Presidential Viewpoint BY MICHAEL JACKSON, RPH DANIEL E. BUFFINGTON, PHARMD, MBA, FAPHA ALYSON LOZICKI NELSON, PHARMD ALEX PYTLARZ, PHARMD
T
FDA Retreated from Their Attempts to Overregulate Compounding Pharmacies
he US Food and Drug Administration’s mission and purpose are to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and to ensure the safety of our nation's food supply, cosmetics, and products that emit radiation. They are not responsible for regulating health care practice standards or the pharmacy marketplace. However, for the past few years, they have attempted to regulate pharmacy business practices in states and dictate changes to their respective boards of pharmacy. This is most apparent with their attempt to force a “memorandum of understanding” or MOU that exerts limits and tracking of interstate sales of compounded medications.
years of dialogue and stakeholder input. The MOU was finally published disseminated to states in October of 2020 and boards of pharmacy were given 365 days to decide to enter. This document is directed specifically at 503A compounding pharmacies. Each state board of pharmacy or governing body was given the option to sign the MOU, which was designed to track the compounding pharmacies that shipped high volumes of compounded medications across state lines. The purpose of the MOU was to establish an agreement between a state’s board of pharmacy, or other appropriate state agencies, and the FDA to monitor the interstate distribution of inordinate amounts of compounded human drug products. It also aimed to opti-
Daniel E. Buffington, PharmD, MBA, FAPhA
This process started with an article originally drafted in 1997 and was initially named the “Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the US FDA”, currently referred to as the FDA Memorandum of Understanding (MOU). The MOU was created with consultation from the National Association of Boards of Pharmacy (NABP), Food, Drug, and Cosmetic Act, and nearly 20 MARCH 2022
|
5
