What is the legal definition of a DRUG?
- Its recognized by the official compendium
- …intended for diagnosis, cure, mitigation, treatment, prevention…
- …intended to affect the body
HAVE TO HAVE ALL 3
What are the official compendia
- USP
- USP-NF
- HPUS
What does the United States Pharmacopeia [USP] contain?
- Monographs that have definitions, descriptions, and standards for all aspects of a drug [strength, quality, purity, packaging…]
- Also sterile and non-sterile
What does the USP-NF contain?
- Drug standards within the US for substances, products, excipients, supplements
What does the HPUS conatain?
- Standard over homeopathic products [drugs that aren’t treated like USP-NF]
What is the definiation of a Prescription Drug?
- A drug that is NOT safe (due to toxicity or harmful SE) that needs the supervision of a practitioner
Basically a drug given by a doctor
What is something that is a must to have on a prescription drug label?
- “Rx Only”;
- “Prescription Only”;
- “Caution: Federal law prohibits dispensing without prescription”
What is the definiation of a Over-The-Counter Drug?
- A drug that IS safe and DOES NOT need the supervision of a practitioner
Opposite of a Prescription Drug
What is the definiation of a Behind-The-Counter Drug?
- Drugs that are available without a prescription AFTER talking with the pharmacist
- i.e.; Pseudoephidrine
What is the definition of an Orphan Drug?
- Drug that is intended for those with rare disease [< 200,000] OR those in which making the drug is to costly [> 200,000]
What is the definiation of a Dietary Supplement?
- a product that helps supplement the diet that contains one or more vitamins, minerals, herbs, amino acids
- NOT A DRUG
What is the definition of a New Drug?
- Drug NOT seen as safe and effective in dosage form picked OR
- Drug IS seen as safe and effective BUT not been used in dosage form for long periods of time
What is a Grandfathered Drug?
- Drug that was made before 1938 and was still on the market in 1962 [Digoxin, Codeine, Phenobarbital]
- Assumed safe and effective b/c longevity
What is the definition of DESI?
- Drug made between 1938 and 1962
- Assumed safe NOT effective [effectiviness wasn’t required]
- Had to prove EFFECTIVINESS to keep selling
What is the definition of New Drug Appilication [NDA]?
- Sent to FDA once all data and clinical trials have been completed for a new drug to have it approved for marketing
What is the definition of Investigational New Drug Application [IND]?
- Sent to the FDA to exempt from NDA requirements
New drugs aren’t safe and effective yet; thats why we do this first before NDA
What is the definition of Abbreviated New Drug Application?
- Used by generic manufacturers to show bioequivalance
No need for NDA since they are copying NDA-approved drug
What is the definition of Brand Name?
- Name given by the manufacturer
What is the definition of Generic Name?
- Established name in the law
What is the definition of Label in pharmacy law?
- Any printed, written, graphic material on a product container
What is the definition of Labeling in pharmacy law?
- ALL LABELS on the container, wrapper, or accompanying product.
What is the definition of Special Packaging?
- Packaging that is made difficult to open for childern 5 years and younger
- Adults SHOULD be able to open
- Kids under 5 MIGHT be able to get it but it stops them getting in a reasonable time
What is the definition of Pharmaceutical Equivalents?
- Products with same active ingredents, dosage forms, and strength
- May differ by; look, mechanism, expiration, labeling…
What is the definition of Theraputic Equivalent?
- Pharmaceutical Equivalents that have the same clinical and safety profile
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Reading 118
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Reading 228
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Reading 532
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Reading 626
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Reading 737
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Reading 818
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Reading 921
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Reading 1033
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Reading 1118
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Reading 1228
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Reading 1323
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Reading 1419
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Reading 1531
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Reading 1628
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Reading 17/18 (IC 25-26)61
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Reading 19/20 (IAC)55
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Reading 21 (IC, IAC 2, IAC 4, IAC 5, IAC 7, Hormonal Contraceptive Prescribing)12
