Term
| Explain what is meant by the drug standards |
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Definition
| Rules set assure consumers that they get what they pay for. The law says that all preparations called by the same drug name must be of uniform strength, quality, and purity. |
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Term
| Name the first drug law passed in this country for consumer safety, and give the year it was passed |
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Definition
| 1906 Pure Food and Drug Act |
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Term
| Summarize the provisions of the Federal Food, Drug, and Cosmetic Act of 1938, and identify the government agency that enforces the act |
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Definition
- All labels muct be accurate and list all active and inactive ingredients
- New products must be approved by FDA
- Warning labels must be labeled with the legend (legend drug)
- Prescription and nonprescription drugs must be shown t obe effective as well as safe
- FDA enforces the above
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Term
| Interpret what is meant by USP/NF |
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Definition
- United States pharmacopeia/National Formulary
- U.S. standard reference for making each drug
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Term
| Summarize the provisions of the Controlled Substance Act of 1970 |
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Definition
- Isolated the abused and addicting drugs into five levels/schedules (C-1, C-2, C-3, C-4, C-5)
- Demanded security of controlled substances
- Set limitations on the use of prescriptions
- Demanded that each prescriber register with DEA and obtain DEA number to present on prescription
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Term
| Explain what is meant by a DEA number |
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Definition
| Registration and identification number |
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Term
| Define schedules of controlled substances, and differentiate between C-I to C-V schedules |
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Definition
- C-1 - High abuse potential, not aprroved for medical use
- C-2 - Writeen Rx only, no phone in, no refills without new written prescription.
- C-3 - Written faxed or verbal (phoned in) prescription by physicians only, refillable 5x in 6 months
- C-4 - Phoned in by health care practitioner but needs Physician signature, refilable 5x in 6 months
- C-5 - Over the counter, unprescribed.
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Term
| State several responsibilities you have in the dispensing of medications, as a direct result of the three major drug laws described in this chapter |
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Definition
- Keep a current drug reference book
- Keep controlled substance locked
- keep accurate records
- Conceal and secure prescription pads
- Keep tab of FDA/DEA activities
- Establish working rapport with the local pharmacist
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Term
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Definition
- Those that were being abused by society
- Depressants, stimulants, psychedelics, narcotics, and anabolic steroids
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Term
| Drug Enforcement Administration (DEA) |
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Definition
- Bureau of the department of Justice to enforce control on controlled substance
- Concered with controlled substances only
- Monitors need for chaging the schedules of abused drugs
- Enforces law against drug activities, including illegal drug use, dealing and manufacturing
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Term
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Definition
| All preparations called by the same drug name must be of uniform strength, quality, and purity |
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Term
| Food and Drug Administration (FDA) |
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Definition
- Established more specific regulations to prevent adulteration of (tampering with) drugs, foods, and cosmetics
- Concerned with general safety standards
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Term
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Definition
| 1983 Orphan Drug Act give pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people |
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