Sources of Law, Rules, & Regs

Question 1

Pure Food & Drug Act 1906

Answer 1

Prohibited foods and drugs that we distributed through interstate commerce to be adulterated or misbranded.

• Didn’t require manufactures to list ingredients or directions on label.
• Didn’t regulate cometics or medical devices

Question 2

Food Drug & Cosmetic Act 1938 (FDCA)

Answer 2

Required any new drug couldn’t be marketed unless proven safe according to label directions.

Required label to include adequate directions for use and warnings for habit forming products.

Question 3

Food Drug & Cosmetic Act - Drugs impacted?

Answer 3

Anything after passed - others were grandfathered

• Levothyroxine
• Nitroglycerine
• Digoxin
• Phenobarbital

Question 4

Durham-Humphrey Amendment 1951

Answer 4

Establish prescription and non prescription classes of drugs.

Provided for oral prescriptions and refills

Question 5

OTC Medications are…

Answer 5

Medications that don’t require medical supervision

Question 6

Prescriptions Medications are…

Answer 6

Require medical supervision - Need “Rx Only” on the label.

Question 7

Kefauver-Harris Amendment 1962

Answer 7

Response to thalidomide

Required all new drugs market in US to be not only safe, but effective.

Required informed consent of research individuals

Question 8

Regulating Prescription drug advertising is owned by…

Answer 8

FDA

Question 9

Regulating Non-Prescription drug advertising is owned by…

Answer 9

FTC

Question 10

Good Manufacturing Practices were established by?

Answer 10

Kefauver-Harris Amendment

Question 11

Medical Device Amendment 1976

Answer 11

Provided classification of medial devices, establishment of performance standard, pre-market approvals to ensure meetings GMPs.

Question 12

Orphan Drug Act 1983

Answer 12

Provided tax and licensing incentives to manufacturers developing drugs for a rare disease.

Question 13

Drug Price Competition & Patent-Term Restoration Act

Answer 13

AKA: Hatch-Waxman Amendment

Resolved dispute between brand and generic manufacturers

1. Created Abbreviate New Drug Approval (ANDA) process for generic companies – Needing to only prove bioequivalence.
2. Gave brand manufacturers an additional 5 months of patent protection.

Question 14

Prescription Drug Marketing Act 1987

Answer 14

Placed more stringent controls on distribution.

• Required wholesalers to be licensed.
• Banned re-importation
• Banned sale, trade, purchase of drug samples
• Specified storage/handle requirements and record keeping of samples.
• Prohibited the resale of prescription drugs by health care facilities & hospitals.

Question 15

FDA Modernization Act 1997

Think NDA and Labeling

Answer 15

Broad legislation

Drug Approval

1. Provided “Fast track” provision for new drug applications.
2. Clarified conditions pharmacist can undergo extemporaneous compounding in - exempt from GMPs & new drug application
3. Encouraged supplemental NDA’s to improve research and additional 6 month of patent protection for pediatric studies.

Manufacturer Labeling

1. Change label verbiage to “Rx Only”
2. Eliminated “Warning- May be habit forming” verbiage

Question 16

Patient Protection & Affordable Care Act (2010)

Answer 16

Requires all individuals to have health insurance

Requires standards for financial & administrative transactions - focused on timely transparent claims.

Stops agreements b/t brand and generic manufacturers to limit competition.

Phased elimination of the “donut hole” (catastrophic threshold).

Removed ability for insurance to deny on pre-existing conditions.

Question 17

“Women’s Preventative Health Care Amendment (part of ACA)

Answer 17

Provided services for:

Well women visits
Gestational diabetes screening
HPV screening
STD counseling
HIV counseling & screening
Contraceptive counseling

Question 18

Official Compendia of US

Tell me about it…

Answer 18

US govt DOES NOT publish it. - Published by US Pharmacopoeia Convention (USPC)

Contains monographs of recognized drugs w/ chemical characteristics & quality standards

USP/NF - US pharmacopoeia/National Formulary - ARE TWO SEPARATE ENTITIES

Question 19

How does adulteration of misbranded coincide with the USP/NF?

Answer 19

If a drug is listed by it’s official name in USP/NF it must meet the requirements specified within it otherwise it’s designated: “no USP/NF”

If it doesn’t have this designation it’s either misbranded, adulterated, or both.

Question 20

Drugs@FDA Primary Use?

Answer 20

To find

• Labels of approved drug products
• Find generics of brands
• Find all drug products active ingredients
• Regulatory hx
• Consumer info published post ‘98
• Find therapeutic equivalent drugs.