Federal Regulations of Dispensing: Medications Slides Exam 1 Flashcards
What is the timeline order of the acts?
- Pure Food and Drug Act (1906)
- Food, Drug, and Cosmetic Act (1938)
- Durham-Humphrey Amendment (1951)
- Kefauver-Harris Amendment (1962)
- Orphan Drug Act (1983)
- Drug Price Competition Act (1984)
- Prescription Drug User Fee Act (1992)
- Food and Drug Administration Modernization Act (1997)
- Food and Drug Administration Amendments Act (2007)
- Patient Protection and Affordable Care Act (2010)
- Drug Quality and Security Act (2013)
Pure Food and Drug Act
made to provide unalduterated food and drugs to the public
Food, Drug, and Cosmetic Act
- no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA
- expanded the definitions of misbranding and adulteration used in the earlier act, requiring that labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs
Durham-Humphrey Amendment
- Rx vs OTC
- “Caution: Federal law prohibits dispensing without a prescription.”
- authorized oral prescriptions and refills of prescription drugs
Kefauver-Harris Amendment
strengthened the new drug approval process by requiring that drugs be proved not only safe but also effective
Orphan Drug Act
gave manufacturers tax breaks to be able to fund / make drugs that would benefit a small population
Drug Price Competition Act
- Waxman-Hatch; streamlined the generic approval process
- make generic drugs more readily available to the public and, at the same time, provide incentives for manufacturers to develop new drugs
Prescription Drug User Fee Act (PDUFA)
industry pays a fee to have their drugs reviewed
Food and Drug Administration Modernization Act
gave FDA more authority over OTC products
Food and Drug Administration Amendments Act
- Provided the FDA with new funding and significantly more authority over drug safety
- Gave authorization to regulate drug safety (ex. REMS program)
Drug Quality and Security Act
- FDA to oversight large-scale compounding pharmacies
- Those compounding sterile products can register with FDA and must comply with CGMP
- Drug Supply Chain Security Act, adds “track and trace” requirements
What is the rationale for federal drug regulation?
- protect public against adulterated and misbranded drug products
- necessity of balancing “direct regulation” and “indirect regulation
Federal Food and Drug Administration (FDA)
- Housed under the Department of Health and Human Services (DHHS)
- Authority for administering the FDCA
- FDA secretary appointed by President with confirmation of Senate
Office of Medical Products and Tobacco
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research
- Center for Devices and Radiological Health
- Center for Tobacco Products
Functions of FDA
- Rulemaking
- Issue guidance documents
- Incorporate advice from standing advisory committees of outside experts
What Is a Drug?
- Articles recognized in the USP or homeopathic pharmacopeia
- Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (Part B)
- Articles other than food intended to affect the structure or function of the body (Part C)
- Definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body
What are the Special Food Categories?
– Special dietary foods
– Medical foods
– Nutraceuticals and functional foods
The Nutrition Labeling and Education Act + FDAMA
- allow foods to contain health claims if approved by the FDA by regulation or by the “significant scientific agreement” test
- Manufacturer must submit considerable evidence to support the claim to obtain FDA approval
DSHEA
– Created a new special category of food called “dietary supplements” (DSs)
– DSs do not require premarket approval
– DS defined as a vitamin, mineral, herb, or other botanical; amino acid; or substance used to supplement the diet by increasing total dietary intake
What are the types of nutritional claims that DSHEA allows?
– Benefiting a classical nutrient deficiency disease
– Describing role of the DS in affecting the structure/function of the body
– Characterizing the mechanism by which a DS acts to maintain the structure or function
– Statements of general well-being
Labels of dietary supplements must contain what?
disclaimer
How can FDA remove a dietary supplement?
if there is evidence of significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling
Dietary Supplement and Nonprescription Drug Consumer Protection Act
requires manufacturers to report serious adverse events
cosmetic
- topical articles intended for cleansing, beautifying, or altering appearance
- can become a drug if the seller makes a health or structure/function claim
- “Ignorant, unthinking consumer” standard likely applied
USP
– Published by the USPC
– Sets uniform standards
HPUS
Publishes standards for homeopathy products by the HPCUS, a private organization
When must a drug product meet all standards of compendia?
if a drug is recognized in USP or HPUS
FDA Enforcement Authority
- Injunction
- Criminal action
- Seizure of products
- Warning letters
Product Recalls
- FDA cannot directly order recalls; manufacturers have to do that
- there are 3 classes
Adulteration
- Strength, quality, or purity differs from compendia standards, unless plainly stated on label.
- Strength, quality, or purity differs from label.
- Product is adulterated unless manufacturer complies to CGMP.
- Failure to manufacture a product in a tamper-resistant container
Misbranding
- False of misleading labeling
- If label does not include a listing of active ingredients and quantity and list of inactive ingredients (in abc order)
- If label does not contain “adequate directions for use” or “adequate information for use” and “adequate warnings against use” by children and others for whom use might be dangerous
- If a drug imitates another drug
Nonprescription Drug Labeling
- must contain “Drug Facts” panel
- Professional OTC labeling may be published by manufacturers for indications not appropriate for lay diagnosis or treatment
National Drug Code Number
- 10-digit three segment code (4-4-2, 5-3-2, or 5-4-1)
- Billings and claims submissions require an 11-digit NDC number
Drug Advertising
- FDA regulates Rx drug advertising
- FTC regulates OTC drug advertising
- all advertisements must contain “true statement”
True statement
must contain fair balance of good and bad
Drug Advertising: Manufacturer to Consumer
FDA allows manufacturers to apply the “adequate provision” requirement
