Insights.
Ten pieces on the documents and the rules behind a compounded preparation. Each one is written against the statute, the regulation or the compendial chapter it cites, and every citation is listed at the foot of the piece.
The collection
Ten entries, grouped by subject and numbered in reading order. The law first, then the documents, then the supplier.
Compounding law
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01
The 503A bulk drug substances list: Category 1, 2 and 3.
The three categories on FDA's 503A bulk drug substances list are stages of one evaluation, not grades of quality, and only one of them carries a stated enforcement position.
7 min Compounding law -
02
503A, 503B and office-use purchasing: who may buy what
Section 503A and section 503B are two different exemptions with two different tests.
10 min Compounding law -
03
USP 797 beyond-use dates: Category 1, 2 and 3.
The revised chapter ties a beyond-use date to the environment a preparation is made in and the testing it passes, not to how complex it is.
10 min Compounding law
Documents
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04
What a complete certificate of analysis contains
Federal law requires a bulk drug substance to arrive with a valid certificate of analysis and never defines valid.
9 min Documents -
05
Reading a peptide CoA: purity, content, counterion
A peptide certificate of analysis carries three figures that look like they measure the same thing.
9 min Documents -
06
Lot traceability, from a supplier CoA to a recall-ready file.
A recall is a records exercise run under time pressure.
10 min Documents
Sourcing
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07
API supplier qualification: the checklist an inspector reads
An API supplier qualification file is built from three statutory conditions, one identity test that cannot be delegated, and a set of public records that answer in a lookup rather than in a phone call.
10 min Sourcing -
08
Verifying an API manufacturer is registered with FDA.
Most of the value in a supplier check is knowing what each database does not prove.
6 min Sourcing -
09
The analytical package: endotoxin, sterility, solvents, metals.
A certificate of analysis and a release record answer different questions.
8 min Sourcing
Handling
What this writing is
This writing describes the law and the compendial standards as they are published. It is not legal advice and it is not a substitute for reading the provision a decision rests on. Where a chapter sits behind a subscription, the piece says so rather than paraphrasing text it could not read.
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