Questions and Answers
What act did President Theodore Roosevelt sign into law on June 30, 1906?
The United States Pharmacopeial Convention, Inc. purchased the National Formulary in 1975 to unify official compendia.
True
What is the designation of the combined compendium published in 1980?
USP XX/NF XV
The USP/NF is released every ______ and made official in the following May.
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Match the year with the corresponding event related to drug standards:
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What is the main purpose of the Prescription Drug Marketing Act of 1987?
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Tranexamic acid is categorized under Category C for drug risks during pregnancy.
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What drug is classified under Category D for pregnancy risks?
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The ___ is the act that regulates labeling claims made for dietary supplements.
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Match the drug category with its description:
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Study Notes
Drug Standards and Regulations
- Pure Food and Drug Act (June 30, 1906): Signed by President Theodore Roosevelt, marking the establishment of legal standards for medical and pharmaceutical substances.
- United States Pharmacopeia (USP): The official compendium sets standards for drugs, including purity, quality, and strength, recognized by government agencies.
- National Formulary (NF): Merged with USP in 1975, creating a unified national compendium for pharmaceuticals.
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Dosing Categories:
- Category C: Adverse effects in animal studies; potential benefits may justify use in pregnant women despite risks.
- Category D: Positive evidence of human fetal risk; benefits may still warrant use.
Drug Dosage and Administration
- Usual Dosage: Amount expected to produce the intended medicinal effect in adults.
- Usual Dosage Range: Prescribed amounts within typical medical practice.
- Pediatric Dose: Dosage specifically for children.
- Initial Dose: Amount required to reach desired concentration in the bloodstream.
- Therapeutic Dose: Dose given to achieve the desired therapeutic effect.
- Prophylactic Dose: Administered to prevent illness before exposure.
Drug Stability and Expiration
- Expiration Date: Limits the time a drug can be dispensed or used.
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Types of Stability:
- Chemical Stability: Retains chemical integrity and labeled potency.
- Microbiologic Stability: Resistance to microbial growth.
- Physical Stability: Preservation of the drug's appearance and other physical characteristics.
- Toxicologic Stability: Consideration of adverse effects due to instability.
Methods of Enhancing Drug Stability
- Water Elimination: Reducing water content to prevent hydrolysis; can involve waterproof coatings or tightly closed containers.
- Liquid Substitutes: Using alternatives (e.g., glycerin, propylene glycol) to replace or reduce water in formulations.
- Solvent Use: Anhydrous vegetable oils in injectables to reduce hydrolytic decomposition.
Rate Reactions in Drug Stability
- Zero-order Kinetics: Drug loss is constant over time; independent of concentration.
- First-order Kinetics: Drug loss is proportional to remaining concentration; dependent on time.
- Oxidation: Prevented using antioxidants, which stop the oxidative chain reactions that could lead to stability loss.
Important Legislation
- Drug Price Competition and Patent Restoration Act: Allows applications for generic drug copies through abbreviated new-drug applications (ANDA).
- Prescription Drug Marketing Act (1987): Aims to protect against misbranded or adulterated drugs in the marketplace.
- Dietary Supplement Health and Education Act: Regulates labeling claims for dietary supplements.
Therapeutic Considerations
- Concomitant Drug Therapy: The influence of drug interactions may modify therapeutic effects; awareness of polypharmacy is critical.
- Tolerance: Ability to endure the effects of a drug with continuous use, potentially requiring increased dosage for the same effect.
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Description
Explore the historical methods for isolating compounds such as quinine, cinchonine, strychnine, and brucine. This quiz covers key events including President Theodore Roosevelt's signing of the Pure Food and Drug Act in 1906, which had significant impacts on drug regulation.
