Use of Sterile Disinfectant Agents – Title 16, California Code of Regulations, section 1751.4(d)(1)

Waiver of Title 16, California Code of Regulations, section 1751.4(d)(1) to allow for the use of a non-sterile alcohol-based disinfectant after cleaning on work table surfaces, carts, and counters under the following conditions:

1. The pharmacist-in-charge has made a determination that the current and potential stock of sterile alcohol (sIPA) on hand is insufficient to maintain the requirements established in the regulation.
2. The surface or equipment is NOT contained within an ISO Class 5 environment.
3. Surface sampling schedule is reviewed for the possible need to increase the frequency of cleaning and disinfection.
4. Documentation indicating the duration of time the pharmacy is operating under this waiver is maintained.

Effective: April 3, 2020

Expiration: July 1, 2020