Important laws

Term Definition
Food and Drug Administration (FDA) Deals directly with the manufacture and review of the medications.
Pure Food and Drug Act Prohibits the interstate distribution or sale of adulterated/misbranded food or drugs
The Food, Drug and Cosmetic Act (FD&C) Requires proper labeling/branding of products.
Requires what is inside the container be the same as what it is labeled to be.
Durham-Humphrey Amendment Prohibited dispensing of legend drugs without a prescription. "Caution: Federal law prohibits dispensing this medication without a prescription."
Kefauver-Harris Amendment Required: all medications, Rx and non-Rx, be pure effective and safe to use on humans. And all manufacturers to register and allow inspection of manufacturing sites.
Controlled Substances Act (CSA) Requires pharmaceutical industry to keep records and maintain security measures for certain medications.
Divides controlled substances into 5 schedules.
Drug Enforcement Agency (DEA) Regulatory agency for anything relating to controlled drugs
Schedule I LSD, Crack, Mescaline, Heroin, Marijuana*
Schedule II Amphetamines (Ritalin, Concerta, Adderall, Percocet, Fentanyl) Methadone.
Schedule III Combination narcotics
ie: Tylenol #3
Schedule IV Benzodiazepines (lorazepam, alprazolam), Hypnotics (zolpidem, Ambien)
Schedule V Cough preps with codeine
ie: Robitussin AC
DEA form 222 Ordering of schedule II drugs
DEA form 41 Submission of the destruction of outdated/damaged controlled substances
DEA form 106 Discovery of theft of controlled substances
Poison Prevention Packaging Act Created standards for child-resistant packaging
Occupational Safety and Healthy Act (OSHA) Established to prevent workpace disease and injury:
MSDS, eyewash stations, Biohazard bins, SHARPS containers
Drug Listing Act (NDC code) Assigns a unique and permanent drug code to each medication. Identifies: Manufacturer, Medication, Size/Type of packaging. 11digits long.
Federal Hazardous Substance Act The use and disposal of hazardous material in the pharmacy (mainly in settings where IV solutions are prepared)
Orphan Drug Act Offer financial incentives to orgs. that develop and manufacture "orphan" drugs.
Drug Price Competition and Patent Term Restoration Act Extended patent license.
lower cost of drug prices, encourage creation of new meds
Prescription Drug Marketing Act Prohibits the sale/distribution of samples to anyone other than those who are licensed to prescribe them. And the reimportation of a drug into the U.S. by anyone but manufacturer
Omnibus Budget Reconciliation Act (OBRA) Require pharmacists to offer counseling to patients, as well as perform drug utilization reviews. (Medicaid/Medicare)
Anabolic Steroids Control Act Allows CSA to regulate anabolic steroids. Became a III scheduled drug.
Health Insurance Portability and Accountability Act (HIPAA) Privacy, security, and transaction regulations/standards.
FDA Modernization Act to Reform the regulation of cosmetics, food, and medical products. Safe pharmacy compounding and regulation of medical devices.
Requires labels of legend drugs to say "Rx Only"
Medicare Rx Drug, Improvement, and Modernization Act of 2003 Provide voluntary prescription drug benefits to patients eligible for Medicare. (Medicare pt. D)
Combat Methamphetamine Epidemic Act Limits amount of ephedrine/pseudoephedrine:
3.6g per person/purchase
7.5g per month

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