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Pharmacy laws
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| DEA form 41 | Submission of the destruction of outdated/damaged controlled substances |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 |
Created by:
rrsewell611
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