FDA Must Do More To Ensure Safety Of Compound Drugs

A growing practice of many pharmacies across the country compounding prescriptions has gone awry, endangering public health, and the Federal Drug Administration (FDA) has a responsibility to crack down on it.

Millions of Americans take prescription drugs each day to treat a wide range of ailments, but some patients’ needs can’t be met by an FDA-approved medicine. In those cases, a pharmacist combines, mixes or alters the ingredients of a drug to create a new medication that is specific to an individual patient. This process is called compounding drugs, and it does have a purpose.

For instance, pharmacists can compound FDA-approved medications as oral liquids for children and the elderly who may have difficulty swallowing tablets and capsules. Yet while compounded drugs can be beneficial to individual patients, there are also serious safety concerns about compounding pharmacies that require greater oversight than is currently being pursued by the FDA.

Unlike FDA-approved drugs, which have undergone rigorous trials and testing that can take years, the FDA does not regulate compound drugs and therefore does not test them for safety, effectiveness and quality. Most compounding pharmacies are also not routinely monitored to ensure they meet federal quality requirements.

Compounding can be a lucrative business for pharmacies as the personalized nature of compounded drugs makes them more expensive. The industry’s lack of oversight increases the potential for compounding pharmacies to sell adulterated, non-FDA approved, and substandard products to doctors’ practices as they seek to maximize profits, putting patient health and safety behind their bottom line.

The significant danger this lack of oversight poses to public health was never more evident than in 2012 when a multistate meningitis outbreak sickened over 800 people and resulted in 64 deaths after patients received contaminated steroid injections from the New England Compounding Center (NECC). The meningitis outbreak occurred after the NECC shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to health care facilities in 23 states. A subsequent FDA report found that the NECC was distributing large quantities of compounded products, “apparently for general use rather than requiring a prescription for an individual patient.”

Compounding pharmacies were originally created to allow doctors or pharmacists to make small amounts of custom, individualized medication for patients based on a doctor’s prescription. However, larger pharmacies are taking over the industry and not just altering drugs to benefit specific patients. More than half of the nation’s estimated 56,000 pharmacies perform some level of compounding with more than 7,500 large-scale pharmacies in the U.S. doing so, resulting in a $3 billion industry. They are mass producing brand new drugs and have become de-facto drug manufacturers, just with much less regulatory oversight from the FDA.

Given the potential for mistakes in compounding the drugs, as well as serious quality control concerns that can lead to contamination, stronger federal oversight is critical for public health.

In response to the New England Compounding Center tragedy, Congress enacted the Compounding Quality Act as part of the Drug Quality and Security Act of 2013. One of the main purposes of the law was to draw a distinction between small-scale compounding of drugs for individual patients and manufacturing large quantities of drugs for multiple patients.

Under the authority granted by this law, FDA recently issued three new sets of guidance to clarify the conditions under which a pharmacy can compound drugs and what kinds of pharmacies are permitted to adopt this practice. These efforts are a good first step, but FDA should consider closing some of the loopholes in their guidance.

For instance, the law permits the less-regulated compounding pharmacies to make “limited” amounts in advance of receiving a specific prescription, but the FDA’s guidance allows for compounding pharmacies to manufacture a 30-day advance supply of compound drugs — which could be dispensed to hundreds of thousands of patients depending on the pre-existing scale of the compounding pharmacy’s operations. This not only runs counter to the original intent of compound drugs, which is to tailor drugs to the specific needs of an individual patient, it also allows compounding pharmacies to cross the line into manufacturing, without being subject to FDA’s good manufacturing practice regulations for drugs.

FDA would be wise to tighten the rules to make that line clear. Those making large quantities of drugs for use by multiple patients should be deemed manufacturers and subject to FDA inspections and requirements for reporting adverse drug effects.

This is the kind of common sense oversight that would protect the necessary practice of making compound drugs, while increasing safety for millions of patients across the country.

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