Term
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Definition
| Article that is USP recognized for use in diagnosis, cure, treatment, or prevention of disease in man or animal |
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Term
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Definition
| Any drug that may be dispensed only upon a prescription (label bears "Rx Only") or injectable drug |
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Definition
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Definition
| Pharmacy or laboratory that sells drug at retail pricing |
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Term
| Virtual wholesale distributor |
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Definition
| Any person engaged in whole distribution of dangerous drugs into or out of Ohio. Has title to the drugs but does not take physical possession of them |
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Term
| Third party logistics provider |
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Definition
| Company contracted with a manufacturer to provide warehousing, distribution, or other services but does not take title of prescription drugs or have responsibility for their sale or disposition |
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Definition
| Sale in which the purpose of the purchaser is to resell the article purchased |
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Term
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Definition
| If a pharmacy sells more than 5% of what they buy to someone other than their patients, they need a wholesaler's license. (Less than 5% = occasional sale) |
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Term
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Definition
| Drug that is habit forming or unsafe for use except under the supervision of a practitioner |
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Definition
| Label that reads "Rx Only" or "Federal Law Prohibits Dispensing Without a Prescription" on the stock bottle |
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Term
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Definition
| Licensed health care professional authorized to prescribe drugs |
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Term
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Definition
| Drug that is not a dangerous drug (OTCs, etc.) |
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Term
| 1906 Pure Food and Drug Act |
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Definition
| Prohibited the interstate commerce of adulterated food and drugs |
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Term
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Definition
| Prohibited false and misleading claims for drug products |
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Term
| 1938 Federal Food, Drug and Cosmetic Act |
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Definition
| Required scientific proof of safety before a drug could be marketed |
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Term
| 1951 Durham-Humphrey Amendments |
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Definition
| Created two classes of drug products, prescription and OTC. (Created "legend drugs") |
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Term
| 1962 Harris-Kefauver Amendments |
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Definition
| Required scientific proof of efficacy for drug products |
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Term
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Definition
| Gave economic and tax incentives for pharmaceutical manufacturers to develop drugs for rare diseases |
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Term
| 1984 Drug Price Competition and Patient Restoration Act |
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Definition
| Created the ANDA for generic drugs (only have to prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting for approval |
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Term
| Prescription Drug Marketing Act of 1984 |
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Definition
| Created regulation of samples, prohibited re-importation of drugs from other countries, and regulated who hospitals can sell drugs to |
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Term
| 1994 Dietary Supplement Health and Education Act |
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Definition
| Made herbal products officially dietary supplements and required the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." |
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Term
| Medication therapy management (MTM) |
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Definition
| Distinct group of services intended to optimize therapeutic outcomes of a patient |
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