) of section 1736.10 states that no compound of a CSP from nonsterile components shall be prepared when the licensed location cannot also sterilize the CSP as described in section 1736.10.

[Reference: CCR 1736.10(e)]

Revised January 2026

Yes. A pharmacist performing or who has direct supervision and control of compounding personnel is responsible for ensuring injectable CSPs made from nonsterile components, regardless of the USP Category, are tested to ensure that they do not contain excessive bacterial endotoxins, as established in USP Chapter 85, Bacterial Endotoxins.

Results shall be reviewed and documented in the compounding record prior to furnishing.

[Reference: CCR 1736.12(c)]

Revised January 2026

A compounded stock solution intended for use in a CSP must comply with all provisions of Article 4.6 (Sterile Compounding) of the regulations and USP Chapter 797 Category 1, Category 2, or Category 3.

[Reference: CCR 1736.16(a)]

Revised January 2026

Yes, as long as the outsourcing facility is licensed in California.

NOTE: To verify if an outsourcing facility is licensed in California, go to: https://search.dca.ca.gov/?BD=7200&TP=180

[Reference: CCR 1736.16(b)]

Revised January 2026

Hazardous Drugs (HD)

No, although the regulations provide a grace period to come into compliance. Where there is a pass-through in a C-SEC, the doors must be gasketed and interlocking by January 1, 2027.

[Reference: CCR 1737.5(c)]

Revised January 2026

On or after January 1, 2028, prior to installing a new pass-through, a facility must consider the use of a HEPA purge type pass-through. Documentation shall be maintained showing compliance with this requirement if such a pass-through is not used.

[Reference: CCR 1737.5(d)]

Revised January 2026

Continuing Education

Pharmacists

RPH licensees are required to complete 30 CE hours during the two years preceding the application for renewal. This must include:

  • At least two hours of participation in a Board-provided CE course in Law and Ethics. [Note: Currently, the Board offers two separate webinars: a Board-provided law webinar (1 hour) and a Board-provided ethics webinar (1 hour). RPH licensees must view both webinars to satisfy the 2-hour Law and Ethics CE requirement. Click here to access both courses.]
  • At least one hour of participation in a cultural competency course.

[Reference: Business and Professions Code (BPC) section 4231; Title 16, California Code of Regulations (CCR) section 1732.5(a) – 1732.5(b).].

Approved June 2026

No, the Board does not require completion of CE for the first renewal of a pharmacist license.

[Reference: BPC section 4231.]

Revised June 2026

BPC section 4231 defines “cultural competency course” to mean a cultural competency and humility course that meets the following criteria:

  • The course focuses on patients who identify as lesbian, gay, bisexual, transgender, gender nonconforming, or queer, or who question their sexual orientation or gender identity and expression.
  • The course is approved from an accreditation agency approved by the Board.
  • The course covers recognized health disparities faced by Black, Indigenous, and people of color.
  • The course contains elements demonstrating how sexual identity is directly impacted through intersectionality.

[Reference: BPC section 4231.]

Revised June 2026

Yes, pharmacists who prescribe any Schedule II controlled substances shall complete at least one hour of the required CE hours by participating in a Board approved CE course once every four years on the risks of addiction associated with the use of Schedule II drugs.

[Reference: BPC section 4232.5 and CCR section 1732.5; Health and Safety Code section 11055.]

Revised June 2026

No. CE must be completed during the two years preceding the application for renewal.


[Reference: BPC section 4231; CCR section 1732.5(a).]

Revised June 2026

No. Under provisions in Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), effective January 1, 2026, pharmacists who perform these functions are no longer subject to specialized CE requirements. The Board is pursuing a regulation change to update its CE regulations to formally remove those specialized CE requirements.

Revised June 2026

Board-Provided Continuing Education (CE)

Registration for Board-provided Continuing Education (CE) programs is conducted through PharmEd. Learn more about current trainings available on PharmEd.

Revised June 2026

No. Please contact the NABP to learn about options to upload CE into the NABP CPE system.

Revised June 2026

Licensees may access certificates of completion for Board-provided CE courses via their PharmEd account dashboard.

Revised June 2026

Licensees interested in claiming CE for attending a Board or Committee meeting should follow the instructions included on the meeting agenda.

[Reference: CCR sections 1732.2(d) – 1732.2(e).]

Revised June 2026

Renewal Process

No. At the time of renewal, a pharmacist licensee renewing as active must simply enter on the renewal application the number of hours of CE successfully completed during the two years preceding the application for renewal.

[Reference: BPC section 4231; CCR section 1702 and 1732.5.]

Revised June 2026

A pharmacist license status will change to “CE Inadequate – License Held” if a pharmacist fails to numerically declare on their renewal application the number of hours of CE successfully completed during the preceding two years.

[Reference: BPC section 4231; CCR section 1702 and 1732.5.]

Revised June 2026

To restore the license status back to “active”, download a new renewal application and complete it in its entirety. The completed renewal application may be submitted via mail, fax or online.

Upon review and approval of the amended renewal application, the “active” license status will be reflected on the Board’s website.

Note: To ensure an online inquiry is appropriately routed, select “Renewal of an Individual” as the reason for your inquiry.

Revised June 2026

No. Currently, there is no provision in pharmacy law that authorizes the Board to grant an extension for licensees to complete the required CE for renewal of their license.

Revised June 2026

Yes, pharmacists may seek exemption from the CE requirements for renewal on the grounds of emergency or hardship by applying to the Board in writing setting forth the reasons why such exemption should be granted. Exemptions may be granted for such reasons as illness or full-time enrollment in a health professional school.

[Reference: BPC section 4234 and CCR section 1732.6.]

Revised June 2026

A licensee with an inactive license issued pursuant to BPC section 4231 may obtain an active license by paying the renewal fees due and submitting satisfactory proof to the Board that the licensee has completed all CE renewal requirements.

[Reference: BPC section 4231(e).]

Revised June 2026

CE Audits

Licensees shall retain their certificates of completion for four years following completion of a CE course to demonstrate compliance.

[Reference: CCR section 1732.5(e).]

Revised June 2026

The Board conducts CE audits to confirm whether licensees have completed their CE requirements. If a licensee has been selected for a CE audit, the Board will send a notification to the licensee’s address of record. Additionally, if available, the Board will send a notification to the licensee’s email address of record. As a reminder, licensees must notify the Board of any changes to their address of record within 30 days of the change.

