Research
Resource library
Primary sources first. Every entry links to the issuing body. Editorial articles are published only after expert review.
- Regulations & standards21 CFR 201.125 — Drugs for use in teaching, law enforcement, research, and analysisThe U.S. federal regulation describing when a drug may be exempt from adequate-directions-for-use labeling because it is shipped for research or analysis.ecfr.gov
- Regulations & standards21 CFR 201.128 — Meaning of “intended uses”The regulation explaining how intended use is determined from the objective intent of the persons responsible for labeling, including advertising and the circumstances of distribution.ecfr.gov
- Regulations & standards21 CFR Part 211 — Current Good Manufacturing Practice for finished pharmaceuticalsThe U.S. CGMP regulations for finished drug products, including laboratory controls and records.ecfr.gov
- Regulations & standardsFDA — Bulk drug substances used in compoundingFDA's page on the bulk drug substances that may and may not be used in compounding under sections 503A and 503B.fda.gov
- Regulations & standardsFTC — Health Products Compliance Guidance (2022)The Federal Trade Commission's guidance on substantiating health-related advertising claims.ftc.gov