The Drug Quality and Security Act, or DQSA, gave the FDA
increased authority over compounding pharmacies, and the agency has responded
by trying to regulate compounded drugs and supplements out of existence. Access to these compounded drugs is a life-and-death issue
for many people, and the FDA's treatment of compounding puts millions of people
Click below to take action. Tell Congress and the FDA to preserve consumer access to compounded medications.
Please preserve access to compounded medicines
Dear [Decision Maker],
The Drug Quality and Security Act, or DQSA, gave the FDA increased authority over compounding pharmacies, and the agency has responded by trying to regulate compounded drugs and supplements out of existence. Access to these compounded drugs is a life-and-death issue for many people, and the FDA's treatment of compounding put millions of people at risk. Here is what is at stake:*Bioidentical estriol in particular, but also testosterone, estradiol and progesterone, are currently all at risk. The danger is that the FDA will arbitrarily and nonsensically find them "too difficult to compound," despite their having been compounded for decades. In addition to bioidentical hormones, delivery systems such as time release capsules have also been nominated to the "difficult to compound" list -- threatening, for example, time-release thyroid drugs. The FDA has separately proposed to eliminate public participation from the determination process, so this would illegally occur behind closed doors with no recourse. *Compounded IV treatments are also at risk. These are doctors' drips of critical nutrients (including even the most common vitamins, e.g. C and B and minerals) into the patient's blood, and are essential for many, many ailing patients. IV glutathione, one of the bodies most important defenses against disease, could be rejected for various technical reasons--it is not a component of an FDA-approved drug and has no USP monograph, so it's very uncertain whether FDA will add it to the bulk drug list. *IV vitamins, minerals, and other nutrients (considered drugs when used in an IV) are already less accessible and much more expensive because office use (see below) is no longer permitted. Interstate shipment limitations reduce access to all drugs. Since IVs are rarely paid for by insurance companies, making them prohibitively expensive is yet another indirect way to ban them, despite their proven medical value.*All compounded dietary supplements must be pre-approved, with one potential exception -- unless it is a component of an approved drug. This exception, if even recognized, would apply to very few supplements. Note further that no one has submitted a comprehensive list of supplements to the FDA to review. Those submitted have mostly been denied thus far. At this point, doctors are afraid to submit more since they will just be rejected.*Compounded chelation drugs are also threatened. Ironically a controversial government-run study recently reaffirmed chelation's effectiveness for heart disease and other problems, much to the dismay of conventional medicine critics and Big Pharma companies.*Separately, insurance companies have stopped paying for many compounded drugs, further reducing demand. There are other threats, too. The agency's new guidance, "Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act," 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."But 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? Because of the other stringent regulations being passed on 503A facilities such as the banning of office use, tight restrictions on interstate commerce, as well as the agency's unwillingness to approve safe, natural ingredients to the Bulk Drugs list such as curcumin, aloe vera, and boswellia, it is going to be increasingly difficult for 503A facilities to stay in business. This guidance is yet another nail in the coffin. If traditional pharmacies shut their doors, how will consumers get the medicines they rely on?Compounded medications are a lifeline for so many Americans. It is vital that neither the FDA nor the pharmaceutical industry is allowed to regulate compounded drugs and supplements to death and remove them from the market. I urge Congress to act decisively to ensure my continued access to compounded medicines. I urge the FDA to relent on its multiple attacks against the industry.
Sincerely,[Your Name] [Your Address] [City, State ZIP]