Sterile Compounding/Nonresident Sterile Compounding/Hospital In-Patient Sterile Compounding Pharmacy License
A pharmacy shall not compound sterile drug products for injection, administration into the eye, or inhalation unless the pharmacy has obtained a sterile compounding pharmacy license issued by the board. The licenses are renewed annually and are not transferrable. The pharmacy must comply with all laws and regulations regarding drug recalls.
A sterile compounding pharmacy license can be issued only to a location that is currently licensed with the board as a pharmacy or a non-resident pharmacy. The board will not issue or renew a sterile compounding license until the location has been inspected by the board and is found to be in compliance with all laws and regulations adopted by the board.
Article 7.5 of the Business and Professions Code (starting with section 4127) specifies requirements for sterile compounding pharmacies. Likewise, board regulations specify additional requirements for compounding and for sterile compounding (Title 16 California Code of Regulations, section 1735 et seq. and section 1751 et seq.).
A nonresident pharmacy shall reimburse the board for the cost of inspection before the license will be issued.
If a nonresident pharmacy is shipping compounded sterile drug products into California, this pharmacy must:
- Be licensed as a nonresident pharmacy
- Be separately licensed with the board as a nonresident sterile compounding pharmacy, AND
- Comply with board regulations for sterile compounding
ApplicationThe board may require additional documentation to confirm or substantiate the ownership structure reported at any time during the application process.
- Sterile Compounding License Application
- Nonresident Sterile Compounding License Application
- Hospital In-Patient Sterile Compounding License Application