Compounding Laws and Policies (2024)

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. In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states.

Drug Quality and Security Act (DQSA)

Congress passed the Drug Quality and Security Act (DQSA) in response to the 2012 fungal meningitis outbreak, as well as numerous other serious adverse events, including deaths, linked to poor quality compounded drugs. The DQSA, which was enacted on November 27, 2013, made important updates to the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding human drug compounding. Since DQSA enactment, FDA has worked diligently to issue draft and final policy documents to implement the law.

The DQSA eliminated provisions concerning advertising of compounded drugs that had been found to be unconstitutional from existing law addressing compounding – section 503A of the FD&C Act. This removed uncertainty about the validity of section 503A, which Congress otherwise left intact.

Section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.

The DQSA also added a new section 503B to the FD&C Act, which established a new, voluntary category of compounders known as outsourcing facilities. Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements, and they may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock).

Outsourcing facilities are inspected by FDA according to a risk-based schedule, and must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

See provisions of federal law that apply to human drug compounding and FDA’s policies on other related activities for more information. See also information about the Pharmacy Compounding Advisory Committee, which provides FDA with advice as it implements certain provisions of sections 503A and 503B of the FD&C Act.

Additionally, find information on FDA’s work to develop the lists of bulk drug substances that can be used in compounding under sections 503A and 503B of the FD&C Act.

Compounding Laws and Policies (2024)


Compounding Laws and Policies? ›

The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A.

Does the FDA have legal authority over compounding pharmacies? ›

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.

What is the compounding act? ›

This legislation establishes a clear boundary between traditional compounders and compounding manufacturers, which make sterile products without or in advance of a prescription and sell those products across state lines.

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.)

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.

How are compounding pharmacies regulated? ›

FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications.

Which agencies enforce drug compounding regulations in the United States? ›

FDA. Pharmacy compounding of human drug products under Section 503a of the Federal Food, Drug, and Cosmetic Act guidance.

What is the law of compounding? ›

When you let money accumulate at compound interest over a long enough period of time, it increases more than you can imagine. You can use the Rule of 72 to determine how long it would take for your money to double at any rate of interest. Simply divide the interest rate into the number 72.

What is the penalty for compounding? ›

PENALTY FOR NON-COMPLIANCE WITH ORDER OF COMPOUNDING AUTHORITY: Any officer or other employee of the company who fails to comply with any order made by the compounding authority the maximum amount of fine for the offence proposed to be compounded under this section shall be twice the amount provided in the ...

What is compounding a crime? ›

Compounding a crime is accepting something of value from a person who has committed a crime in exchange for not reporting or not prosecuting the crime. For example, if Joe beats up Eddie, but then Eddie takes money from Joe in exchange for not reporting the assault to the police, Joe has compounded the crime.

What are the dangers of compounding? ›

In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.

Why are compounding pharmacies bad? ›

"Compounded drugs pose a higher risk to patients than FDA-approved drugs because they do not undergo FDA premarket review for safety, effectiveness, or quality," the FDA detailed, adding that compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.

Can you trust a compound pharmacy? ›

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 are the most common compounded medications? ›

The Top Ten Compounded Medications
  1. Anastrozole. Anastrozole is commonly used to treat early breast cancer in women who have already experienced menopause. ...
  2. Chrysin. ...
  3. Hydrocortisone. ...
  4. Liothyronine Sodium. ...
  5. Naltrexone. ...
  6. Tramadol. ...
  7. Prednisone. ...
  8. Sucralfate.
Nov 13, 2023

Do compounded drugs require FDA approval? ›

Compounded drugs are not FDA-approved. In some cases, they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. For example, a patient may be unable to swallow a pill or may have an allergy to an inactive ingredient in an FDA-approved drug.

Why are compounded drugs so 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. Equipment: Not all pharmacies are equipped to make compounded medications.

Who regulates 503B pharmacies? ›

The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only. Unlike a 503A facility, 503B compounding pharmacies must validate every process according to CGMP.

What legal authority does the FDA have? ›

If a biological product is in violation of the statute and/or FDA's regulations, FDA has the power to suspend or revoke the license. FDA can take this action administratively, without even having to take the license-holder to court. FDA also has the power to recall products that are no longer safe, pure, or potent.

Why aren't compounds FDA-approved? ›

Fact #3: The FDA doesn't approve compounded drugs.

Compounding is often regarded as a process in which a pharmacist or a physician combines, mixes, or alters ingredients to create medications that meet the needs of individual patients. FDA has observed that some compounders have made false and misleading statements.

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