Practitioners Take Huge Risks Dealing With Rogue Drug Compounders

December 2017 | Volume 16 | Issue 12 | Editorials | 1308 | Copyright © December 2017

Sheldon Bradshaw JD

FDA and Life Sciences Practice Group, King & Spalding,Washington, DC

Medical practitioners in general (and ophthalmologists, dermatologists, and plastic surgeons in particular) are increasingly being approached by entities who mass manufacture drugs – under the guise of compounding – that they claim are lower-cost or more convenient alternatives to the FDA-approved drugs the practitioners are already administering or dispensing in their practices. These entities often promise that their products will yield higher profits for practitioners than the FDA-approved alternatives. In some cases they are even offering to help practitioners compound their own special blends of drugs right in their offices or clinics.But let the buyer beware. Entities making such claims are typically not engaged in lawful drug compounding. Indeed, the rogue actors are neither engaged in the time-honored practice of traditional pharmacy compounding (where a pharmacist, pursuant to a prescription, prepares a drug product that is tailored to the medical needs of a specific patient), nor engaged in the well-accepted practice of compounding medically necessary therapies that are currently unavailable in the marketplace. Rather, they are brazenly circumventing FDA’s drug manufacturing and compounding laws to increase their own profits and, in doing so, they put both patients and practitioners at risk.This paper is intended to: (1) provide background on the laws related to legal compounding, (2) summarize the risks to patients and practitioners provided by rogue actors manufacturing drugs under the guise of lawful compounding, and (3) provide concrete steps that practitioners can easily undertake to protect their patients and practices by ensuring they are sourcing their drugs from reputable suppliers.Federal Laws Regulating Legal CompoundingTraditional drug compounding is a practice in which a licensed pharmacist (or a physician), pursuant to a valid prescription, combines, mixes or alters the ingredients of a drug to create a new medication that is tailored to the specific needs of an individual patient (whose needs cannot otherwise be met by an FDA-approved drug). For example, if a patient is allergic to a specific inactive ingredient in an FDA-approved medication, a licensed pharmacist can, pursuant to a physician’s prescription, create a new version of the medication without the offending ingredient. Similarly, if a pediatric patient cannot tolerate the taste of the FDA-approved medication, a licensed pharmacist can, pursuant to a physician’s prescription, create a new version of the medication by adding a flavoring. This is a medically necessary practice and is perfectly lawful.Over the course of the last several decades, however, compounding has grown beyond its historic focus on individual patients. Indeed, rogue players have begun manufacturing and distributing drug products in bulk – under the guise of engaging in traditional pharmacy compounding – in violation of federal drug manufacturing laws. In fact, this unlawful practice led to a multistate outbreak of fungal meningitis in 2012 that killed 64 patients and affected nearly 800 others. The outbreak was caused by the New England Compounding Center (“NECC”), which shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to healthcare facilities in 23 states.In response to that public health tragedy, Congress in November 2013 enacted the Compounding Quality Act (“CQA”) as part of the Drug Quality and Security Act (“DQSA”) of 2013 (Pub. L. 113-54). The CQA amended the Federal Food, Drug and Cosmetic Act (“FD&C Act”) by re-enacting one regulatory pathway (and then creating a second pathway) for entities that wish to lawfully compound drug products.The first pathway is set forth in Section 503A of the FD&C Act. Under 503A, Congress once again recognized the importance of traditional pharmacy compounding. Entities engaged in traditional pharmacy compounding are exempt from three specific federal rules applicable to drug manufacturers (i.e., compliance with current good manufacturing practices (“cGMPs”), labeling with adequate directions for use, and FDA approval prior to marketing) provided that they (1) limit their compounding to prescriptions for identified individual patients and make no more than limited quantities of compounded drugs in advance of receiving prescriptions, (2) do not make drugs (either regularly or in inordinate amounts) that are essentially copies of commercially available drugs, and (3) use permissible bulk ingredients. Products prepared by traditional pharmacy compounders also must not be contaminated or prepared under insanitary conditions; the drugs must be the correct strength and purity; and the drug product’s labeling, advertising, and promotion must not be false or misleading.The second pathway is set forth in Section 503B of the FD&C Act. Under 503B, so-called “outsourcing facilities” may compound drugs in unlimited quantities (without first receiving prescriptions) if they are compounding drugs for which there is a drug shortage or compounding drugs using specific bulk ingredients, as identified on a list published by FDA, for which there is a clinical need. However, outsourcing facilities, similar to traditional pharmacy compounders, cannot compound drugs that are