The myth to check
Does a business record prove a medicine is approved?
Read the fact
The fact
FDA registration records a business that makes or handles drug products. A drug listing records the product that business reports to the FDA.
As of September 26, 2026, federal rules say these records prove neither that a medicine has FDA approval nor that it may be sold legally.
A National Drug Code (NDC) is a number that identifies a drug product in the FDA’s directory. A seller may show it beside the product.
The FDA says an NDC number is not proof that it approved the medicine. Ask for the actual approval record.
Ask what was actually checked
As of September 26, 2026, FDA approval covers a particular medicine for particular uses. A medicine mixed or made to order, called a compounded medicine, has no FDA approval.
A licence answers a different question: which person or pharmacy has permission to practise or operate.
Neither a badge nor a product code replaces looking at the actual record.
Research labels do not settle the rules
As of September 26, 2026, FDA warning letters say a “research use only” label does not avoid medicine rules. That applies when a seller markets the product for people to take.
In a September 26, 2026 warning, the FDA describes unapproved weight and diabetes products with research labels being sold for people to take. Their quality is not known, and harm may result from their use.
Ask whether the exact product is FDA-approved or made by a licensed pharmacy to meet a patient’s need.
Taking back a request does not give permission
For medicines made to order for named patients, one ingredient rule uses an FDA list. An ingredient request asks the FDA to add a raw ingredient to that list.
As of September 26, 2026, the FDA lists BPC-157, one peptide ingredient, among requests taken back by the people who filed them.
The FDA’s warnings remain beside those ingredients. For BPC-157, it says there is too little human safety information to know whether using it would cause harm.
For some injected peptides, FDA concerns include the body reacting against the peptide and uncertainty about what is in the medicine.
As of September 26, 2026, taking back an ingredient request does not give FDA approval. It also does not put the ingredient under the FDA’s temporary policy of not taking action.
That policy covers a separate group called Category 1, only when its conditions are met. It states when the FDA does not plan to act; it does not make an ingredient lawful to use.
Ask: Which rule allows this pharmacy to use this exact ingredient? A request that was taken back is not that proof.
The FDA’s Pharmacy Compounding Advisory Committee gives the agency advice about ingredients. Its advice does not change the list: the FDA must finish its reviews and change the rule.
Arizona permission and product rules are separate
As of October 6, 2026, Arizona’s custom-medicine rule sets standards for pharmacies filling named patients’ prescriptions. Larger facilities making batches under a different federal system follow separate standards.
The pharmacies filling individual prescriptions are called 503A pharmacies. The batch-making businesses are called 503B facilities; they follow federal factory quality rules.
A state permit does not settle whether every ingredient or product meets the other rules.
Ask the pharmacy which kind of facility it is and which record shows it meets those standards.
Ask the person writing your prescription: Which state and federal rules allow this exact medicine and ingredient to be supplied to me?
Read a health claim with these questions
- Does the evidence concern this exact product and this use?
- Who published it: a government agency, a board or the business making the claim?
- Is it a rule, guidance, a proposed change or advice from a committee?
- What date does the claim use, and what might have changed since then?
Ask for the original source and a plain explanation of what it can show. A confident tone is not evidence.
Look it up
Sources for this chapter
- FDA: what approval means
The difference between a medicine approval and a business record.
- FDA: drug-directory codes
What a product code can and cannot establish.
- FDA: ingredient concerns and requests taken back
Open the FDA’s original ingredient tables.
- FDA: ingredient rules for medicines made to order
The allowed-ingredient list and temporary policy conditions.
- Arizona: the amended compounding rule
The replacement rule, rather than its older wording.
Keep reading
Use the Arizona care checks