Consistent with legal requirements, if, as part of an investigation or audit conducted by the Board, a licensee fails to provide documentation substantiating completion of required CE, the Board shall cancel the active license and issue an inactive license in its place.

[Reference: BPC sections 4100 and 4231(e).]

Revised June 2026

Continuing Education (CE) Providers

No, the Board does not maintain such a list.

Revised June 2026

CE courses must be relevant to the practice of pharmacy and, subject to certain exceptions (outlined in paragraphs 2-4 below), must be obtained from a provider who is recognized by one of the two accreditation agencies designated by the Board: the Accreditation Council for Pharmacy Education (ACPE) or the California Pharmacists Association (CPhA).

Additionally, coursework which meets the standard of relevance to pharmacy practice and has been approved for CE by the Medical Board of California, the California Board of Podiatric Medicine, the Dental Board of California, or the California Board of Registered Nursing shall, upon satisfactory completion, be considered approved CE for RPHs.

RPHs may also earn CE credit for completing certain Board-provided training courses. Click here to access current mandatory and elective Board-provided training webinars.

Finally, individuals may petition the Board to allow CE credit for specific coursework which is not offered by an accredited provider but meets the standard of relevance to pharmacy practice.

[Reference: BPC section 4232; CCR sections 1732, 1732.05(a), 1732.1, 1732.2, and 1732.3(e).]

Revised June 2026

Continuing Education (CE) courses shall be relevant to the practice of pharmacy as provided in CCR section 1732.3 and BPC section 4232 and related to one or more of the following topics:

  • the scientific knowledge or technical skills required for the practice of pharmacy
  • direct and/or indirect patient care
  • the management and operation of a pharmacy practice.

The subject matter shall be pertinent to the socioeconomic and legal aspects of health care, the properties and actions of drugs and dosage forms and the etiology, and characteristics and therapeutics of the disease state. The subject matter of the courses may include, but shall not be limited to, the following:

  • pharmacology
  • biochemistry
  • physiology
  • pharmaceutical chemistry
  • pharmacy administration
  • pharmacy jurisprudence
  • public health and communicable diseases
  • professional practice management
  • anatomy
  • histology
  • and any other subject matter as represented in curricula of accredited colleges of pharmacy

[Reference: BPC section 4232; CCR sections 1732.1(b), 1732.2, and 1732.3(e).]

Revised June 2026

Certificates of completion must contain the name of the enrollee, name and number of the course provider, title of the course, number of completed hours, date of completion, expiration date of the coursework, course number, if applicable, and the name of the accrediting agency.

[Reference: CCR section 1732.1(c).]

Revised June 2026

Continuing Education

Pharmacy Technicians

Effective January 1, 2024, TCH licensees must successfully complete at least one hour of participation in a cultural competency course each renewal period (i.e., every two years) (see Business and Professions Code section 4202(d)). Please note, all CE must be completed prior to signing and submitting your renewal application.

The term “cultural competency course” means a cultural competency and humility course that meets the following criteria, as outlined in Business and Professions Code section 4231(a):

  1. The course focuses on patients who identify as lesbian, gay, bisexual, transgender, gender nonconforming, or queer, or who question their sexual orientation or gender identity and expression.
  2. The course is approved from an accreditation agency approved by the Board.
  3. The course covers recognized health disparities faced by Black, Indigenous, and people of color.
  4. The course contains elements demonstrating how sexual identity is directly impacted through intersectionality.

Approved April 2024

No. The Board does not maintain a list of Continuing Education providers/courses and does not endorse or recommend any specific provider or course. The Board recommends that, prior to registering for any cultural competency course, licensees confirm compliance with the course provider to ensure the course meets the requirements set forth in Business and Professions Code section 4231(a).

Approved April 2024

You do not need to submit proof of completion of Continuing Education with your renewal application. If you are randomly selected for an audit of your CE compliance, the Board will send a letter to your address of record requesting proof of successful completion of Continuing Education.

Approved April 2024

Your license status has been changed to “Continuing Education Inadequate – License Held” because you failed to answer the continuing education question on your renewal application.

In order to change your license status back to “active”, you will need to download a new renewal application and complete it in its entirety: https://pharmacy.ca.gov/licensees/personal/tch.shtml.

Please email your completed renewal application so we may resolve this for you. Once Board staff has reviewed your amended renewal application, your updated license status will be reflected on the Board’s website.

Approved April 2024

No. Currently, there is no provision in pharmacy law for the Board to grant any Pharmacy Technician licensee an extension to complete the required Continuing Education for renewal of their license.

Approved April 2024

No. Currently, there is no provision in pharmacy law for the Board to grant a Pharmacy Technician licensee an exemption from completion of the required Continuing Education for renewal of their license.

Approved April 2024

No. However, if you hold a CPhT certificate, you may wish to contact the issuing organization (PTCB or NHA) directly regarding their Continuing Education requirements. The Board is not associated with PTCB or NHA.

Approved April 2024

Should you have any further questions, please send us a message via our contact us page.

Licensees

Digital Records

Yes, Business and Professions Code section 4105 states that paper records may be converted into a digital format. The section further provides that digitized records must be maintained in a noneditable format.

Approved April 2026

Pursuant to Business and Professions Code section 4105, the Board may require certification that digitized documents have not been altered.

Approved April 2026

A pharmacy will need to consult with other regulators and payors to confirm if they will similarly allow for digitized records.

Approved April 2026

All records required to be maintained pursuant to Chapter 9 of Division 2 of the Business and Professions Code, regardless of form (i.e., paper or digital/electronic), shall be retained for at least three years from the date of making. (See Bus. & Prof. Code §§ 4081, 4105, and 4333.)

Approved April 2026

Licensees

Electronic Data Transmission Prescriptions (E-Prescriptions)

Licensees of the California State Board of Pharmacy are subject to the e-prescribing requirements established by Assembly Bill (AB) 2789 (Wood, 2018). All prescriptions issued by a licensed healthcare practitioner to a California pharmacy must be submitted electronically. In addition, all California pharmacies must have the capability to receive prescriptions electronically.

