|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|DEA form 41||Submission of the destruction of outdated/damaged controlled substances|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