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Will the FDA Close Your Pharmacy?

Will the FDA Close Your Pharmacy?

It may come to that if a key policy isn’t changed. Action Alert!

As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA issued a revision of a bad policy that will limit the amount of medicines compounding pharmacies can send out of state. The revision offers some improvements, but still makes it harder for patients to get the medicines they need. This benefits Big Pharma at the expense of the consumer.

The rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into a Memorandum of Understanding (MOU) permitting additional sales.  In exchange, however, the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states.

Previously, pharmacies in states that signed the MOU could send 30% of their sales interstate, but the FDA has increased that number to 50%. In an earlier proposal in 1999, the number was 20%. It is good that the number has increased, but these changes also highlight the arbitrary nature of this process. Why not 60%, or 80%? Why include any limit?  Does the FDA know what it’s doing at all?

Importantly, the revised MOU does not address a key issue, which is that it shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.

Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. If that pharmacy is in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50% of their sales out-of-state, you’d be out of luck.

Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.

All of this is happening simultaneously to the FDA threatening to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s “Difficult to Compound List”; items that appear on the final list will not be able to be compounded at all. You can consult our previous coverage for more details.

As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We have to fight back and ensure that patients can get the medicines they need.

Action Alert! Write to FDA with a copy to Congress, telling them to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please send your message immediately.

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