Under California Business and Professions Code (BPC) section 688(b), a pharmacy must have the capability to receive an electronic data transmission prescription on behalf of a patient from a health care practitioner authorized to issue a prescription pursuant to BPC section 4040.

Reference: BPC 688(a), 688(b), 4040

Revised September 2021

BPC section 688(b) applies to both non-controlled and controlled substances with regard to a pharmacy’s capability to receive electronic data transmission prescriptions. However, under BPC section 688(c), a prescription for a controlled substance, as defined by BPC 4021, the electronic data transmission prescription must comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations (CFR). Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.

Reference: BPC 688(a) 688(b), 688(c), 4021; 21 CFR 1300, 1304, 1306, 1311

Revised September 2021

BPC section 688(i) states that a pharmacist who receives a written, oral, or faxed prescription is not required to verify that the prescription properly falls under one of the exceptions in subdivision (e). Pharmacists may continue to dispense medications from legally valid written, oral, or faxed prescriptions pursuant to this division.

Reference: BPC 688(i)

Revised September 2021

BPC section 688(g) states a pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient must, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester.

Reference: BPC 688(g)

Revised September 2021

BPC section 688(g) states a pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient must, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester.

Reference: BPC 688(g)

The Board of Pharmacy would strongly encourage licensees to contact their local DEA office for confirmation of DEA’s policy and the federal requirements related to the forwarding of an unfilled controlled substances prescription.

Revised September 2021

Record-keeping must comply with California Code of Regulations (CCR) section 1717(e) and 21 CFR 1306.25, if applicable

Revised September 2021

BPC section 688(b) states a pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to section 4040 must have the capability to receive an electronic data transmission prescription on behalf of a patient. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i).

Reference: BPC 688(b), 688(i)

Revised September 2021

BPC section 688(a) states a health care practitioner authorized to issue a prescription pursuant to section 4040 must have the capability to issue an electronic data transmission prescription, as defined under section 4040 on behalf of a patient and to transmit that electronic data transmission prescription to a pharmacy selected by the patient. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i). Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.

Reference: BPC 688(a), 688(i)

Revised September 2021

HSC section 11167.5 will remain effective in the applicable hospice and long-term care settings.

Reference: HSC 11159.2, 11167.5; BPC 688(e)(1)

Revised September 2021

Under certain circumstances as outlined in Health and Safety Code (HSC) section 11167.5, there may be instances where a long-term care or hospice care pharmacy may need to print the electronic transmission prescription. Additionally, BPC section 688(e)(4)(A)(B) references instances when a prescription must be electronically issued but does not require electronic transmission and may be provided directly to the patient. Controlled substance prescriptions provided directly to the patient also must comply with federal law. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i).

Reference: HSC 11167.5; BPC 688(e)(4)(A)(B), 688(i)

Revised September 2021

BPC section 688(a) is inclusive of all health care practitioners authorized to issue a prescription pursuant to BPC section 4040. As indicated in BPC section 688(b), a pharmacy must have the capability to receive an electronic data transmission prescription on behalf of a patient from all types of health care practitioners pursuant to BPC section 4040. BPC section 688(e)(7) provides a potential exemption if the health care practitioner and the dispenser are the same entity.

Reference: BPC 688(a), 688(b), 688(e)(7)

Revised September 2021

Under BPC section 688(e)(7), if the prescribing health care practitioner and dispenser are the same entity, electronic transmission prescriptions are not required. Based on the Board’s understanding of the scenario posed, “posting” of the prescription in an electronic medical record for dispensing by a pharmacy of the same entity meets the intent of California law. Controlled substance prescriptions must also comply with federal law.

Reference: BPC 688(a)(d)(e)(7)

Revised September 2021

As described in BPC 688(e)(7), “same entity” refers to the same health care system which may or may not be the same physical location.

Reference: BPC 688(e)(7)

Revised September 2021

BPC section 688(d) would not be applicable to a health care practitioner prescribing a prescription pursuant to subdivision (e). However, the health care practitioner must have the capability to issue and transmit an electronic data transmission prescription as defined under BPC section 4040 and BPC section 688(a). Note: The California State Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.

Reference: BPC 688(a), 688(d), 688(e), 4040

Revised September 2021

BPC section 4040(c) describes an “electronic data transmission prescription” as any prescription order other than an electronic image prescription that is electronically transmitted from a licensed prescriber to a pharmacy. An email could potentially qualify as an electronic data transmission prescription for noncontrolled substances; however, this does not appear to meet the spirit of the law. However, under BPC section 688(c), a prescription for a controlled substance as defined by BPC section 4021, the electronic data transmission prescription must comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations (CFR).

Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.

Reference: BPC 4040(c), 4021, 688(c); 21 CFR 1300, 1304, 1306, 1311

Revised September 2021

BPC section 688 does not address the modification of an electronic data transmission prescription. For a noncontrolled and Schedule III-V prescription, a pharmacy may reduce the oral prescription to writing as described in BPC section 4070(a) and HSC section 11164(b). Note: DEA registrants also must comply with federal law regarding controlled substances.

Reference: BPC 688, 4070(a); HSC 11164(b)

Revised September 2021

The law does not require pharmacists to notify the respective regulatory agency of issues of non-compliance, but they may choose to do so.

Reference: BPC 688(j)

Revised September 2021

BPC section 688(k) indicates this section must not apply in the scenario described. However, if an inmate, individual on parole, or youth is not under the jurisdiction of the Department of Corrections and Rehabilitation, BPC section 688 would apply.

Reference: BPC 688(k)

Revised September 2021

Ask an Inspector

Pharmacist and Technician / Intern Duties and Identification

There are multiple provisions of law that address this question, and the answer varies based on various factors. Relevant legal references include:

  1. With respect to interns, section 1726 of title 16 of the California Code of Regulations states that a pharmacist supervising an intern shall be responsible for all professional activities performed by the intern under his or her supervision.
  2. With respect to pharmacy technicians, section 1793.7 of title 16 of the California Code of Regulations states that any function performed by a pharmacy technician in connection with dispensing of a prescription, including repackaging from bulk, must be verified and documented in writing by a pharmacist. Except for certain situations outlined in the regulation, the pharmacist shall indicate verification of the prescription by initialing the prescription label before the medication is provided to the patient. (See also Business and Professions Code section 4115.5(b)(3) for similar provisions with respect to pharmacy technician trainees.)
  3. Pursuant to section 1712 of title 16 of the California Code of Regulations, section 1793.7’s requirement for the pharmacist to initial the prescription label can be satisfied by recording the identity of the reviewing pharmacist in a computer system by a secure means. The computer used to record the reviewing pharmacist's identity shall not permit such a record to be altered after it is made, and the record of the reviewing pharmacist's identity made in the computer system must be immediately retrievable in the pharmacy.

