Federal Regulations of Dispensing: Medications Slides Exam 1

Question 1

What is the timeline order of the acts?

Answer 1

• 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)

Question 2

Pure Food and Drug Act

Answer 2

made to provide unalduterated food and drugs to the public

Question 3

Food, Drug, and Cosmetic Act

Answer 3

• 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

Question 4

Durham-Humphrey Amendment

Answer 4

• Rx vs OTC
• “Caution: Federal law prohibits dispensing without a prescription.”
• authorized oral prescriptions and refills of prescription drugs

Question 5

Kefauver-Harris Amendment

Answer 5

strengthened the new drug approval process by requiring that drugs be proved not only safe but also effective

Question 6

Orphan Drug Act

Answer 6

gave manufacturers tax breaks to be able to fund / make drugs that would benefit a small population

Question 7

Drug Price Competition Act

Answer 7

• 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

Question 8

Prescription Drug User Fee Act (PDUFA)

Answer 8

industry pays a fee to have their drugs reviewed

Question 9

Food and Drug Administration Modernization Act

Answer 9

gave FDA more authority over OTC products

Question 10

Food and Drug Administration Amendments Act

Answer 10

• Provided the FDA with new funding and significantly more authority over drug safety
• Gave authorization to regulate drug safety (ex. REMS program)

Question 11

Drug Quality and Security Act

Answer 11

• 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

Question 12

What is the rationale for federal drug regulation?

Answer 12

• protect public against adulterated and misbranded drug products
• necessity of balancing “direct regulation” and “indirect regulation

Question 13

Federal Food and Drug Administration (FDA)

Answer 13

• Housed under the Department of Health and Human Services (DHHS)
• Authority for administering the FDCA
• FDA secretary appointed by President with confirmation of Senate

Question 14

Office of Medical Products and Tobacco

Answer 14

• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health
• Center for Tobacco Products

Question 15

Functions of FDA

Answer 15

• Rulemaking
• Issue guidance documents
• Incorporate advice from standing advisory committees of outside experts

Question 16

What Is a Drug?

Answer 16

• 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

Question 17

What are the Special Food Categories?

Answer 17

– Special dietary foods
– Medical foods
– Nutraceuticals and functional foods

Question 18

The Nutrition Labeling and Education Act + FDAMA

Answer 18

• 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

Question 19

DSHEA

Answer 19

– 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

Question 20

What are the types of nutritional claims that DSHEA allows?

Answer 20

– 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

Question 21

Labels of dietary supplements must contain what?

Answer 21

disclaimer

Question 22

How can FDA remove a dietary supplement?

Answer 22

if there is evidence of significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling

Question 23

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Answer 23

requires manufacturers to report serious adverse events

Question 24

cosmetic

Answer 24

• 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

Question 25

USP

Answer 25

– Published by the USPC

– Sets uniform standards

Question 26

HPUS

Answer 26

Publishes standards for homeopathy products by the HPCUS, a private organization

Question 27

When must a drug product meet all standards of compendia?

Answer 27

if a drug is recognized in USP or HPUS

Question 28

FDA Enforcement Authority

Answer 28

• Injunction
• Criminal action
• Seizure of products
• Warning letters

Question 29

Product Recalls

Answer 29

• FDA cannot directly order recalls; manufacturers have to do that
• there are 3 classes

Question 30

Adulteration

Answer 30

• 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

Question 31

Misbranding

Answer 31

• 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

Question 32

Nonprescription Drug Labeling

Answer 32

• must contain “Drug Facts” panel
• Professional OTC labeling may be published by manufacturers for indications not appropriate for lay diagnosis or treatment

Question 33

National Drug Code Number

Answer 33

• 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

Question 34

Drug Advertising

Answer 34

• FDA regulates Rx drug advertising
• FTC regulates OTC drug advertising
• all advertisements must contain “true statement”

Question 35

True statement

Answer 35

must contain fair balance of good and bad

Question 36

Drug Advertising: Manufacturer to Consumer

Answer 36

FDA allows manufacturers to apply the “adequate provision” requirement