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 drugto 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 awebinarto learn why cleanrooms and cleanroom behaviors are important for preventing insanitary conditions that can adversely impact the quality and safetyof drug products.
Information for Outsourcing Facilities
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 list and 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.
FAQs
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.
What is an example of drug compounding? ›
An HCP may create a compounded medication if you need a certain combination of drugs that isn't available commercially. An example of this is a compounded topical cream for treatment-resistant neuropathic pain that includes: amitriptyline. baclofen.
How do you compound a drug? ›
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.
Does the FDA approve compounded drugs? ›
Compounded drugs are not FDA-approved. This means that FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they reach patients. FDA has investigated many cases of serious patient injury linked to poor quality compounded drugs.
Does insurance cover compounded medications? ›
Will insurance cover a compounded medication? Sometimes, but not always. And some compounding pharmacies don't take insurance at all. It's best to discuss cost up-front before you have your prescription filled.
Is compounded semaglutide the same as Ozempic? ›
Information for consumers. You should be aware that compounded semaglutide-like products are not identical to the approved product Ozempic. Compounded semaglutide-like products have not been evaluated for safety, quality and efficacy by us.
Are nurses allowed to compound medications? ›
No registered nurse shall compound drugs.
What is the difference between medication and compounding? ›
The medications used in compounding formulas, when broken down, are virtually identical from a chemical perspective. The only real difference is that compounding pharmacies combine the ingredients in-house to meet the individual patient's needs.
What are two examples of compounding? ›
Closed compounds are compounds that consist of two words combined together without a space in between. Some examples of closed compounds include blackboard, sweatshirt, backstroke, undercut, horseshoe, desktop, and smartphone.
Is Adderall a compound medication? ›
Adderall is a combination of four amphetamine salts (D-amphetamine saccharate, D- amphetamine sulfate, D,L-amphetamine sulfate, and D,L-amphetamine aspartate), with a 3 : 1 ratio of D-isomer to L-isomer.
It typically takes 24 to 48 hours for us to prepare a compounded medicine. In the case of especially complex formulations, additional time may be needed. However, emergencies do happen.
Are compounded medications more expensive? ›
Ingredients: The personalization involved in compounding medications means that specialized ingredients may be involved. When specialty ingredients need to be sourced, and often in smaller quantities, this can drive up the cost of materials.
Is compounding illegal? ›
Properly compounded versions are legal for anyone with a prescription, says Scott Brunner, CEO of Alliance for Pharmacy Compounding (APC), an advocacy organization. (Some states have tried to ban the compounding of semaglutide, but they may be on shaky legal ground due to conflicts with federal law.)
What medications should be compounded? ›
Compounding medications include:
- acetylcysteine 5% oral suspension: 50mg/ml.
- acetazolamide oral suspension: 25mg/ml.
- allopurinol oral suspension: 20mg/ml.
- all-purpose nipple ointment.
- ammonium chloride oral suspension: 50mg/ml.
- amiodarone oral suspension: 5mg/ml.
- amlodipine oral suspension: 1mg/ml.
In general, most compounding pharmacies are safe. Again, a licensed pharmacist or physician must supervise combining and ingredient altering practices. This helps to ensure your safety and the quality of the medications you take.
What does it mean if a pharmacy does compounding? ›
Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs.
Why do patients need to go to a compounding pharmacy? ›
If the medicine you need isn't available in a premade form from a manufacturer, your health care professional might prescribe a compounded drug. Pharmacists can mix a drug to: Customize the dosage. Add flavor (for a child or pet)
What is the benefit of compounding drugs? ›
Compounding pharmacies help people get their prescription drugs down without a hassle. Because they put the medications together for you, they can formulate things like liquid suspension and chewable tablets that are easier to take.
