Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series! Today’s topic: the Complexities of Compounding
Just over three years ago, Congress amended the Federal Food, Drug, and Cosmetic Act by enacting the Drug Quality and Security Act (or DQSA). Since enactment of the DQSA, the FDA has worked diligently to mitigate the public health risks associated with compounded drugs by conducting inspections and taking appropriate regulatory and enforcement actions, developing policies, convening advisory committee meetings, collaborating and coordinating with states, and conducting stakeholder outreach. These efforts are detailed in the FDA’s recently released Human Drug Compounding Progress Report.
Compounding is often regarded as the process of combining, mixing, or altering ingredients to create a sterile or non-sterile medication customized to suit the needs of a patient.
Compounded drugs can serve an important role when an FDA-approved drug is not medically appropriate to treat a patient, such as when a patient needs a medication to be made without a certain dye because of an allergy.
However, compounded drugs are not FDA-approved, which means they have not been reviewed by FDA for safety, effectiveness, or quality before they are marketed. 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 can cause serious injury or even death.
FDA has investigated numerous serious adverse event reports associated with contaminated, super-potent, mislabeled, or otherwise poor quality compounded drugs. A fungal meningitis outbreak in 2012 was linked to contaminated compounded drugs that a pharmacy shipped to patients and healthcare providers in 20 states. More than 750 people were seriously harmed and more than 60 people died.
Between 2013 and 2016, the FDA significantly increased its regulatory oversight of compounders by:
- Conducting more than 350 inspections
- Issuing more than 130 warning letters advising compounders of significant violations of federal law
- Issuing more than 30 letters referring inspectional findings to state regulatory agencies,
- Overseeing about 100 recalls involving compounded drugs
- And by working with the Department of Justice on a number of civil and criminal enforcement actions
Also between 2013 and 2016, the FDA developed numerous policies, convened multiple advisory committee meetings, collaborated and coordinated with state regulators, and conducted stakeholder outreach. Specifically, the FDA:
- Issued 18 draft guidances, seven final guidances, two proposed rules, a final rule, and a draft memorandum of understanding;
- The FDA also convened six advisory committee meetings to obtain advice on scientific, technical, and medical issues concerning drug compounding;
- It held four intergovernmental working meetings with state regulators, invited states to accompany FDA investigators on inspections, and had numerous one-on-one interactions;
- The FDA held four sets of listening sessions with more than 75 stakeholders, including, pharmacy, hospital, long-term care, and other medical organizations; and
- Obtained input from stakeholders through a variety of different mechanisms.
Examples of recently issued policy documents include:
- This guidance describes the conditions under which FDA does not intend to take action for certain violations when a state-licensed pharmacy, federal facility, or outsourcing facility repackages certain drug products.
- This guidance addresses the prescription requirement in section 503A of the Federal Food, Drug, and Cosmetic Act, including FDA’s policies regarding compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of such a prescription, and compounding for office use.
- This proposed rule proposes that six bulk drug substances be included, and four bulk drug substances not be included, on a list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act.
The FDA will continue to oversee drug compounders and will take regulatory action when appropriate to continue to protect public health. The agency is committed to building on its progress to protect patients and will continue to inspect and enforce the law against compounders. It will also develop policy, hold advisory committee meetings, collaborate and coordinate with states, and communicate with stakeholders.
A link to this full SBIA Chronicle article and more information about CDER’s SBIA Program may be found at: www.fda.gov/cdersbia. Thanks for tuning in.