Pharmacy Technician Laws
Study online at https://quizlet.com/_hu712c
1. Food, Drug Administration Act 1938: Prescription only instead of legend phrase.
2. Food, Drug, And Cosmetic Act (FDC) 1938: Created FDA and required manufacturers to file new
drugs before marketing. Determined whether to label a drug prescription or non prescription.
3. Kefauver- Harris Amendment 1962: requires that drugs not only be safe for humans, but also
effective.
4. Orphan Drug Act 1983: Encourages development of new drugs to treat rare diseases by providing tax
incentives and fast review.
5. Pure Food and Drug Act 1906: Prohibits interstate transportation and sale of adulterated or misbrand-
ed food and drugs.
6. Durham- Humphrey Amendment 1951: Federal law prohibits dispensing without script; distin-
guished between legend/OTC drugs, limited refills.
7. 1914 Harrison Tax Act: Established that manufacturers, pharmacists, importers, and physicians prescrib-
ing narcotics are licensed and taxed.
8. Poison Prevent Packaging Act 1970: Requires child-proof packaging on all controlled and most
prescription drugs dispensed by pharmacies. Non-child-proof containers may only be used if the prescriber or patient
requests one.
9. Controlled Substance Act 1970 (CSA): Federal legislation designed to improve the regulation,
manufacture, distribution, and dispensing of drugs that are either narcotics or likely to be misused.
10. Drug Price Competition and Patent- Term Restoration Act 1984 (HATCH-
WAXMAN): Encouraged quicker introduction of both generic and new drugs and extension of patent terms.
11. The Thalidomide Lesson: In 1962 a new sleeping pill was found to cause severe birth defects when
used by pregnant women. From then on drugs needed to be safe and effective before marketed.
12. Omnibus Budget Restoration Act 1990: Requires offer of counsel to Medicare patients regard-
ing their medications.
13. Exempt narcotics: medications that contain habit forming ingredients, but can be sold by a pharmacist
without a prescription to person 18 or older with 48 hour dosage limits with records maintained in a bound book.
14. Health Insurance Portability and Accountability Act 1996: Established safeguards to
protect patient confidentiality, to keep insurance when moving to new job.
15. Combat Methamphetamine Epidemic Act of 2005: Reclassifies and restricts access to
products containing pseudo ephedrine.
16. Dual Marketing Status: 17 years old and younger need a prescription but 18 and over it is OTC (Example:
Plan B emergency contraceptives.)
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Study online at https://quizlet.com/_hu712c
1. Food, Drug Administration Act 1938: Prescription only instead of legend phrase.
2. Food, Drug, And Cosmetic Act (FDC) 1938: Created FDA and required manufacturers to file new
drugs before marketing. Determined whether to label a drug prescription or non prescription.
3. Kefauver- Harris Amendment 1962: requires that drugs not only be safe for humans, but also
effective.
4. Orphan Drug Act 1983: Encourages development of new drugs to treat rare diseases by providing tax
incentives and fast review.
5. Pure Food and Drug Act 1906: Prohibits interstate transportation and sale of adulterated or misbrand-
ed food and drugs.
6. Durham- Humphrey Amendment 1951: Federal law prohibits dispensing without script; distin-
guished between legend/OTC drugs, limited refills.
7. 1914 Harrison Tax Act: Established that manufacturers, pharmacists, importers, and physicians prescrib-
ing narcotics are licensed and taxed.
8. Poison Prevent Packaging Act 1970: Requires child-proof packaging on all controlled and most
prescription drugs dispensed by pharmacies. Non-child-proof containers may only be used if the prescriber or patient
requests one.
9. Controlled Substance Act 1970 (CSA): Federal legislation designed to improve the regulation,
manufacture, distribution, and dispensing of drugs that are either narcotics or likely to be misused.
10. Drug Price Competition and Patent- Term Restoration Act 1984 (HATCH-
WAXMAN): Encouraged quicker introduction of both generic and new drugs and extension of patent terms.
11. The Thalidomide Lesson: In 1962 a new sleeping pill was found to cause severe birth defects when
used by pregnant women. From then on drugs needed to be safe and effective before marketed.
12. Omnibus Budget Restoration Act 1990: Requires offer of counsel to Medicare patients regard-
ing their medications.
13. Exempt narcotics: medications that contain habit forming ingredients, but can be sold by a pharmacist
without a prescription to person 18 or older with 48 hour dosage limits with records maintained in a bound book.
14. Health Insurance Portability and Accountability Act 1996: Established safeguards to
protect patient confidentiality, to keep insurance when moving to new job.
15. Combat Methamphetamine Epidemic Act of 2005: Reclassifies and restricts access to
products containing pseudo ephedrine.
16. Dual Marketing Status: 17 years old and younger need a prescription but 18 and over it is OTC (Example:
Plan B emergency contraceptives.)
1/2
