Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA

A review of the requirements for pharmacies considering ordering compounds from a 503B facility.

Twenty states proposed bills to prohibit white bagging and brown bagging policies this year.

Launching development of SOPs and communication with wholesalers is key.

The FDA’s temporary Guidance for 503A compounding of shortage drugs was meant to be temporary and withdrawn once COVID-19 ended.

Part 1 of this 2-part series examines USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA.