Revamping pharmacies for public safety and compliance

The United States Pharmacopeia's (USP's) Chapter 800 Pharmaceutical Compounding—Sterile Preparations becomes effective in December 2019. Many pharmacies in the United States will need to upgrade their facilities before that date to meet these new guidelines, and HMC Architects recommends three steps to help ensure compliance.

The United States Pharmacopeia's (USP's) Chapter 800 Pharmaceutical Compounding—Sterile Preparations becomes effective in December 2019. Many pharmacies in the United States will need to upgrade their facilities before that date to meet these new guidelines, and HMC Architects recommends three steps to help ensure compliance. First, designate a project design team early in the evaluation process. This should include an owner representative; pharmacist; architect; mechanical, electrical, and plumbing engineers; security consultant; equipment specialist; contractor; and cost estimator to establish a realistic project budget. Second, plan for temporary licensed facilities. If in California, obtain California Department of Public Health (CDPH) approval through the Office of Statewide Health Planning and Development (OSHPD) of the functional program during the OSHPD preliminary review. Establish a realistic project timeline that includes construction and licensing of temporary facilities, and have the project design team examine existing facilities and write a report of what is needed to achieve compliance with USP 797/800. Finally, meet and communicate weekly. Invite the OSHPD inspector to regular project team meetings, suggest submitting one-half of construction documents for preliminary review, and discuss project timelines frequently with the project team. Construction duration of 6 months, especially during influenza season, is recommended.