Must Read!! Public Safety Concerns Support FDA Call for Compounding Pharmacy Regulation 23 September 2013 By Rachel A. Hardy, MA, RAC

When a contaminated injected steroid that killed more than 63 people and sickened at least 750 in 20 states was traced back to the New England Compounding Center (NECC) in Massachusetts, national attention turned to compounding pharmacies.¹ The public wanted to know what these businesses are and whether they are adequately regulated. Both the US Food and Drug Administration (FDA) and state authorities play a role in regulating compounding pharmacies. Unlike pharmacies that simply dispense FDA-approved, legally marketed drugs, compounding pharmacies make drugs. Some start with pharmaceutical ingredients, and some alter marketed drugs—for instance, by repackaging them. Yet, because the lines of authority are poorly delineated, facility oversight is inadequate. To increase public trust in the drug supply, new regulatory solutions must be considered.

Definitions: CGMP and Pharmacy Compounding

Good Manufacturing Practice (GMP) and the practice of compounding are distinctively defined in law and guidance. Current Good Manufacturing Practice (CGMP) is defined in 21 CFR 210: “Minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug ensures … that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess….The failure to comply…shall render such drug to be adulterated.”²

Pharmacy compounding is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 353a): “if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient,”³ and meets some other requirements, including “made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs,” then the drug is exempt from parts of the act regulating adulterated drugs, misbranded drugs, and Investigational New Drug applications.⁴

Drug Safety versus Scarcity

Three major factors have raised public concern about compounding pharmacies. The first was the NECC meningitis outbreak—as well as other public health incidents—that led to questions about the safety of compounded drugs. Another is the increasing reliance of patients on particular compounded drugs, such as injectable steroids andcancer treatments, a trend attributed to shortages and high costs of FDA-approved drugs. Greater use, in turn, exposes more people to potential risks of compounded medications.

In response to the nationwide meningitis outbreak, Congress raised an alarm about the safety of compounded drugs. The US House and Senate each have hosted hearings on compounding pharmacies and currently are working toward legislation. FDA Commissioner Margaret Hamburg testified before the Senate:

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