Federal Drug Laws

Question 1

HTS and UHTS (drug development)

Answer 1

High Throughput and Ultra High Throughput Screening

Question 2

DART

Answer 2

Developmental and Reproductive Toxicity

Question 3

NOEL

Answer 3

No Observed Effect Level (maximum level at which a toxic effect is not seen)

Question 4

IND

Answer 4

Investigational New Drug application (submited to FDA to get permission for clinical trials)

Question 5

Federal Food Drug and Cosmetic Act (FDCA, 1938)

Answer 5

Setup the FDA

Question 6

Constrolled Substances Act (CSA, 1970)

Answer 6

Set laws regarding drugs of abuse and controlled substances. Overseen by the DEA, which was created three years later (1973)

Question 7

Federal Food and Drug Act of 1906

Answer 7

Prohibited adultered and misbranded foods and drugs from interstate commerce

Question 8

Federal Narcotic Drug Act of 1914 (Harrison Narcotic Act)

Answer 8

Made it illegal to sell or possess narcotics execpt in a tax stamped package

Question 9

Durham-Humphrey Amendment of 1951 (Prescription Drug Amendment)

Answer 9

Created the notion of prescription drugs

Question 10

Legend Drugs

Answer 10

Drugs that are required to have a label stating that they require a prescription

Question 11

Kefauver-Harris Amendment (Drug Efficacy Amendment of 1962)

Answer 11

Manufactures must prove efficacy and safety of drugs, FDA would control prescription drug advertising and applications, mandated informed consent and AE reporting

Question 12

Orphan Drug Act of 1983

Answer 12

Incetivized development of drugs for less profitable conditions

Question 13

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act or Generic Drug Act)

Answer 13

Accelerated approval of generic versions, required demonstration of bioequivalence

Question 14

Prescription Drug Marketing Act of 1987

Answer 14

Prevented retail sale of substandard/counterfit drugs, samples, re-imported drugs

Question 15

Anabolic Steroids Control Act and Omnibus Budget Reconciliation Act of 1990 (OBRA)

Answer 15

Controlled anabolic steroids, made amendments to medicare/medicaid, denied reimbursement for unsafe/ineffective drugs, off-label prescribing

Question 16

Prescription Drug User Fee Act of 1992 (PDUFA)

Answer 16

Made manufacturers pay user fees for new drug applications, resulted in decreased review time by FDA

Question 17

FDA Modernization Act of 1997 (FDAMA)

Answer 17

Focused the FDA on including women and minorities more in clinical trials

Question 18

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Answer 18

Extended medicare to include prescription drugs

Question 19

Combat Methamphetamine Epidemic Act of 2005

Answer 19

Regulates selling of ephedrine, pseudoephedrine and phenylpropanolamine (precursors to meth)

Question 20

Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Answer 20

Made law the concept of biosimilar for biologics drugs

Question 21

Schedule 1 Drug

Answer 21

High abuse potential, no accepted medical use

Question 22

Schedule 2 Drug

Answer 22

High abuse potential, current accepted medical use. Abuse may lead to dependence

Question 23

Schedule 3 Drug

Answer 23

Some abuse potential, accepted medical use. Moderate or low potential for physical dependence and high potential for psychological dependence

Question 24

Schedule 4 Drug

Answer 24

Accepted medical use, limited potential for dependence (Rx required)

Question 25

Schedule 5 Drug

Answer 25

Accepted medical use, limited dependence possible (no Rx but sign log book)

Question 26

What added steps are necessary for prescription of a controlled substance that are not necessary for prescription of a legend drug (regular prescription drug)?

Answer 26

1) DEA number of prescriber on prescription, 2) Prescription cannot be pre- or post-dated, 3) Label must have particular caution statement on it

Question 27

FDA’s Orange Book

Answer 27

A publication of bioequivalent products (full name is Approved Drug Products with Therapeutic Equivalence Evaluations)

Question 28

Bioequivalence

Answer 28

Equivalent release of the same drug substance

Question 29

What is the difference between generic substitution and therapeutic substitution?

Answer 29

Therapeutic substitution involves swapping for a chemically different drug, whereas generic substitution involves swapping for a different product which is chemically the same drug (bioequivalent)

Question 30

How do conflicting drug laws get resolved?

Answer 30

The more stringent law prevails (except in military or VA where federal law prevails)