Term
| Pure Food and Drug Act of 1906 |
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Definition
-first major legislation in the US to regulate drugs
-focused on matiching the claims of the producer w/ chemical standards of the product
-drugs were defined according to standards of strength, quality, and purity
-USP and National Formulary
-food or drug label could not be false or misleading in any particular
-misbranding was the source of considerable controversy in the regulation of drugs |
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Term
Pure Food and Drug Act of 1906
what it regulated |
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Definition
-standards of strength
-quality
-purity |
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Term
| Food, Drug, and Cosmetic Act of 1938 |
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Definition
-required drugs be labeled w/ adequate directions for safe use
-irrefutably prohibited false therapeutic claims for drugs
- new feature it regulated: safety (premarket approval) |
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Term
| Durham-Humphrey Act of 1951 |
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Definition
-basis: objective definition of prescription drugs
-new feature it regulated: defined what drugs were prescription drugs
-bear prescription legend
-no refill w/o specific authorization from MD
-manufacturers still decided if a product was prescription or nonprescription |
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Term
| Kefauver-Harris Amendment (1962) to the Food, Drug, and Cosmetic Act of 1938 |
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Definition
- why: Thalidomide experience in Europe
-stipulates a drug must prove useful before marketing
-required all antibiotics be certified
-gave FDA control over Rx drug advertising |
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Term
Kefauver-Harris Amendment (1962)
new features it regulated |
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Definition
-manufacturers must prove efficacy before marketing
-manufacturers must prove drug fulfills claims
-testing procedures subjecto to FDA regulation
-FDA can end or order changes to investigations
-(did not deal w/drugs on market before 1962) |
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Term
| NAS-NRC Drug Effectiveness Study (1966) |
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Definition
-evaluate drug efficacy for those introduced between 1938-1962
-primary focus on Rx drugs
-~500 OTCs studied
-almost 1100 products removed from the market
-each claim for a Rx drug was separately evaluated leading to drug's efficacy |
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Term
| FDA OTC Evaluation Study (1972 - present) |
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Definition
-review safety and efficacy of OTC ingredients, doses, formulations, and labeling used in meds available to consumers w/o an Rx
-review the 500 ingredients composing these products for safety and efficacy
-a monograph is a regulatory standard for ingredients
-specifies acceptable ingredients, doses, formulations, indications, and labeling
-any OTC medicine that conforms to the monograph may be manufactured
-does not require an individual product license
-panel put them into categories I-III
-not yet complete |
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Term
FDA OTC Evaluation Study (1972 - present)
categories |
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Definition
-category I: safe, effective, and not misbranded
-category II: unsafe, ineffective, or misbranded
-category III: cannot be classified in either category I or II due to insufficient data |
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Term
| Dietary Supplement Health and Education Act of 1994 |
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Definition
-defined "dietary supplements" as a separate regulatory category
-definition of "dietary supplement" included vitamins; minerals; herbs or other botanicals; Aas; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredient |
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Term
Dietary Supplement Health and Education Act of 1994
what FDA can regulate |
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Definition
-FDA can ban an ingredient if proven unsafe
-dietary supplements cannot make drug claims |
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Term
Dietary Supplement Health and Eduaction Act of 1994
what FDA cannot regulate |
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Definition
-manufacturers not required to submit safety info before marketing
-no adverse event reporting required
-cannot ban dubious supplement ingredients as "unapproved food additives" |
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Term
| The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 |
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Definition
-requires manufacturers of dietary supplements and OTCs to notify FDA about serious adverse events
-death, life-threatening experiences, inpatient hospitalizations, persistent or significant disability or incapacity, birth defects, or the need for medical intervention to prevent any such problems
-basis: FDA had difficulty banning ephedra sales despite widespread adverse events |
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Term
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Definition
| OTCs w/ no dose limit or greater than 3 years stability are exempt from needing to include an expiration date |
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Term
| Methamphetamine precursor regulation |
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Definition
-3.6 g/day regarless of number of transactions
-blister packs: no more than 2 dosage units per blister
-liquids: unit dose packets or pouches
-behind the counter or in locked cabinet
-check ID of buyer & log sales
-keep log for 2 years
-require & certify employee training
-mobile retail/mail order
-30 day limit of 7.5 g to an individual
-30 day purchase limited to 9 g
-max 7.5 g by common/contract carrior or USPS
-WI: pseudoephedrine limit of 7.5 g in 30 days |
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Term
| dietary supplement definition |
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Definition
-intended to supplement the diet
-intended for ingestion in pill, capsule, tablet, or liquid form
-not represented for use as a conventional food or as the sole item of a meal or diet
-labeled as a "dietary supplement" |
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Term
| dietary supplement labeling |
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Definition
-claims must be accurate and truthful
-NO disease claims
-structure/function claims allowed (notify FDA w/in 30 days)
-normal role in the body claims allowed
-claims about classical nutritional deficiencies or disease prevalence are allowed
-herbal products must specify from which part of the plant it is taken |
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Term
| homeopathy labeling requirements |
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Definition
-ingredients list
-instructions for safe use
-at least one major indication
-dilution |
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Term
| reasons for product recall |
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Definition
-adulteration
-misbranding
-unacceptable risk |
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Term
| classes of product recall |
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Definition
-class I: dangerous or defective products that predictably could cause health problems or death
-class II: products that might cause a temporary health problem, or pose only a slight threat of a serious nature
-class III: products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations |
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Term
Civil liability and OTCs:
Pharmacist liability |
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Definition
all 4 must be proven:
-defendant owed plaintiff duty of care
-defendant breached that duty of care
-the breach caused the injury
-plaintiff sustained a cognizable injury or damage |
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