# Compounded vs FDA-approved drugs > What FDA approval means, what drug compounding is, how the two differ, and the risks FDA has named for compounded drugs. - Canonical URL: https://livingpluspeptides.com/regulation/compounded-vs-fda-approved-drugs/ - Last updated: October 25, 2026 - Publisher: Living+ An FDA-approved drug has had its data reviewed by FDA, which found that its benefits outweigh its known and potential risks for the people it is meant for [1]. A compounded drug is made by a pharmacist or doctor for one patient's needs, and it is not FDA approved. FDA does not check a compounded drug's safety, effectiveness or quality before it is sold [3, 4]. ## What FDA review means FDA's Center for Drug Evaluation and Research (CDER) evaluates new drugs before they can be sold [1]. A drug maker must first test the drug in the lab, in animals and then in people. It then sends the evidence to CDER [1]. A team of doctors, statisticians, chemists, pharmacologists and other scientists reviews the data and the proposed label [1]. FDA usually expects results from two well-designed clinical trials. This helps show the findings are not the result of chance or bias. For some rare diseases, one convincing trial may be enough [1]. The formal request for approval is a new drug application (NDA). After an NDA arrives, FDA has 60 days to decide whether to file it for review [2]. Reviewers check whether the studies show the drug is safe and effective for its proposed use [2]. FDA also reviews the professional label and inspects the facilities where the drug will be made [2]. Approval is not the end. FDA keeps tracking approved drugs for adverse events through a postmarketing surveillance program [2]. One way FDA manages a drug's risks is the FDA-approved label, which describes the drug's benefits and risks and how the risks can be found and managed [1]. ## What compounding is FDA describes compounding as a practice in which a licensed pharmacist or doctor combines, mixes or alters drug ingredients to make a medicine for one patient's needs. In an outsourcing facility, a person supervised by a licensed pharmacist may do this [3]. FDA gives examples of why a patient may need a compounded drug. One patient may be allergic to a dye and need a version without it. An older adult or a child may not be able to swallow a tablet and need a liquid [4]. Compounders may also make versions of a drug on FDA's drug shortage list if federal conditions are met [4]. A compounded drug is not the same as a generic. A generic drug is approved by FDA and must show it is therapeutically equivalent to the brand, among other rules. A compounded drug is not approved [4]. ## The two federal paths for compounding Section 503A of the Federal Food, Drug, and Cosmetic Act covers compounding by a licensed pharmacist in a state-licensed pharmacy, or by a doctor, for an identified patient with a valid prescription [6, 7]. These drugs are exempt from FDA approval, current good manufacturing practice (CGMP) rules and labeling with adequate directions for use [6]. State boards of pharmacy do most of the day-to-day oversight of these pharmacies [4]. Section 503B covers outsourcing facilities, a group created in 2013 by the Drug Quality and Security Act [4]. They must follow CGMP rules, are inspected by FDA on a risk-based schedule, and may fill orders for office stock [4, 6]. Our page on [503A vs 503B pharmacies](/regulation/503a-vs-503b-pharmacies/) explains the split in more detail [6]. Under 503A, a bulk ingredient must meet a USP or National Formulary monograph if one exists. If none exists, it must be a component of an FDA-approved drug or appear on FDA's 503A list [7]. The [FDA Peptide Status Tracker](/regulation/tracker/) shows where each peptide on this site stands [7]. Biologics cannot be compounded under 503A or 503B. Federal law gives no legal path to market a biologic made outside an approved biologics license application [4]. ## The risks FDA names FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug [4]. Poor compounding can cause contamination or a drug with too much or too little active ingredient. This can lead to serious injury and death [4, 5]. FDA also notes that compounded drug labels may lack important information, such as adequate directions for use [5]. FDA keeps finding insanitary conditions at compounding facilities during inspections [5]. In 2012, contaminated drugs from one Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths in 20 states [6]. ## The GLP-1 example FDA has a page on its concerns with compounded GLP-1 drugs such as [semaglutide](/peptides/semaglutide/) and [tirzepatide](/peptides/tirzepatide/) [8]. As of May 31, 2026, FDA had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide [8]. State-licensed pharmacies that are not outsourcing facilities do not have to report adverse events to FDA, so FDA says these events are likely underreported [8]. FDA lists other concerns: dosing errors, doses above the approved label, salt forms of semaglutide, drugs that arrive warm, and fraudulent labels naming pharmacies that did not make the product [8]. FDA also says [retatrutide](/peptides/retatrutide/) and [cagrilintide](/peptides/cagrilintide/) cannot be used in compounding under federal law [8]. FDA asks patients, health care professionals and compounders to report adverse events or quality problems to its MedWatch program [8]. ## Frequently asked questions ### Are compounded drugs FDA approved? No. FDA says compounded drugs are not FDA approved, so it does not verify their safety, effectiveness or quality before they are sold [4]. ### Is a compounded drug the same as a generic? No. A generic is approved by FDA and must show therapeutic equivalence to the brand. A compounded drug is not approved [4]. ### Why would a doctor prescribe a compounded drug? FDA's examples include a patient allergic to a dye in the approved product, or a child or older adult who needs a liquid instead of a tablet [4]. ### Who inspects compounding pharmacies? State boards of pharmacy oversee most state-licensed pharmacies day to day. FDA mainly oversees 503B outsourcing facilities and inspects them on a risk-based schedule [4]. ### How many trials does FDA usually want before approval? FDA generally expects two well-designed clinical trials. For some rare diseases, one convincing trial may be enough [1]. ### Can peptides be compounded? Only if the ingredient meets federal rules, such as having a USP monograph, being part of an approved drug, or being on FDA's 503A list. Biologics cannot be compounded [4, 7]. ### How do I report a problem with a compounded drug? FDA asks people to report adverse events or quality problems to its MedWatch Adverse Event Reporting program [8]. ## Sources 1. [FDA: Development and Approval Process (Drugs)](https://www.fda.gov/drugs/development-approval-process-drugs) 2. [FDA: The FDA's Drug Review Process, Continued](https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued) 3. [FDA: Human Drug Compounding](https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding) 4. [FDA: Compounding and the FDA, Questions and Answers](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) 5. [FDA: Understanding the Risks of Compounded Drugs](https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs) 6. [FDA: Human Drug Compounding Laws](https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws) 7. [21 U.S.C. 353a (FD&C Act section 503A), U.S. Code 2024 edition (govinfo)](https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec353a.htm) 8. [FDA: Concerns with unapproved GLP-1 drugs used for weight loss](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) Educational information, not medical advice. This site sells nothing.