Revised June 2025

Business and Professions Code section 4114(b) provides that a pharmacist may not supervise more than two interns at one time.

Revised June 2025

Business and Professions Code section 4115(g) specifies as follows:

  1. A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (a) of Business and Professions Code section 4115 (i.e., packaging, manipulative, repetitive, or other nondiscretionary tasks).
  2. A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (b) of Business and Professions Code section 4115 (these include preparation and administration of certain vaccines and/or epinephrine, performing specimen collection for CLIA-waived tests, receiving prescription transfers, and accepting clarification on prescriptions, subject to specified conditions). If a pharmacy technician is performing the tasks specified in subdivision (b), a second pharmacy technician shall be assisting a pharmacist with performing tasks specified in subdivision (a).
  3. The ratio of pharmacy technicians increases for each additional pharmacist to a ratio not to exceed 2 technicians to 1 pharmacist for pharmacy technicians performing the tasks specified in subdivision (a).
  4. A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of their professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities under Pharmacy Law. (See paragraph (3) of subdivision (g) of Business and Professions Code section 4115 for specific conditions that apply in such situations.)

Revised June 2025

Yes. According to California Code of Regulations, title 16, section 1793.7(c), a pharmacy technician must wear identification clearly identifying him or her as a pharmacy technician. In addition, Business and Professions Code section 680(a) states, in pertinent part: “Except as otherwise provided in this section, a health care practitioner [which includes a pharmacist; see section 680(c)] shall disclose, while working, his or her name and practitioner's license status, as granted by this state, on a name tag in at least 18-point type. A health care practitioner in a practice or an office, whose license is prominently displayed, may opt to not wear a name tag.”

Example: If your name is John Doe, the following formats are acceptable:

John Doe, RPh
Pharmacist
John Doe
Pharmacist
J. Doe
Pharmacist
John D.
Pharmacist
Johnny
Pharmacist
John
Pharmacist

Revised June 2025

Ask an Inspector

Hypodermic Needles and Syringes (Over-The-Counter Sales)

Yes, but with a few restrictions and requirements. Please see Business and Professions Code sections 4144.5, 4145.5, and 4146 for the complete requirements.

A pharmacist or physician MAY (but is not mandated to) furnish hypodermic needles and syringes for human use without a prescription, if the furnisher has previously been provided with a prescription or other proof of legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment.

Additionally, until January 1, 2026, as a public health measure, the pharmacist or physician MAY (but is not mandated to), without a prescription, furnish hypodermic needles and syringes for human use to a person 18 years or older solely for personal use. A pharmacy that furnishes nonprescription hypodermic needles and syringes must counsel the consumer on the safe disposal of syringes or needles and provide the consumer with one or more of the following disposal options:

  1. Onsite disposal that meets applicable state and federal standards for collection and disposal of medical sharps waste.
  2. Mail-back sharps containers authorized by the USPS that meet applicable state and federal requirements for the transport of medical sharps waste, with tracking forms to verify destruction at a certified disposal facility.
  3. A sharps container that meets applicable state and federal standards for collection and disposal of medical sharps waste.

Until January 1, 2026, the pharmacy must also provide written information or verbal counseling to the consumer at the time of furnishing or sale of nonprescription hypodermic needles or syringes on how to (1) access to drug treatment, (2) access testing and treatment for HIV and hepatitis C, and (3) safely dispose of sharps waste.

A pharmacy may accept the return of needles and syringes from the public if contained in a sharps container, as defined in section 117750 of the Health and Safety Code.

Business and Professions Code section 4144.5 allows a pharmacy to sell hypodermic needles and syringes without a prescription for uses that the Board determines are industrial. In addition, Business and Professions Code section 4145.5(c) allows a pharmacist to furnish hypodermic needles and syringes without a prescription for use on animals.

Revised June 2025

Ask an Inspector

Controlled Substances: Prescribing, Filling, and Refilling

Health & Safety Code section 11200(c) prohibits the refilling of a prescription for a Schedule II controlled substance. (Also see 21 U.S.C. 829(a).) However, pursuant to Business and Professions Code section 4052.10, a pharmacist may partially fill a Schedule II controlled substance prescription as requested by the patient or prescriber. If a pharmacist dispenses a partial fill on a prescription under section 4052.10, the pharmacy must retain the original prescription, with a notation of how much of the prescription has been filled, until the prescription has been fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed. The full prescription shall be dispensed not more than 30 days after the date on which the prescriptions was written. See Business and Professions Code section 4052.10 for complete requirements regarding partial fills of Schedule II controlled substance prescriptions; see also 21 U.S.C. 829(f) and 21 CFR 1306.13.

Revised June 2025

Health & Safety Code section 11200(a) specifies that no person shall dispense or refill a controlled substance prescription more than six months after the date thereof. See also Health & Safety Code section 11166, providing: “No person shall fill a prescription for a controlled substance after six months has elapsed from the date written on the prescription by the prescriber.”

Revised June 2025

Health & Safety Code section 11200(b) specifies that no prescription for a Schedule III or IV controlled substance may be refilled more than five times. Further, this section also creates a limit of a 120-day total supply for refills of a Schedule III or IV controlled substance prescription.

Example: A prescription is written for temazepam 15mg QHS (a Schedule IV controlled substance), quantity #30 with 5 refills. The prescription is dispensed on 7/1/2016 for a quantity of 30. The pharmacy refills the prescription on 8/1/2016, 9/1/2016, 10/1/2016, and 11/1/2016, a 30-day supply for each refill and a total of a 120-day supply between the four refills. Although the prescriber wrote for 5 refills, the pharmacy cannot dispense the remaining refill because the 120-day limit was reached after dispensing the refill on 11/1/2016. A new prescription is required for any additional dispenses.

