Drugs

Human Drug Compounding

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Pharmacy Compounding Report 
FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)
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Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

Questions? Email FDA’s compounding team at compounding@fda.hhs.gov.

Recent Announcements and Actions

Compounding Laws and Policies

Find information about federal law and FDA policies that apply to compounding and other activities compounders undertake. Read section 503A and section 503B of the Federal Food, Drug, and Cosmetic Act. Learn more about federal law provisions that apply to human drug compounding and FDA policies on compounding and other related activities. Find a list of compounding policy documents and information about the Pharmacy Compounding Advisory Committee.

Compounding Risk Alerts

Find information on risks associated with certain compounded drugs.

Compounding Oversight

Find links to compounding inspections, recalls, and other actions, as well as descriptions of some of the documents and actions involved in FDA oversight of compounding. Learn about the risks associated with certain compounded drugs. Also, find answers to frequently asked questions about FDA inspections of compounders.

Information for Outsourcing Facilities

Find general information for outsourcing facilities, as well as a list of currently registered outsourcing facilities. Thinking of registering as an outsourcing facility? Find answers to frequently asked questions for entities considering registration, information on facility fees and how to register and submit product reporting information to FDA.

Information for Consumers and Health Care Professionals

Find resources for consumers who use compounded medicines and health care professionals who prescribe compounded medicine, including answers to frequently asked questions and how to report adverse events and product complaints to FDA.

Information for States

Find information regarding FDA and state collaboration [hyperlink] to oversee compounding, as well as resources for state regulators.

 

Page Last Updated: 09/12/2018
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