Maintaining Compliance in Pharmacy Compounding: Regulatory & Enforcement Updates

There have been significant changes in pharmacy compounding regulations since 2013. This program will address these changes and help attorneys keep their pharmacy clients compliant with Section 503A of the Federal Food Drug, and Cosmetic Act, as well as the various federal and state statutes, regulations, and guidance addressing compounding. Taught by Karla Palmer, Director at Hyman, Phelps & McNamara, P.C., the program will also address enforcement activities concerning compounding.

This program will benefit lawyers that advise pharmacy compounders, pharmacies, pharmacists, and owners of outsourcing facilities.

1. Review exactly what pharmacy compounding is and how it is regulated by states and the federal government
2. Analyze the current regulatory environment for compounders and how to effectively represent pharmacies that engage in this highly regulated area
3. Discuss guidance documents and regulations, and what is forthcoming in 2021
4. Anticipate what compounders can expect when facing regulatory activity, including pharmacy inspections