Revised June 2025

Health & Safety Code section 11153(a) states that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Health & Safety Code section 11153(a) further provides that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. In addition, subdivision (b) of section 1761 of title 16 of the California Code of Regulations states: “Even after conferring with the prescriber, a pharmacist shall not compound or dispense a controlled substance prescription where the pharmacist knows or has objective reason to know that said prescription was not issued for a legitimate medical purpose.”

NOTE: Additional information about corresponding responsibility can be found using the following link - - http://www.pharmacy.ca.gov/publications/corresponding_responsibility.pdf. Information on the Board’s precedential decision on corresponding responsibility can be found at http://www.pharmacy.ca.gov/enforcement/precedential.shtml. The DEA Pharmacist’s Manual, available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EODEA154R1)_Pharmacist's_Manual_DEA.pdf, includes an overview of a pharmacist’s duty of corresponding responsibility under federal law.

Revised June 2025

Ask an Inspector

CURES Requirements

Health & Safety Code section 11165.1(a)(1)(A)(ii) requires that a pharmacist shall, upon licensure, submit an application to the California Department of Justice to obtain approval to electronically access the CURES system. The California Department of Justice website to register for CURES is: https://cures.doj.ca.gov/register/pre-registration

Revised June 2025

Health & Safety Code Section 11165(d) specifies that a dispensing pharmacy must report information to the Department of Justice as soon as reasonably possible, but not more than one working day after the controlled substance is dispensed.

Revised June 2025

Ask an Inspector

Public Resources and Consumer Information

You may sign up for the Board’s email distribution list by visiting the following website and signing up: https://www.pharmacy.ca.gov/webapplications/apps/subscribe/index.shtml

Revised June 2025

Go to the Board’s website, www.pharmacy.ca.gov; click on the “Consumers” menu, then select “Information for Consumers”; and click on “Drug Takeback Search and Information.”

Revised June 2025

Ask an Inspector

Remote Verification and Shared Electronic Files

There are two provisions in the law that allow for remote verification of chart orders.

Business & Professions Code section 4071.1(d)(1) states that a pharmacist located and licensed in California may, on behalf of a health care facility licensed pursuant to Chapter 2 (commencing with section 1250) of Division 2 of the Health and Safety Code, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facility’s policies and procedures.

In addition, a pharmacy can process prescriptions for another pharmacy sharing a common electronic file pursuant to section 1717.1 of title 16 of the California Code of Regulations.

For dangerous drugs other than controlled substances: Two or more pharmacies may establish and use a common electronic file to maintain required dispensing information. Pharmacies using such a common file are not required to transfer prescriptions or information for dispensing purposes between or among pharmacies participating in the same common prescription file.

For controlled substances: To the extent permitted by federal law, two or more pharmacies may establish and use a common electronic file of prescriptions and dispensing information.

(Refer to section 1717.1 of title 16 of the California Code of Regulations for complete requirements.)

Revised June 2025

Ask an Inspector

Medication Guides and Patient Labeling

According to FDA’s Patient Labeling Resources for Industry, available at https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labelingresources#medication-guides (accessed May 21, 2025): The medication guide shall be dispensed to the patient (or to the patient’s agent) in paper form when the product is dispensed; however, the patient may also request electronic delivery of the Medication Guide in lieu of the printed form.

Revised June 2025

Ask an Inspector

Community Pharmacy Staffing Requirements

Business and Professions Code section 4113.5(a) states that a community pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times. See section 1714.3 of title 16 of the California Code of Regulations for additional requirements that apply to community pharmacies that are required to comply with Business and Professions Code section 4113.5.

Business and Professions Code section 4113.6(a) states that a chain community pharmacy subject to Business and Professions Code section 4113.5 shall be staffed at all times with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services. Business and Professions Code section 4113.6(a) further states that the Board shall not take action against a pharmacy for violation of Business and Professions Code section 4113.6 if any of the following conditions apply:

  1. The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
  2. The pharmacy is open beyond normal business hours, which is before 8:00 a.m. and after 7:00 p.m. During the hours before 8:00 a.m. and after 7:00 p.m., the requirement shall not apply.
  3. The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988, or any other ancillary services provided by law, paragraph (3) does not apply.

In addition, per Business and Professions Code section 4113.6(b), where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message.

If you believe a pharmacy is in violation of community pharmacy staffing requirements, you can notify the Board by filing a complaint here. The Board requests the following information be provided:

  • Name and license number of pharmacy
  • Information about how the pharmacy is non-compliant with staffing requirements.

Revised June 2025

Ask an Inspector

Recordkeeping Requirements

Business & Professions Code section 4105(a) states all records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the Board shall be retained on the licensed premises in a readily retrievable form. Business and Professions Code section 4105(d)(1) states any records that are maintained electronically shall be maintained so that the pharmacist-in-charge, or the pharmacist on duty if the pharmacist-in-charge is not on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically. Business and Professions Code section 4105(c) states that the records required by section 4105 shall be retained on the licensed premises for a period of three years from the date of making.

Revised June 2025

Licensees

Mobile Units

A mobile unit is operated as an extension of a pharmacy license held by the county, city and county, or special hospital authority to provide prescription medication within its jurisdiction to individuals without fixed addresses, individuals living in county-owned or city-and-county-owned or operated housing facilities, and those enrolled in Medi-Cal plans operated by the county or a city and county, a health district, or a joint powers authority pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code.

In contrast, a mobile pharmacy is used temporarily when a pharmacy is destroyed or damaged, and the mobile pharmacy is necessary to protect the health and safety of the public, under specified conditions. The Board must approve the temporary use of a mobile pharmacy and the pharmacy operating the mobile pharmacy must provide the Board with records of the destruction of, or damage to, the pharmacy and an expected restoration date of the permanent pharmacy.

A mobile pharmacy can also be employed during a declared federal, state, or local emergency in order to ensure the continuity of patient care, under specified conditions, including that the mobile pharmacy is located within the declared emergency area or affected areas.

(BPC 4062(c), BPC 4110(c), BPC 4110.5)

Revised January 2024

A county, city and county, or special hospital authority may operate one or more mobile units. The pharmacist-in-charge shall determine the number of mobile units that are appropriate for a particular pharmacy license.

