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Bio-Identical Hormones ‘Out of Business’ Sign Going Up?

Bio-Identical Hormones ‘Out of Business’ Sign Going Up?
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If there are no pharmacies selling, you won’t be able to buy it. Action Alert!
Last week we told you about the recent guidance from the FDA that ignores directives from Congress and continues to ban office use by doctors of prepared medications such as injectable vitamin B12—while carving out a potentially lucrative exemption for hospital pharmacies.
Unfortunately, the bad news doesn’t stop there. 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).

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), can ship medicines interstate without restriction (traditional pharmacies can only ship 5% of total orders out-of-state, unless the state enters into a memorandum of understanding), and can only compound substances from a preapproved list from the FDA. It is already clear that the FDA intends this medications list to be very short indeed. 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 ingredients.
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.
Thus far, the FDA has been accomplishing its goal of eliminating compounding by making it impossible for traditional pharmacies to stay in business by restricting what medicines they can make and how much they can ship out of state, and by eliminating office use.
Before this new ruling, one possible way to continue to make the medicines that integrative doctors and countless patients rely upon was to register as both a 503B and a 503A pharmacy. But with this guidance, the FDA has now eliminated that possibility—another nail in the coffin for traditional pharmacies.
The FDA clearly does not feel responsible to the public. If it did, it might take heed of Congress’s repeated warnings that the agency is going too far in its implementation of DQSA, a bill Congress intended as a tool to regulate—not abolish!—compounding pharmacies.
Action Alert! Write to the FDA and urge them to amend this guidance and preserve consumer access to natural medicines by allowing 503A facilities to register also as 503B facilities. Please send your message immediately.
Additional Action Alert! If you haven’t already, write to your representative in the House and urge him or her to support the FY 2017 appropriations language that would withhold funding from the FDA until the agency states how it will allow “office use” of compounded medicines to continue, and how the overall compounding of supplements and medications will move forward and at reasonable prices. Please send your message immediately.

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