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LAWS
Term | Definition |
---|---|
Pure Food and Drug Act (1906) | *Prohibits interstate commerce of misbranded and adulterated drugs and foods. |
Federal Food Drug and Cosmetic Act (1938) | *Drug regulation |
Durham-Humphrey Amendment (1951) | *Defines 2 categories *Legend drugs(prescription only)- must indicate :Caution:Federal law prohibits dispensing without a prescription *Over the Counter (OTC) *(Humpty was a legend) |
Kefauver-Harris Amendment (1962) | *Medication needs to be safe and effective *Prior manufactures only had to prove that a drug was safe (not misbranded or adulterated) |
Controlled Substance Act (1970) | *regulates the manufacture, importation, possession and distribution of controlled substance |
Schedule I (C-I) | *C-I drugs high potential for abuse and physical/dependence *Has no accepted medical use *Examples - heroin, Marijuana |
Schedule II (C-II) | *C-II high potential for abuse *Medically acceptable *Examples include most narcotics and stimulants |
Schedule III (C-III) | *C-III moderate to low potential for physical dependence *Examples anabolic steroids, buprenorphine, certain codeine |
Schedule IV (C-IV) | *Low potential for abuse *Examples alprazolam, zolpidem |
Schedule V (C-V) | *Low potential for abuse *Examples antidiarrheals antitussives |
Schedule II (C-II) | *No refills * transfers prohibited |
Schedule III-IV | *Up to 5 refills in 6 months *Transfers allowed one time |
Poison Prevention Packaging Act (1970) | *Drugs must be packaged in child-resistant containers *Exempt- Sublingual nitroglycerin, effervescent, contraceptives |
Omnibus Budget Reconciliation Act (OBRA) (1990) | *Drug Utilization Review (DUE) *Patient Counseling *Patient Record Maintenance |
Health Insurance Portability and Accountability Act (HIPAA) (1996) | *Limits the use and disclosure of protected health information |
Food and Drug Administration Modernization Act (1997) | *Eliminates requirements "Caution: Federal law prohibits dispensing without a prescription" May be stated as "Rx only" |
Drug Addiction Treatment Act (2000) | *Allows qualified prescribers to complete training and register for a Addiction DEA number DEA will start with the letter X |
Combat Methamphetamine Epidemic Act (2005) | *Regulates the sale of over the counter products containing pseudoephedrine *Present valid ID |
Pseudoephedrine | *Customer purchases limits *Daily limit 3.6 grams/day *9 grams per 30 days if purchased in-store *7.5 grams per day via mail |
Tall-Man Lettering | *Mixed-letter to emphasize the difference in drug names that look alike or sound alike |