ANH members played a key role in thwarting efforts to eliminate access to personalized medicine.
Two years ago, the FDA released a draft guidance saying that a compounding pharmacy (a pharmacy that makes customized medicines for individual patients) cannot register as both an “outsourcing” (503B) and a traditional (503A) facility. We issued an action alert to ANH members to speak out against this policy and submitted detailed legal comments drafted by our general counsel. The agency just released the final guidance, and the FDA listened to our criticisms. The bottom line is that this change will make it much easier for many compounding pharmacies to stay in business, meaning patients will be better able to get the medicines, such as nutrient IV infusions and bioidentical hormones like progesterone and estriol, that they need.
This is an important victory. The Drug Quality and Security Act of 2013 (DQSA) separated compounding pharmacies into two categories:
- “traditional” compounding pharmacies (regulated under section 503A of the Food, Drug, and Cosmetic Act), and
- “outsourcing” compounding pharmacies (regulated under section 503B of the same law).
Among the main differences between these two pharmacies are that outsourcing pharmacies can engage in office use compounding (making medicines for doctors to keep on-hand in their offices), and can ship medicines interstate without restriction, but they can only compound substances from a limited, preapproved list from the FDA. It is already clear that the FDA intends this medications list to be very short. Because outsourcing facilities can compound for office use and ship interstate, they are well-placed to capture a large portion of the market—even if they can only compound from a shorter list of medications.
Traditional pharmacies can no longer engage in office use, and can only ship between 5% and 30% of total orders out-of-state, but they are able to make many medications that outsourcing facilities cannot. Specifically, they can compound medications that have a USP monograph, are components of approved drugs, or are on a preapproved list. For example, the bioidentical hormone estriol is, as of yet, not included on a preapproved list for outsourcing facilities to compound, and we believe it unlikely to be added; however, because it has a USP monograph, traditional pharmacies can make it. (Note that special interests are attempting to ban estriol through another process, and we are fighting them every step of the way.)
Remember that the FDA is funded by drug companies, not pharmacies, and drug companies see compounded medicine as competition and a threat to their bottom line. It seems to us no surprise then that the FDA policies of limiting office use and interstate sales would first pressure traditional pharmacies to register as outsourcing facilities, where the FDA can decide what medications can be made. Second, FDA’s latest proposal would have eliminated their ability to still provide medications they can make as a 503A traditional pharmacy. They would have been forced to choose: switch to an outsourcing facility where the FDA is more in control, or remain a traditional pharmacy and potentially go out of business.
We’re glad that the FDA has changed course and will allow pharmacies the flexibility to compound as both outsourcing and traditional facilities. Unless the FDA has something else up its sleeve, this change in course will help many pharmacies keep their doors open. We must continue to hold the agency’s feet to the fire to prevent even more damage to the compounding industry!