Approved, Compounded, and Unapproved: Understanding the Terms

"Approved," "compounded" and "unapproved" sound like three grades of the same thing. They are not. Each describes a different legal route by which a drug can reach a person in the United States, and each answers a different question. This guide explains the three terms using the FDA's own pages and records, as checked on October 18, 2026; the compounding sections were re-checked on November 3, 2026.

What FDA approval covers

For most new drugs, approval runs through a New Drug Application (NDA). Since 1938, every new drug has needed an approved NDA before it could be sold commercially in the United States. The application gives the FDA the evidence to decide whether the drug is safe and effective for its proposed use, whether its labeling is right, and whether its manufacturing keeps the product's identity, strength, quality and purity ^{Source [1]}. Approval means the FDA's drug center reviewed the data and concluded that the benefits outweigh the known and potential risks for the intended population ^{Source [2]}.

Approval belongs to a specific product, not to a molecule in general. Semaglutide shows this well. Wegovy injection is approved under NDA 215256, first approved on June 4, 2021 ^{Source [3]}. Wegovy tablets, taken by mouth, needed their own application, NDA 218316, first approved on December 22, 2025 ^{Source [4]}. Same ingredient, same brand name, two forms, two approvals.

Size matters too. Under an FDA rule effective March 23, 2020, a chain of more than 40 amino acids with a defined sequence counts as a protein, and the rule treats "protein" as distinct from "peptide" ^{Source [5]}. Proteins are biological products, which reach the market through a Biologics License Application (BLA) rather than an NDA ^{Source [6]}. That distinction carries into compounding: the FDA says biological products are not eligible for the compounding exemptions at all ^{Source [7]}.

What "compounded" means

Compounded drugs are not FDA-approved. The FDA does not check their safety, effectiveness or quality before they are sold, and a compounded drug is not a generic: generics are approved and must show therapeutic equivalence to the brand ^{Source [7]}. Federal law sets out two compounding routes.

Section 503A: pharmacies and physicians

A state-licensed pharmacy or physician compounding under section 503A must work from a prescription for an individual patient. It also may not compound, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available product ^{Source [8]}. State boards of pharmacy do most of the day-to-day oversight of these pharmacies ^{Source [7]}.

The raw ingredient matters as well. A 503A compounder may use a bulk drug substance only if it has an official USP or NF monograph, is a component of an FDA-approved drug, or appears on the FDA's 503A bulks list. While the FDA reviews nominations for that list, it sorts them into interim categories: category 1 (under evaluation), category 2 (significant safety risks identified) and category 3 (nominated without enough supporting information). Substances nominated on or after January 7, 2025 are no longer placed into these categories, and the FDA adds substances to the list itself through notice-and-comment rulemaking ^{Source [9]}.

Section 503B: outsourcing facilities

Outsourcing facilities are a category of compounders created in 2013. They register with the FDA, are inspected on a risk-based schedule and must meet current good manufacturing practice requirements ^{Source [7]}. They may compound from bulk ingredients only if the substance is on a separate 503B bulks list or the drug is on the FDA's drug shortage list at the time ^{Source [8]}.

The GLP-1 shortage years

Shortages explain why compounded semaglutide and tirzepatide became so common. Both injection products had been in shortage since 2022. The FDA declared the tirzepatide shortage resolved on October 2, 2024, re-evaluated that decision and confirmed it on December 19, 2024. It declared the semaglutide shortage resolved on February 21, 2025. Each announcement came with a wind-down period for compounders. For semaglutide, it ended in April 2025 for 503A pharmacies and on May 22, 2025 for outsourcing facilities ^{Source [8]}.

As of the FDA's April 2026 update, neither drug was on the 503B bulks list or the shortage list. The agency also gave an example of what it may treat as an essentially-copied product: semaglutide combined with vitamin B12, given the same way and in similar strengths as approved products ^{Source [8]}. On April 30, 2026, the FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list, finding no clinical need ^{Source [10]}. The proposal appeared in the Federal Register on May 1, 2026 ^{Source [11]}, and a later notice extended the comment period to July 30, 2026 ^{Source [12]}. We found no final notice in the Federal Register as of November 3, 2026.