(BPC 4110.5)

Revised January 2024

The special hospital authorities that may operate a mobile unit are the Alameda Health System Hospital Authority described in Chapter 5 (commencing with Section 101850) of Part 4 of Division 101 of the Health and Safety Code, and the Kern County Hospital Authority described in Chapter 5.5 (commencing with Section 101852) of Part 4 of Division 101 of the Health and Safety Code.

(BPC 4110.5, HSC 101850, HSC 101852)

Revised January 2024

A county, city and county, or special hospital authority shall notify the Board of its intention to operate a mobile unit as soon as possible, and no later than five business days after commencing operation of a mobile unit. To assist with notification requirements, the Board has developed a form that can be accessed here.

(BPC 4110.5(f))

Revised January 2024

No, only a county, city and county, or special hospital authority described in Chapter 5 (commencing with section 101850) or Chapter 5.5 (commencing with section 101852) of Part 4 of Division 101 of the Health and Safety Code may operate a mobile unit to provide prescription medications.

(BPC 4110.5)

Revised January 2024

No, a mobile unit can only be operated as an extension of a pharmacy license held by a county, city and county, or special hospital authority.

(BPC 4110.5)

Revised January 2024

No, dangerous drugs must not be left in the mobile unit during the hours that the mobile unit is not in operation. The dangerous drugs must be returned to the licensed pharmacy.

(BPC 4110.5(e))

Revised January 2024

Pharmacy law does not specify where the mobile unit is required to be parked. However, during the hours that the mobile unit is not in operation, dangerous drugs cannot be left in the mobile unit. Therefore, the Board recommends the mobile unit be parked at or close to the address of the licensed pharmacy since drugs are required to be stored and secured at the licensed pharmacy operating the mobile unit.

(BPC 4110.5, 16 CCR 1714(b) and (d))

Revised January 2024

Notice of intention to discontinue operation of a mobile unit must be given to the Board ,as soon as possible, and at least one business day before discontinuing operation of a mobile unit.-To assist with notification requirements, the Board has development a form that can be accessed here.

(BPC 4110.5(f))

Revised January 2024

Yes. The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Pharmacy law requires every pharmacy to place the Notice to Consumer poster in a conspicuous place, physically access to a prescription drug consumer, so that the consumer can easily read it. The mobile unit must use the standardized poster provided or made available by the Board, unless the pharmacy has received prior approval of another format or display methodology from the Board. The mobile unit can also display the notice on a video screen located in a place conspicuous to and readable by consumers, subject to specified conditions.

(BPC 4110.5, 16 CCR 1707.6)

Revised January 2024

Yes. The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, the mobile unit must be equipped with a sink with hot and cold running water for pharmaceutical purposes.

(BPC 4110.5, 16 CCR 1714(c))

Revised January 2024

The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. When drugs are stored in the mobile unit, the key to the mobile unit is restricted to a pharmacist. The pharmacy owner (the county, city and county, or the special hospital authority) may possess a key to the mobile unit that is maintained in a tamper evident container for the purpose of 1) delivering the key to a pharmacist or 2) providing access in case of emergency, including fire, flood, or earthquake. The signature of the pharmacist-in-charge must be present in such a way that the pharmacist may readily determine whether the key was removed from the container.

(BPC 4110.5, 16 CCR 1714(d) and (e))

Revised January 2024

No. Methadone is classified as a Schedule II controlled substance and a mobile unit cannot carry or dispense controlled substances, except Schedule III, Schedule IV, or Schedule V controlled substances approved by the United States Food and Drug Administration (FDA) for the treatment of opioid use disorder.

(BPC 4110.5(d), HSC 11055(c)(14))

Revised January 2024

A mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, if the pharmacy operating the mobile unit has a community pharmacy license (PHY or PHE) and only one pharmacist, it must have no more than one pharmacy technician performing the tasks specified in BPC 4115(a). The ratio of pharmacy technicians performing the tasks specified in BPC 4115(a) to any additional pharmacist shall not exceed 2:1, except that this ratio shall not apply to personnel performing clerical functions pursuant to BPC 4116 or 4117.

(BPC 4110.5, BPC 4115(f)(1))

Revised January 2024

Yes. In addition to dispensing prescriptions, the pharmacist may perform activities consistent with Article 3 (commencing with section 4050) of the Business and Professions Code.

(BPC 4110.5(b), BPC 4050-4068)

Revised January 2024

The decision to keep the mobile unit open during the temporary absence of the pharmacist for their duty fee breaks and meal periods resides with the pharmacist working in the mobile unit. The pharmacist may leave the mobile unit temporarily for breaks and meal periods without closing the mobile unit and removing ancillary staff if the pharmacist reasonably believes that the security of the dangerous drugs and devices will be maintained in the pharmacist’s absence.

If the mobile unit remains open during any temporary absence of the pharmacist, no prescription medications may be provided to a patient or patient’s agent unless the prescription medication is a refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist.

During the temporary absence of the pharmacist, an intern pharmacist may not perform any discretionary duties nor otherwise act as a pharmacist. However, the intern pharmacist may perform non-discretionary tasks. Other ancillary staff may also continue to perform the non-discretionary duties authorized to them by Pharmacy Law.

(BPC 4110.5(a), 16 CCR 1714.1, 16 CCR 1793.2)

Revised January 2024

All records required by BPC 4081 and 4105 may be temporarily stored in the mobile unit while it is in operation. At the end of the day, when the mobile unit is not in operation, all records required by BPC 4081 and 4105 must be transferred and maintained on the licensed pharmacy premises that is operating the mobile unit.

(BPC 4110.5, BPC 4081, BPC 4105)

Revised January 2024

Yes, all prescription medication dispensed by the mobile unit must comply with all labeling requirements applicable to a California licensed pharmacy, including all the requirements for patient-centered labeling.

(BPC 4076, BPC 4076.5, 16 CCR 1707.5)

Revised January 2024

Yes. The mobile unit is an extension of a pharmacy license held by a county, city and county, or special hospital authority. Therefore, the duty to consult applies to pharmacists working in mobile units in the same manner as it applies to pharmacists working in any other pharmacy.

