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Pharmacy Law & DEA

Laws & Acts

Omnibus Budget Reconciliation Act of 1990 (OBRA-90) Req's pharmacists to offer patient counseling to every patient/new script. Req's MFG to provide the lowest prices to any customer or medicaid patient.
Anabolic Steroids Act of 1990 Helped stiffen regulations on abuse/misuse of anabolic steroids by athletes.
Dietary Supplement Health & Education Act of 1994 (DSHEA) Provides definitions & guidelines on supplements. MFG's can make claims w/regard to general health promotion, but not diseases.
Kefauver-Harris Amendment of 1963 Req's all meds on the market in the US to be pure, safe & effective.
Comprehensive Drug Abuse Prevention & Control Act of 1970 DEA was created & placed under Dept. of Justice. Created controlled substance schedules.
Durham-Humphrey Act of 1951 Established a distinction between OTC & RX meds. "Caution: federal law prohibits dispensing without script." Authorized verbal RX scripts.
Pure Food & Drug Act of 1906 Prohibits transportation or sale of adulterated & misbranded food or drugs.
Harrison Narcotic Act of 1914 No longer able to obtain opium without a prescription.
Food, Drug & Cosmetic Act of 1938 (FDCA) All food & drug products must prove safe for human consumption. FDA was created All new drug apps must be filed w/FDA.
Poison Prevention Packaging Act of 1970 Req's most OTC & legend drugs to have childproof caps. (80% of kids under age 5 cannot open them, 90% of adults can).
Drug Listing Act of 1972 Each drug is assigned a specific 11-digit # known as an NDC#. (1st 5 digits identify MFG. Next 4 identify drug product. Final 2 represent pkg size & packaging).
Occupational Health & Safety Act of 1970 (OSHA) Ensures a safe & healthy workplace for all employees, maintains a reporting system for job related injuries, and reduce workplace hazards. Req'd Material Safety Data Sheets (MSDS).
Orphan Drug Act of 1983 Meds for cases that affect less than 200,000 individuals. Offers tax cuts & incentives to MFG's who develop & market orphan drugs.
Prescription Drug Marketing Act of 1987 Prohibits reimportation of a drug into the US by anyone except MFG's. Req's vets to write RX's. Req's label for meds administered to animals: "federal law restricts this drug to use by or on an order of a licensed vet."
DEA form used to destroy controlled substances 41
DEA form used to report theft of a controlled substance 106
DEA form used to order C-II meds 222
How often may one purchase an exempt narcotic? every 48 hours
How many different C-II's may be ordered at one time? 10
What age must one be to be able to purchase an exempt narcotic? 18
Health Insurance Portability & Accountability Act of 1996 (HIPAA) Protects patient privacy. Req's every pharmacy to provide HIPAA training. Deals w/pt's rights to continuing health insurance, even when changing employers (transition).
Verifying a DEA# (AB1234563) 1st letter is A, B, or M; 2nd letter is 1st letter of prescribers last name; add 1st, 3rd & 5th #'s; add 2nd, 4th & 6th #'s then X by 2; add two sums together = last digit of sum (33[3]) should match last # in DEA set AB1234563
Created by: mistymu



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