USP <797> Requirements Related to Use of Personal Protective Equipment (BPC section 4126.8)

Waive USP <797> requirements related to the use of personal protective equipment (PPE) as related to Business and Professions Code section 4126.8, in that a PPE mask and gown may be reused by staff performing sterile compounding 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 the single-use provisions established in USP <797>.
• The pharmacy has developed a policy that details the conditions under which PPE may be reused.  Such policies shall be consistent with standards of practice used during emergency situations.
• Documented training on the policy is provided to all staff.
• Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
• Surface sampling schedule was reviewed for the possible need to increase the frequency.
• Documentation is maintained indicating the duration of time the pharmacy is operating under the waiver approval.

Effective:  March 17, 2020

Expiration:  May 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.