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Pharmacy Law & DEA
Laws & Acts
| Question | Answer | and... | also... |
|---|---|---|---|
| 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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