Term
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Definition
Estb. FDA
Goal to protect health and safety
Dealt with adulterated and misbranded drugs |
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Term
| Food, Drug and Cosmetic Act |
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Definition
Required drugs to be safe as labeled
Label must contain adequate instructions for use and warnings |
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Term
| Durham-Humphrey Amendment |
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Definition
Established prescription and OTC classes of drugs
Established the federal caution
Establishes requirements for oral and refill prescriptions |
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Term
| Kefauver-Harris Amendment |
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Definition
NDA
Added safety to requirements
Estb. GMPs |
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Term
| Prescription Drug Marketing Act |
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Definition
Restricts pharmacies from receiving or distributing drug samples from manufacturers
Prohibits sale of drug samples by hospitals or other health care entities
Establishes state licensure requirements for pharmaceutical wholesalers |
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Term
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Definition
Streamlined FDA drug approval process to allow expedited availability of drugs and devices
Expands manufacturers’ ability to communicate information regarding off-label uses
Gives FDA full authority to establish labeling requirements for OTC agents |
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Term
| Prescription Drug User Fee Act (PDUFA) |
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Definition
| requires manufacturers to pay fees to FDA for drug approval process; FDA needed money so manufacturers pay FDA to approve their drugs*** |
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Term
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Definition
| expanded access to drugs for rare diseases |
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Term
| Drug Price Competition and Patent Term Restoration Act |
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Definition
| streamlined requirements for bringing generics to market |
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Term
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Definition
| Includes drugs that consist in whole or in part of filthy, putrid, or decomposed substances |
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Term
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Definition
| false or misleading label or labeling |
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Term
| Package insert is required in: |
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Definition
required for products containing estrogens, DES, oral contraceptives and intrauterine contraceptive devices
Also req. for Accutane, Lariam, all antidepressants |
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Term
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Definition
| Written, printed, or graphic matter upon the immediate container of any article |
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Term
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Definition
| includes information on label and all other written, printed, or graphic matter upon any article or any of its containers or wrappers (includes package insert) |
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Term
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Definition
| USP, official homeopathic pharmacopoeia of US, National Formulary |
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Term
| Are supplements over the counter drugs? |
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Definition
| No, because otc drugs are approved by the FDA. |
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Term
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Definition
| Food, not a drug (versus parenteral nutrition which medicare part d will pay for) |
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Term
| Timeline for reporting of serious adverse effects |
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Definition
| information must be submitted to FDA within 15 days of event and new medical developments within the first year of the event |
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Term
| Information that OTC products must contain |
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Definition
| info. related to warnings to stop use, phone number for consumers to call, dosages and patient population intended, and route of administration and time of administration |
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Term
| Rx must contain information including: |
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Definition
| type of container used to dispense and Federal Caution |
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Term
| Current Good Manufacturing Practices (CGMPs) |
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Definition
| FDA regulations that establish minimal requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product |
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Term
| Manufacturer Compliance with CGMPs and FDA Registration |
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Definition
| Manufacturer registration with FDA valid for two years and FDA will inspect one time within the two year period |
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Term
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Definition
Drug not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the labeling
Must be used for a “material” amount of time for indications in the labeling
Sometimes applies to new drugs for different indications, forms, etc |
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Term
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Definition
| within 30 days, then drug moves to clinical trials |
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Term
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Definition
| examines adverse effects in small studies, toxicity, metabolism, bioavailability, elimination and other pharmacological effects |
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Term
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Definition
| tested for efficacy on patients with the disease/condition |
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Term
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Definition
| large clinical trials for safety and efficacy |
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Term
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Definition
| post-marketing surveillance |
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Term
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Definition
| Used for individuals with serious or life-threatening injuries meeting following requirements |
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Term
| OTC drugs generally have these characteristics: |
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Definition
their benefits outweigh their risks
the potential for misuse and abuse is low
consumer can use them for self-diagnosed conditions
they can be adequately labeled
health practitioners are not needed for the safe and effective use of the product |
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