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Tuesday, July 25, 2017

FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)













Just over three years ago, on November 27, 2013, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. In particular, in 2012, injectable drug products produced by a compounder and shipped across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection, affecting patients in 20 states.

Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate quality standards (e.g., if an injectable drug is contaminated, or if a tablet contains too much active ingredient), it could cause serious injury or death. Therefore, in implementing and enforcing the compounding-related provisions of the FD&C Act, FDA seeks to strike a balance between preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not produced in accordance with the applicable requirements of federal law.

FDA has devoted significant agency resources to implementing and enforcing the compounding-related provisions of the FD&C Act, including those added by the DQSA, in the wake of the 2012 fungal meningitis outbreak and other serious injuries and deaths.

Over the past three years,

FDA has:

• Significantly increased its inspections of facilities where drugs are being compounded and taken appropriate regulatory actions in response to violations of the law that put patients at risk;

 • Issued numerous policy documents, including draft and final guidance documents and proposed and final regulations;

• Convened advisory committee meetings to obtain advice on scientific, technical, and medical issues concerning drug compounding;

• Obtained input from stakeholders through a variety of different mechanisms; and


• Worked closely with states to share information and coordinate efforts.


The Regulatory Framework and History of Drug Compounding Regulation

Most prescription drugs are required to:

• undergo premarket approval to demonstrate safety and efficacy;

• be labeled with adequate directions for use so patients can safely use drugs for their intended purposes; and

 • be manufactured according to current good manufacturing practice (CGMP) requirements, which are intended to assure the identity, strength, quality, and purity of drugs by requiring adequate control of manufacturing operations.

These requirements provide important protections to patients. Under certain conditions, however, compounded drug products are not subject to these requirements. Other protections, such as the prohibition on preparing drugs under insanitary conditions, apply to all drug products, including compounded drugs.


What is Drug Compounding?

Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a sterile or non-sterile medication tailored to the needs of a patient. Compounded drugs are not FDA-approved.

A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy and needs a medication to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form that is not otherwise available. Practitioners in hospitals, clinics, and other health care facilities sometimes administer or dispense compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.

In these situations, compounding can serve an important patient need. However, some compounders engage in inappropriate compounding activities. For example, FDA is aware that some compounders produce drugs for patients even though an FDA-approved drug may have been medically appropriate for them. FDA has also observed that some compounders have advertised compounded drugs as safe and effective, sometimes for the treatment of serious diseases, incorrectly suggesting the drugs had met the standard for FDA approval.

Risks of Compounded Drugs

Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. FDA also has observed that the labeling of compounded drugs often omits important information such as directions to help ensure that the drugs are used safely and warnings about possible side effects and drug interactions. In addition, and of particular concern, poor compounding practices can result in serious drug quality problems, such as contamination or medications that do not possess the strength, quality, and purity they are supposed to have. This can lead to serious patient injury and death.

In October 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history. A pharmacy in Massachusetts shipped contaminated compounded drugs to patients and health care providers throughout the country. The drugs, which were contaminated with fungal growth, were injected into patients’ spines and joints. More than 750 people in 20 states developed fungal infections, and more than 60 people died as a result. Approximately 14,000 patients received injections from the lots of contaminated drug product.


Source: FDA

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