(BPC 4110.5, 16 CCR 1707.2)

Revised January 2024

Yes, the pharmacist is still responsible to provide patient consultation pursuant to 16 CCR 1707.2.

(BPC 4110.5, 16 CCR 1707.2)

Revised January 2024

Yes. Inspectors employed by the Board (or by the Division of Investigation of the Department of Consumer Affairs) may inspect during business hours all pharmacies or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.

(BPC 4008)

Revised January 2024

The mobile unit is operated as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, the mobile unit is required to maintain its facilities, space, fixtures, and equipment so that drugs are safely and properly prepared, maintained, secured, and distributed. Further, the mobile unit and fixtures and equipment must be maintained in a clean and orderly condition, and the mobile unit must be dry, well-ventilated, free from rodents and insects, and properly lighted.

Each pharmacist while on duty in the mobile unit is responsible for the security of prescription drugs in the mobile unit, including provisions for effective control against theft or diversion of dangerous drugs and devices, and records for such drugs and devices.

(16 CCR 1714)

Revised January 2024

Mobile units can only carry and dispense Schedule III, Schedule IV, or Schedule V controlled substances approved by the FDA for the treatment of opioid use disorder.

(BPC 4110.5(d))

Revised January 2024

Any Schedule III, Schedule IV, or Schedule V controlled substance approved by the FDA for the treatment of opioid use disorder shall be carried in reasonable quantities based on prescription volume and stored securely in the mobile pharmacy unit.

(BPC 4110.5(d)(2))

Revised January 2024

Yes. Naltrexone is not a federally scheduled controlled substance. Currently, there is no prohibition, against a mobile unit carrying or dispensing this drug.

(BPC 4110.5)

Revised January 2024

Yes.

(HSC 11165 (d))

Revised January 2024

Licensees

Patient Specific Prescriptions Dispensed by a California Licensed Outsourcing Facility within or into California

A statute effective January 1, 2022, allows for California licensed outsourcing facilities to dispense patient specific prescriptions. To qualify, an outsourcing facility must: 1) be licensed with the federal Food and Drug Administration as an outsourcing facility; 2) be licensed with the Board of Pharmacy in the State of California as a resident or nonresident outsourcing facility; and 3) comply with same requirements of a pharmacy when dispensing patient-specific prescriptions. The purpose of these FAQs is to generally describe the requirements under California law governing patient-specific dispensing by licensed outsourcing facilities. For a full understanding of the requirements, please read the cited sections of California Pharmacy Law.

A California licensed outsourcing facility, when dispensing patient-specific prescriptions in or into California, will need to comply with California law governing the dispensing of patientspecific prescriptions that a pharmacy would have to comply with including, but not limited to, the duty to provide consultation, requirements regarding prior review of drug therapy and labeling of prescriptions and other miscellaneous requirements.

References to BPC refers to California’s Business and Professions Code, references to HSC refers to California’s Health and Safety Code, references to CCR refers to sections of Title 16 of the California Code of Regulations, and references to CFR refers to sections of Title 21 of the Code of Federal Regulations. Additionally, the provisions of law can be found on the Board’s website.

Yes, under specified conditions including:

  1. upon request;
  2. whenever the pharmacist deems it warranted in the exercise of their professional judgment;
  3. whenever the prescription drug has not previously been dispensed to a patient;
  4. whenever a prescription drug not previously dispensed to a patient in the same dosage form, strength or with the same written directions, is dispensed.

Note: The pharmacist must review a patient’s drug therapy and medication record prior to consultation. Further, consultation must be performed in a manner suitable for patient confidentiality (Civil Code 56.10, CCR 1714(a), 1764)).

Reference: CCR sections 1707.2 & 1707.3

Revised January 2022

BPC sections 4040 and 4070 detail the required information on the prescription.

Revised January 2022

  • Effective January 1, 2022, most prescriptions must be sent and received electronically subject to certain exemptions. The Board has FAQs available that provide further information on those requirements.
  • Prescriptions that are orally transmitted can only be received and reduced to writing by a pharmacist or a pharmacist intern, working under the direct supervision of a pharmacist.
  • A faxed or electronically submitted prescription must be received only from a prescriber’s office unless otherwise provided in the law.

Note: Records must include identification of the pharmacist and be retained for a period of three years.

Reference: BPC 688, 4040, 4070, 4071 and CCR 1712, 1717

Revised January 2022

Yes, under specified conditions. The prescriptions must be comply with Division 10, Chapter 4 of the HSC. [Add link]. Prescriptions must be on forms with certain security features as specified in this chapter. Also, California law imposes a duty of corresponding responsibility on pharmacists who dispense a controlled substance that it is issued for a legitimate medical purpose.

Note: Controlled substances prescriptions are valid for a limited period of time and have additional requirements if e-prescribed.

Reference: HSC sections 11153, 11159.2, 11159.3, 11162.1, HSC 11164(a), 11166, 21 CFR 1306.08, 1306.11, 1311.100

Revised January 2022

Yes. Requirements for prescription labeling are established in provisions of state and federal law described below.

  • The prescription label must contain all the required information established in BPC section 4076, the prescription label must be formatted in accordance with patientcentered labeling requirements. Also, the expiration date of a drug’s effectiveness must be accurately identified on the label. (Reference: BPC 4076 and CCR 1707.5.)
  • The trade name or generic name and manufacturer of the prescription drug must be accurately identified on the label and prescription record and includes the statement “generic for _____” where the brand name is inserted, and the name of the manufacturer. In the professional judgment of the pharmacist, if the brand name is no longer widely used, the label may list only the generic name of the drug and the manufacturer’s name may be listed outside the patient-centered area. (Reference: BPC 4076, CCR 1717[b][2], CCR 1707.5[a][1][B])
  • The federal warning label prohibiting transfer of controlled substances must be on the prescription container. (Reference: 21 CFR section 290.5)
  • If the prescription is filled by a pharmacy technician or a pharmacy technician trainee, before dispensing, the prescription must be checked for accuracy by a pharmacist and that pharmacist must initials the prescription label or records by their identity as the reviewing pharmacist in a computer system by a secure means. (Reference: BPC 4115, 4115.5, CCR 1793.7, CCR 1712)
  • Prescriptions must be dispensed in a new and child-resistant container, or senior-adult ease-of-opening tested container, or in a non-complying package only pursuant to the prescriber or when requested by the purchaser. (Reference: 15 USC section 1473[b], 16 CFR section 1700.15, CCR section 1717)
  • The label must include a physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. (Reference: BPC 4076)

