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        Guidance, Compliance, & Regulatory Information

Human Drug Compounding

                        
                Compounding Laws and Policies
          Regulatory Policy Information
          Compounding Risk Alerts
          Compounding Oversight and Compliance Actions
          Compounding: Inspections, Recalls, and other Actions
          Information for Outsourcing Facilities
          Registered Outsourcing Facilities
          Bulk Drug Substances Used in Compounding
          Consumer and Health Care Professional Information
          Compounding Information for States
          Compounding Research


                Compounding Quality Center of Excellence Home
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          Guidance, Compliance, & Regulatory Information
          Human Drug CompoundingGuidance, Compliance, & Regulatory Information Human Drug Compounding
  	
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    PrintPharmacy Compouding Report

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

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.

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

Compounding Quality Center of Excellence

Learn more about FDA’s efforts to improve the quality of compounded drugs, primarily those made at outsourcing facilities, through the Compounding Quality Center of Excellence.

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. Also, find clarifications on FDA's policies.

Compounding Oversight and Compliance Actions

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.

Watch a webinar to learn why cleanrooms and cleanroom behaviors are important for preventing insanitary conditions that can adversely impact the quality and safety of drug products.​

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.
Watch a webinar to learn why cleanrooms and cleanroom behaviors are important for preventing insanitary conditions that can adversely impact the quality and safety of drug products.​

Bulk Drug Substances Used in Compounding

Find information on using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. FDA is working to develop the 503A bulks listand 503B bulks list, which will be updated on an ongoing basis as the agency evaluates bulk drug substances nominated for these lists. Find information to know your bulks supplier because compounding from bulk drug substances presents risks to patients.

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 to oversee compounding, as well as resources for state regulators, including information on the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs.

Compounding Research

Find information about external partnerships for compounding research.

                                                                                  Content current as of:
      01/26/2024
                  
                   
Regulated Product(s)
		 DrugsHuman Drug Compounding                
                          

                        Compounding Laws and Policies
          Regulatory Policy Information
          Compounding Risk Alerts
          Compounding Oversight and Compliance Actions
          Compounding: Inspections, Recalls, and other Actions
          Information for Outsourcing Facilities
          Registered Outsourcing Facilities
          Bulk Drug Substances Used in Compounding
          Consumer and Health Care Professional Information
          Compounding Information for States
          Compounding Research


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