The FDA has released another guidance on yet another seemingly technical matter that would put traditional compounding pharmacies in even greater jeopardy.The Drug Quality and Security Act of 2013 (DQSA) separated pharmacies that make customized medicines at a doctor’s direction for individual patients 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).In a nutshell, the new guidance says that a pharmacy cannot register as both a traditional and an outsourcing facility. The stated rationale is that outsourcing facilities must follow stringent current good manufacturing practices (cGMPs) while traditional pharmacies do not—and if one facility has both a 503A and a 503B operation, it will be “difficult to ensure that all of the products were made under the correct standards.”It will be evident that this purported justification is a complete sham. Where would the difficulty be in having one division of a facility compound drugs under one set of rules, and having another division of the same facility compound medicines under a different set of rules? Such an arbitrary ruling further strengthens our contention that this is part of a larger campaign by the FDA to eliminate traditional pharmacies altogether, since they compete with the pharmaceutical industry, which pays the FDA’s bills.The FDA’s real goal with this guidance, and many other restrictions on the industry, is to get all traditional facilities to register as outsourcing facilities, since what can be compounded at outsourcing facilities is completely at the FDA’s whim and can be very narrowly defined. This will likely eliminate many traditional compounding pharmacies altogether, and leave only the largest companies open for business—and those can be expected to be owned by Big Pharma.Tell the FDA to amend this guidance to allow 503A facilities to register also as 503B outsourcing facilities, so traditional pharmacies can have both kinds of businesses under the same roof.
Please amend the definition for 503B compounding facilities
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]