Sharing an active ingredient with an approved drug does not make a compounded medicine FDA-approved.
Claim source: FDA compounded-drug guidance, summarized in CA-compounding-02.
Further reading
Read the record behind the claim
An official record can answer one question and leave others open. A medicine’s approval record, for example, says nothing about whether a Denver clinic is offering that same product. Start with your question, then choose the record built to answer it.
Product question
Use FDA records for approval and compounding
Search by the generic name. The FDA’s online list of medicines shows whether a product was approved. The FDA’s pages on compounding explain why a made-to-order version is different.
Person and pharmacy question
Use Colorado records to check a Colorado licence
A national directory can point the way, but the state record is the place to confirm current status.
Colorado’s state licence lookup includes medical, nursing and pharmacy licences in one search tool.
Claim source: Colorado DORA licence lookup, summarized in GEO-CO-04.
Enforcement question
Read an FDA letter as a dated allegation
An FDA letter shows what the FDA told a particular company at a particular time. It is useful evidence of the agency’s reasoning, but it is not a court judgment and it may not show what happened later.
Four questions for any record
Scope, date and verb
Scope
Does the source cover this exact product, form and use?
Date
Could a price, shortage, licence or rule have changed?
Verb
“Proposed,” “registered” and “approved” are three different words with three different meanings.
Missing piece
What question does the source leave open?
A source link is there to be opened. Find the sentence that supports the claim, and check that the claim does not say more than that sentence does.