(BPC 4110.5)

Revised January 2022

Yes

  • Patient package inserts must be dispensed with all estrogen medications. (Reference: 21 CFR section 310.515)
  • The pharmacy must provide patients with Black Box Warning Information in conformance with 21 CFR section 201.57[c].
  • Medication guides must be provided on required medications. (Reference: 21 CFR, Part 208, Section 208.24[e])
  • The drug container must contain a written label indicating that the drug may impair a person’s ability to operate a vehicle or vessel. The label may be printed on an auxiliary label affixed to the prescription container. (Reference: BPC 4074, 4076.7, and CCR 1744)
  • The written label on the drug container must alert the patient about possible potentiating effects when taken in combination with alcohol. The label may be printed on an auxiliary label affixed to the prescription container. (Reference: BPC 4074, CCR 1744)
  • Whenever an opioid prescription drug is dispensed to patient for outpatient use, the label or container must contain a flag or other notification on the container, with a notice that states, “Caution: Opioid. Risk of overdose and addiction.” (Reference: BPC 4076.7)
  • No drug preparation may be compounded prior to receipt by the outsourcing facility of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug preparation either orally or in writing. Where approval is given orally by the prescriber, that approval shall be noted on the prescription prior to compounding. There are two exceptions to this prohibition of prior compounding of a drug preparation of: 1) a limited quantity to ensure continuity of care for an identified population of patients of the outsourcing facility based on a documented history of prescriptions for that patient population; and 2) a reasonable quantity that may be compounded for prescriber office use as authorized by BPC section 4052(a)(1). (Reference: CCR 1735.2).

Revised January 2022

No, generally prescriptions for non-controlled substances can be filled for more than the prescription allows; however, there are several exceptions. Please see the referenced law section for more information about the specific provisions conditions.

Reference: BPC 4064.5

Revised January 2022

Yes, there are limits. Requirements vary based on the schedule.

Reference: HSC 11200

Revised January 2022

  • Refill authorization from the prescriber must be obtained before refilling a prescription (BPC section 4063) and refills must be documented. (Reference: CCR 1717).
  • Refills for Schedule II controlled substances are prohibited. (Reference: HSC 11200)
  • Refills for Schedule III and IV controlled substance prescriptions are limited to a maximum of 5 times within 6 months, and all refills taken together may not exceed a 120-day supply. (Reference: HSC 11200)

Note: Effective July 1, 2022, Board regulations established parameters for automatic refill programs generally related to obtaining informed patient consent to enroll in such programs and how to withdraw from such programs.

Revised January 2022

Yes, a quality assurance process is necessary to meet the requirements of California Law.

Reference: BPC 4125, CCR 1711

Revised January 2022

Yes, a pharmacist must fulfill their corresponding responsibility.

Note: The Board has issued a precedential decision on this point, the Pacifica Pharmacy matter, which can be found on the Board’s website in addition to educational information and a video on corresponding responsibility.

Reference: HSC 11153, CCR 1761

Revised January 2022

Yes, schedule II-V controlled substances must be reported to the CURES system.

Note: The Board has information on the CURES system on its website, including how to register for access to the CURES system.

Reference: HSC 11165, 21 CFR 1308.12, 1308.13, 1308.14, 11308.15

Revised January 2022

Yes. There is no express prohibition against advertising per se. See Business and Professions Code section 17500.1. However, false and misleading advertising by any licensee of the Board could constitute violations of BPC sections 17500, 651 and 4301. Also, California law regulates different arrangements including rebates and referrals and you should consult California law, including but not limited to, BPC sections 650 through 657 in structuring arrangements to ensure compliance with California law.

Reference: BPC 650, 4301, 17500 and CCR 1766

Revised January 2022

Yes. The Board of Pharmacy has adopted self-assessment forms to assist pharmacists in maintaining compliance with Pharmacy Law. Review of the form may provide additional information and guidance on requirements for dispensing prescriptions to California patients.

Revised January 2022

Licensees

License Renewal Applications: Reporting Criminal Convictions/Disciplinary Action

Yes, if it occurred during your last renewal. For the purposes of completing the renewal application, a criminal conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. This includes misdemeanors and felonies.

Yes. Criminal convictions in another state or in United States District Court must be reported if they occurred during your last renewal period.

Yes.

A written statement, arrest report, court documents, and proof of compliance with courtordered probation.

Traffic infractions not involving alcohol, dangerous drugs, or controlled substances do not need to be reported.

Yes. If you renew by mail, please provide a copy of the citation/fine letter or Letter of Admonishment in addition to the renewal application. If you no longer have this documentation, please provide a written statement including the conviction date, court location, and conviction charges.

The Department of Consumer Affairs automatically sends a letter to licensees who mark ”Yes” to the criminal conviction question on their online renewal application. You may disregard this notice if you have already provided the requested documents to the board.

No. You may voluntarily report this information to the board, but it is not required. Please contact enfappreview@dca.ca.gov if you have further questions.

No. Suspension against a driver’s license does not need to be reported on a renewal application.

The California Board of Pharmacy is a consumer protection agency that is mandated to conduct investigations on all licensees with criminal history pursuant to Business and Professions Code section 4301.

For the purposes of a renewal application, “formal disciplinary action” means an adverse action that resulted in a restriction or penalty being placed on the license, such as revocation, suspension, probation or public reprimand or reproval.

Yes. If your license was placed on probation or issued a letter of public reprimand or reproval, please provide your administrative case number along with your renewal application.

No. If the citation and fine was issued for a non-criminal matter, it does not need to be reported on the renewal application.

If formal disciplinary action was taken against your professional license in another state, it must be reported on your renewal application.

Please provide the charging document (ex: Accusation, Complaint, etc.) and any final documents showing the case outcome (ex: Settlement Agreement, Consent Order, etc.).

For questions regarding reporting criminal convictions or formal disciplinary action on a renewal application, please contact enfappreview@dca.ca.gov. For general questions regarding renewals, please contact renewalstatus@dca.ca.gov.

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