Important laws
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| Food and Drug Administration (FDA) | Deals directly with the manufacture and review of the medications.
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| Pure Food and Drug Act | Prohibits the interstate distribution or sale of adulterated/misbranded food or drugs
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| 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.
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| Durham-Humphrey Amendment | Prohibited dispensing of legend drugs without a prescription. "Caution: Federal law prohibits dispensing this medication without a prescription."
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| 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.
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| Controlled Substances Act (CSA) | Requires pharmaceutical industry to keep records and maintain security measures for certain medications.
Divides controlled substances into 5 schedules.
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| Drug Enforcement Agency (DEA) | Regulatory agency for anything relating to controlled drugs
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| Schedule I | LSD, Crack, Mescaline, Heroin, Marijuana*
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| Schedule II | Amphetamines (Ritalin, Concerta, Adderall, Percocet, Fentanyl) Methadone.
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| Schedule III | Combination narcotics
ie: Tylenol #3
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| Schedule IV | Benzodiazepines (lorazepam, alprazolam), Hypnotics (zolpidem, Ambien)
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| Schedule V | Cough preps with codeine
ie: Robitussin AC
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| DEA form 222 | Ordering of schedule II drugs
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| DEA form 41 | Submission of the destruction of outdated/damaged controlled substances
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| DEA form 106 | Discovery of theft of controlled substances
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| Poison Prevention Packaging Act | Created standards for child-resistant packaging
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| Occupational Safety and Healthy Act (OSHA) | Established to prevent workpace disease and injury:
MSDS, eyewash stations, Biohazard bins, SHARPS containers
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| Drug Listing Act (NDC code) | Assigns a unique and permanent drug code to each medication. Identifies: Manufacturer, Medication, Size/Type of packaging. 11digits long.
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| Federal Hazardous Substance Act | The use and disposal of hazardous material in the pharmacy (mainly in settings where IV solutions are prepared)
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| Orphan Drug Act | Offer financial incentives to orgs. that develop and manufacture "orphan" drugs.
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| Drug Price Competition and Patent Term Restoration Act | Extended patent license.
lower cost of drug prices, encourage creation of new meds
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| 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
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| Omnibus Budget Reconciliation Act (OBRA) | Require pharmacists to offer counseling to patients, as well as perform drug utilization reviews. (Medicaid/Medicare)
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| Anabolic Steroids Control Act | Allows CSA to regulate anabolic steroids. Became a III scheduled drug.
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| Health Insurance Portability and Accountability Act (HIPAA) | Privacy, security, and transaction regulations/standards.
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| 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"
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| Medicare Rx Drug, Improvement, and Modernization Act of 2003 | Provide voluntary prescription drug benefits to patients eligible for Medicare. (Medicare pt. D)
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| Combat Methamphetamine Epidemic Act | Limits amount of ephedrine/pseudoephedrine:
3.6g per person/purchase
7.5g per month
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