Use of PPE in Certain Compounding Aseptic Isolators or Compounding Aseptic Containment Isolators (Title 16, California Code of Regulations, section 1751.5)
Provisions of Title 16, California Code of Regulations, section 1751.5(a)(1)-(3) related to the requirement to don PPE garb (including masks, gowns, head, and shoe covers) when compounding in a compounding aseptic isolator or compounding aseptic containment isolator May be waived under the following conditions:
- The pharmacist-in-charge has made a determination that the current and potential stock of PPE on hand is insufficient to maintain garbing requirements established in the regulation.
- The isolator manufacturer has provided written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This documentation must be readily retrievable by the licensed location.
- A policy is developed that details the revised conditions for use of PPE for compounding pursuant to this waiver.
- Applicable pharmacy staff are trained on the policy and the training is documented prior to implementation.
- Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
- Surface sampling schedule will be reviewed for the possible need to increase the frequency.
- Documentation indicating the duration of time the pharmacy is operating under the waiver approval is maintained.
Note: This waiver not does extend to the requirements for the use of sterile gloves.
Effective: April 1, 2020
Expiration: December 28, 2020