Safety reporting is incomplete. As of May 31, 2026, the FDA had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide. Pharmacies that are not outsourcing facilities do not have to report, so the agency considers these likely undercounts ^{Source [13]}.

Research peptides and the compounding lists

Several peptides sold online have moved through the FDA's compounding categories. BPC-157, CJC-1295, MOTS-c and a thymosin beta-4 fragment sold as TB-500 were once in category 2. Their nominations were withdrawn, but the FDA still publishes the safety concerns it identified, such as possible immune reactions and impurities. Ipamorelin acetate remains in category 2 for 503B outsourcing facilities, listed since September 29, 2023 ^{Source [14]}. GHK-Cu for non-injectable routes is back in 503A category 1, and the FDA says it plans to consult its Pharmacy Compounding Advisory Committee (PCAC) on it before the end of February 2027 ^{Source [15]}.

The PCAC has voted on some of these. On October 29, 2024, it voted 0 in favor and 12 against (one abstention) on placing ipamorelin on the 503A list, with the same result for its free-base and acetate forms ^{Source [16]}. On December 4, 2024, it voted against several forms of CJC-1295 ^{Source [17]}. On July 23, 2026, it discussed whether BPC-157 (reviewed for ulcerative colitis), TB-500 (wound healing) and MOTS-c (obesity and osteoporosis) should be placed on the 503A list ^{Source [18]}. The FDA's own review of BPC-157 concluded that the criteria weighed against listing it ^{Source [19]}. An ABC News report from the day of the meeting said the committee nonetheless voted 8 to 6, with one abstention, in favor ^{Source [20]}. The FDA had not posted its official vote record when we checked on November 3, 2026, but an HHS policy document published in October says the committee voted in favor of all three ^{Source [21]}.

On October 30, 2026, HHS published notice of a draft interim policy on 503A compounding with certain peptides ^{Source [22]}. Its list names six: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. Until a final rule decides whether each goes on the 503A list, HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding them. That holds only for the form and routes the policy names for each peptide, and only under conditions that include a patient-specific prescription, a single active ingredient, and bulk material from an FDA-registered manufacturer with a valid certificate of analysis ^{Source [21]}. HHS may revisit the policy if a safety signal arises, and the draft is not binding ^{Source [22]}. CJC-1295, ipamorelin and GHK-Cu are not on its list.

A committee vote is not an approval, and neither is enforcement discretion. Advisory committees give non-binding advice that the FDA is not legally bound to follow ^{Source [18]}. A substance joins the 503A list only through rulemaking ^{Source [9]}; a statement that HHS does not intend to enforce the rules is not a listing. Even a drug compounded from a listed substance would still not be an FDA-approved drug ^{Source [7]}. None of this covers products sold as research use only, which the next section discusses.

What "unapproved" covers

"Unapproved" is a wide category. It includes investigational drugs being tested in registered clinical trials, which our guide to reading a clinical trial listing explains. It also includes products sold with no approved application at all. Some sellers label such products "research use only." In a 2024 warning letter, the FDA said that label did not change what the evidence on the seller's website showed: the products were intended as drugs for human use and were unapproved new drugs ^{Source [23]}. Our guide on why availability is not approval covers these signals in more detail.

How to check a status yourself

• For approval, search the product in Drugs@FDA and note the application number, dosage form and route.
• For compounding, check the date on the FDA's category lists and on any HHS or FDA enforcement policy that names the substance. They change, and a page copied months ago may be out of date.
• For committee news, look for the official vote record and any later Federal Register notice, and treat headlines about a vote as a recommendation only.
• For any of these, remember that legal status says nothing about whether a product suits you. We do not give dosing guidance or personal medical advice; our methodology explains how we check sources.