Pharmacy Law Flashcards
Pure Food and Drug Act of 1906
To prohibit the interstate transportation or sale of adulterated and misbranded food or drugs.
Food, Drug, and Cosmetic Act of 1938 (FDCA 1938)
U.S. Food and Drug Administration (FDA) was created under FDCA; required that all new drug applications be filed with the FDA.
Adulteration
- Consisting “in whole or in part of any filthy, putrid, or decomposed substance”
- Prepped, packed, or held in unsanitary conditions
- Containing unsafe color additives
- Claimed to be or represented as drugs recognized in “an official compendium” but differing in strength, quality or purity
Misbranding
- Labeling that is false or misleading
- Packaging that doesn’t have a label containing name and place of business of the manufacturer, packer, distributor or an accurate quantity of content or not clearly labeled with info required by law
- Failure to indicate if product is habit forming on label if it is
- Failure to label adequate directions for use
Durham-Humphrey Act of 1951
All products must have adequate directions for use.
Drugs are separated into 2 categories: legend (prescription) and nonlegend (OTC).
Allows verbal prescriptions over phone
Allows refills to be called in from physician’s office
Kefauver-Harris Amendment of 1962
Requires all medication in US to be pure, safe, and effective
Comprehensive Drug Abuse Prevention and Control Act of 1970
DEA placed under the supervision of the Department of Justice. Controlled substances placed in 1 of 5 schedules based on abuse and accepted medical use
Schedule I
No accepted medical use, extremely high potential for abuse.
Crack, crystal meth, ex, hash, heroin, LSD, weed, mescaline, opium, PCP, peyote, psilocybin, roofies
Schedule II
Has a medical use but has a high abuse potentiality severe psych or physical dependency
Schedule III
Has accepted medical use, and the abuse potential is less than schedule I and II drugs
Schedule IV
Abuse potential is less than schedule III but administration may lead to limited physical or psych dependency
Schedule V
Abuse potential is less than Schedule IV drugs; schedule includes exempt narcotics
Drug Enforcement Agency Registration
Every facility that dispenses controlled drugs must register with DEA by submitting DEA Form 224. Renew every 3 years.
Schedule II Refills:
May be filled partially for up to 60 days from date of issue on the prescription unless discontinued sooner.
Schedule III to V Refills:
Patient may receive up to 5 refills within 6 months on prescription if authorized.
Exempt Narcotics
Select cough and antidiarrheal meds can be purchase if individual is 18yo. Limit on one container in 48hr period.
Poison Prevention Packaging Act of 1970
To reduce accidental poisoning in children
Occupational Safety and Health Act (OSHA) of 1970
Created Occupational Safety and Health Administration (OSHA). Developed to ensure job safety and health standards for employees. Requires usage of MSDS (Material Safety Data Sheets)
Drug Listing Act of 1972
Each drug is assigned 11-digit # to identify it. Known as NDC (National Drug Code). First 5 # identify manufacturer, next 4 # identify drug product, Last 2# represent package size and packaging.
Orphan Drug Act of 1983
Meds for diseases or conditions of which there are fewer than 200,000 cases in the world.
Drug Price Competition and Patent Term Restoration Act of 1984
Encouraged creation of both generic and new medication by streamlining process for generic drug approval and extending patent licenses.
Prescription Drug Marketing Act of 1987
Prohibits reimportation of drug into US by anyone but manufacturer.
