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CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer

FinalCenter for Drug Evaluation and Research10/01/1980
current good manufacturing practice

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2
new drug

exportation of a new drug that is not covered by an approved NDA

investigational drugs

Guidelines present acceptable current approaches to the study of investigational drugs in man.; Drugs undergoing clinical trials in man.

Stakeholders

3
physician-investigator

Individual who may delegate record maintenance to a pharmacist

sponsor

responsible for justifying omission of studies

hospital pharmacy

Entity compounding medication and subject to registration rules

Regulatory Context

Regulatory Activities

2
antibiotic certification

Requirement for antibiotic preparations compounded by pharmacies

registration

Outsourcing facilities registered under section 503B

Technical Details

Substances

1
new drug substance

The active ingredient being modified in synthesis or fermentation.

View on FDA.gov

Related CFR Sections (2)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Quality control unit failed to exercise its responsibility
101
Failure to conduct at least one test to verify the identity of each component
95
Failure to establish adequate written procedures for production and process control
88
Failure to thoroughly investigate any unexplained discrepancy or failure of a batch
56
Failure to have appropriate laboratory determination of satisfactory conformance to final specifications
56
Failure to establish an adequate quality control unit
49
Failure to test samples of each component for identity and conformity
47
Failure to establish laboratory controls
35
Failure to thoroughly investigate any unexplained discrepancy
28
Failure to test samples of each component for identity
25

Recent Cases

Related Warning Letters (10)

See Also (8)