In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened federal control over compounding pharmacies.
To implement the law, the FDA is setting guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities).
· 503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized. Current thinking is that this list will be extremely limited in terms of the needs of integrative physicians.
· 503A pharmacies are also facing harsh restrictions. DQSA rules limit the substances that can be compounded by traditional pharmacies to those that either 1) have US Pharmacopoeia monographs, 2) are components of approved drugs, or 3) appear on a pre-approved list by the FDA. The FDA is developing a separate “Demonstrably Difficult to Compound List” that will exclude many other important ingredients from compounding.
What is threatened?
Bioidentical Hormones—Estriol, progesterone, testosterone, and other hormones have been nominated to the “Demonstrably Difficult to Compound” list, meaning that access to compounded hormones is in grave danger.
Supplements—Although many supplements have USP monographs, the FDA has stated that supplements must be pre-approved to be legally compounded. Many supplements and natural ingredients that have been nominated have been rejected, such as curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
IV Nutrients—It is unclear whether the FDA will allow the compounding of nutrient IV bags—especially due to the threats to compounded supplements.
Office Use— The FDA has made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.
Affordability—Due to the above-mentioned restrictions, and the threat of more to come, it has become extremely difficult for doctors to obtain medications. For example, the price of injectable B-12 has climbed just under 700% from the mid-2000’s.
Interstate Commerce—DQSA limits the amount of interstate shipments that 503A facilities can make to 5% of total sales. This is extremely problematic given that certain pharmacies specialize in specific preparations. A memorandum of understanding released by the FDA increases this amount to 30%, but then states must take over regulatory responsibility over these facilities. Since it is likely that many states will not elect to take on this additional burden, the upshot is 503A facilities will only be able to ship a small portion of their medications out of state, which could create shortages and increase the price of compounded medications further.
What Can You Do?
· Follow the developments regarding compounding at ANH-USA.org.
· Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to compounded medications.
· Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/
· Support ANH-USA in its efforts to rein in these excessive, burdensome, and costly regulations at http://www.anh-usa.org/donate/