Study Set Content:
, the USP-NF is revised (blank) in hardcopy and online.
annually
• Standards for Drug substances, Pharmaceutical ingredients, Dosage forms
USP and NF Monographs
includes detailed monograph of drug substances and their dosage forms
USP
includes detailed monograph of pharmaceutic ingredients
NF
Other Pharmacopeias
• Homeopathic pharmacopeia. • International pharmacopeia. • European pharmacopeia.
Canada generally uses the
USP-NF.
is the only “nongovernmental” pharmacopeia in the world.
USP-NF
The manufacturer must rigidly adhere to established initial drug and drug product standards and assay methods.
The manufacturer must rigidly adhere to established initial drug and drug product standards and assay methods.
These and future standards are adopted as new monographs by the
USP-NF
International consortium to develop and promote uniform or harmonized international standards.
International Organization for Standardization
• ISO 9000 through ISO
9004
kind of compliance of ISO
Voluntary compliance
The FDA created to enforce the
Federal Food, Drug, and Cosmetic Act of 1938.
The purpose of FDA was to enforce standards for the
Pharmaceutical industry
The Federal Food, Drug, and Cosmetic Act of 1938 purpose
“New Drug Application” • “Safety.” • “Grandfathered drugs.”
Issue: where 100 persons died
Sulfanilamide mixed with diethylene glycol
Prescription status of drugs.
Durham-Humphrey Amendment of 1951
Federal law prohibits dispensing without prescription
• Rx only or Caution
Rx only or Caution: Federal law prohibits dispensing without prescription.
Durham-Humphrey Amendment of 1951
refill authorization
Durham-Humphrey Amendment of 1951
