What Do We Know About Compounding Pharmacies?

By: Amy VanDeCar, CIS Compliance Manager
amyvandecar@cis-partners.com

On a recent trip to New Jersey and Pennsylvania, I was struck by a series of ads on satellite radio for “quick dissolve” versions of some very popular prescription medicines. Having previously worked for branded and generic manufacturers, I have some knowledge of the time, expense and effort involved in securing approval for a new drug. In listening to the ads, however, I realized that I don’t know what the rules are for compounding pharmacies. Do they have an approval process similar to what generic manufacturers go through in submitting an ANDA? Are they exempt from this process because they are simply modifying an approved, branded product? Or, am I correct to question the legitimacy of the products being advertised?

To find out, I began by performing an internet search for “compounding pharmacies.” The first site that came up was the very official-looking “IACP – International Academy of Compounding Pharmacists” site.[i] According to the site, IACP’s mission is ‘to promote and advance personalized medical solutions’ for people whose healthcare needs cannot be met by off-the-shelf medications. The site explains that “trained, licensed pharmacists… work with physicians, nurse practitioners and veterinarians to create customized medication solutions.” That sounds good, but doesn’t tell me much about the rules under which the compounding pharmacies operate.

Continuing my search, I found a site for the Pharmacy Compounding Accreditation Board.[ii] This site provided more information about the legal basis and boundaries for compounding pharmacies. Apparently, compounding activities fall under the regulation and oversight of state boards of pharmacy. Compounding may be conducted for use in physician offices or in anticipation of routine prescription orders. Quantities, in the later case, are limited to “reasonable quantities,” though that is not defined on the PCAB site. Compounding activities may not duplicate commercially available products, but may modify existing products by changing the strength, delivery mechanism or dosage form, or by removing dyes. While this provided some general guidelines, it did not answer the question of the regulatory basis for compounding activities.

Next, I turned to the US Pharmacopeia (USP) site, where I found a white paper[iii] describing “non-governmental and governmental approaches to provide compounding standards and conformity assessment to these standards.” From this, I learned that the question of whether compounded drug products constitute “new drugs,” subject to all of the corresponding regulations, remains unanswered, as does the legality of advertising compounded drugs, though the most recent rulings on the matter leave the door open for advertising these products. The site confirms that the practice of compounding is regulated by state boards of pharmacy. USP notes that while this has translated into considerable variance in regulations, NABP has provided template language for use in developing rules.

Turning finally to the FDA website, I confirmed that the FDA typically defers to states in the regulation of compounding activities. However, the FDA retains the authority to proceed without the states. The FDA has identified factors triggering federal enforcement as “instances where pharmacists are:

• Compounding drug products that have been pulled from the market because they were found to be unsafe or ineffective.
• Compounding drugs that are essentially copies of a commercially available drug product.
• Compounding drugs in advance of receiving prescriptions, except in very limited quantities relating to the amounts of drugs previously compounded based on valid prescriptions.
• Compounding finished drugs from bulk active ingredients that aren't components of FDA-approved drugs, without an FDA-sanctioned, investigational new-drug application.
• Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
• Failing to conform to applicable state law regulating the practice of pharmacy.”[iv]

While the organizations discussed above have laid down a few do's and don'ts for pharmaceutical compounding, the practice still remains largely regulated by state boards of pharmacy. For more information, please check out the following sources.

Sources:
[i] http://www.iacprx.org/site/PageServer?pagename=home_page
[ii] http://www.pcab.info/
[iii] http://www.usp.org/pdf/EN/members/goodMedicine.pdf
[iv]http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm, see “Red Flags”