Pharmacy Laws

Question 1

1906 Pure food and drug Act

Answer 1

-incorrectly labeled drugs no longer sold
-manufacturers must give correct info on label b4 drug is sold

Question 2

1914 Harrison Narcotic Act

Answer 2

-Enacted to curb rec. opium
-Rx only
-records required for Rx
-Imports and distrib. restric.

Question 3

1938 Food, Drug, and Cosmetic Act

Answer 3

-1906 law not strict enough and didn’t have cosmetics
-Include direcs.
-addictive substances labeled “Warning: may be habit forming”
-misbranding and adulteration illegal
-food labels, identity, imitation food info, nut. for spc. dietary food
-legal status of the FDA

Question 4

1951 Durham Humphrey amendment

Answer 4

• rqur. labels on RX drugs “caution:federal law prohibits dispensing w/o a Rx”
  -Dr’s order & supervision for some drugs
• made distinction btwn legend and OTC

Question 5

1962 Kefauver Harris Amendment

Answer 5

-ensures the safety and effectiveness of new drugs
-Manufactures made to ensure GMP
-stopped thalidomide sales in US

Question 6

1970 comprehensive Drug Abuse Prevention and control act

Answer 6

-Created DEA
-created 1-5 schedules for controlled substances
-`Dea license # for physicians so can Rx controlled substances
-licenses for pharmacies : allows them to order contr. substances

Question 7

1970 poison prevention packaging act

Answer 7

-Childproofing
-both OTC and legend drugs
-no childproofing for: Dr request, some legend meds, emergencies, Pt or Dr request, Hospitalized Pt.

Question 8

1970 occupational safety and health act

Answer 8

OSHA

Question 9

1972 Drug listing act: NDC

Answer 9

-10 digit number, unique to label, product and package size/type
-part 1: labeler code
-part 2: Product code
-Part 3: package code
NDC will be in the 4-4-2,5-3-2, or 5-4-1 config.

Question 10

1983 orphan Drug act

Answer 10

eased restrictions (and costs) for development of new drugs for those w/ a rare disease (affecting 1 in 200,000 ppl)

Question 11

1984 Drug Price competition and patent-term restoration act (Hatch-waxman Amendment)

Answer 11

-Drug price competition and patent term restoration
-manufacturing and regulating generics

Question 12

1987 prescribing drug marketing act

Answer 12

-helps prevent counterfeit drugs and ingredients from entering supply chain.
-Limits diversion of pharmaceutical samples and prescription drugs.

Question 13

1990 Anabolic Steriod control act (updated on 2004)

Answer 13

-est. penalties for PTs to persuade ppl to use steroids
-makes steroids schedule 2

Question 14

1990 omnibus budget reconciliation act (OBRA)

Answer 14

-practicing pharm.
-enacted bcs of reimbursement regs. for medicare and medicaid
-Pharms counsel the pt. at purchase (pharm tech can’t)
-DUR estb.
- evaluates drug therapy, review drug therapy, DUE board review

Question 15

1994 Dietary supplement health and education act (DSHEA)

Answer 15

Adds dietary supplements to the FDA&C act

Question 16

1996 health insurance portability and accountability act (HIPAA)

Answer 16

-deal w/pt.’s rights to continuance of HI
-family member is not a HIPPA covered entity
- limits type of info that can be released
-for pharm: pharmacists and techs have direct knowledge of a pt.’s Med info, pt. must sign form for others to view.

Question 17

2000 Drug addiction treatment ac

Answer 17

-pharms can prescribe controlled subs. to someone w/ opioid addiction
- only for maintenance or detox
-1st letter of DEA # is X

Question 18

2003 medicare prescription drug improvement modernization act

Answer 18

Govt. insurance for seniors and for those w/ long-term disabilities under the age of 65
-june 1, 2004 - medicare pays for some drugs through discount cards
- medicare pays for some med. devices like walkers, breathing mach, diabetic supplies and bedside commodes.

Question 19

2005 combat methamphetamine epidemic act

Answer 19

restricts sale of OTC drugs used in the manufacturer of amphetamines
- addresses all areas of the manufacture and sale of pseudoephedrine.

Question 20

2009 biologics pride competition and innovation (BPCI) act

Answer 20

• amends the FD&C act
  -adds apps for biosimilar/ interchangeable biological products

Question 21

2021 Affordable Car Act (ACA)

Answer 21

-pt. protection and ACA: electronic health records and medication therapy method

Question 22

2013 Drug Quality and Security act (DQSA)

Answer 22

FDA tracking system for bulk compounding

Question 23

Legend drugs

Answer 23

Prescription only

Question 24

OTC

Answer 24

Over The Counter - no Dr’s order required

Question 25

GMP

Answer 25

Good manufacturing practice

Question 26

Thalidomide

Answer 26

Drug banned in the US in 1962 after causing birth defects in European kids

Question 27

DEA

Answer 27

Drug enforcement administration
enforce laws covering controlled substances

Question 28

DUR

Answer 28

-drug utilization evaluation or drug utilization review
-HCW must review the whole process for appropriateness
-review of possible drug interactions, dosage and duration and contraindications

Question 29

1951 Durham-Humphrey amendment

Answer 29

Required label on legend drugs, Dr order and supervision for CS, est. OTC and legend

Question 30

1963 Kefauver-Harris amendment

Answer 30

Safety and effectiveness of new drugs, GMP, prevent sale of thalidomide in us

Question 31

1970 comprehensive drug prevention and control act

Answer 31

EST. DEA, created schedules, DEA license # for CS, Allows pharmacists to order CS

Question 32

1972 Drug listing act: national drug code

Answer 32

NDC, first is labeler, then product, then package

Question 33

OBRA 1990

Answer 33

Omnibus budget reconciliation act, reimbursement regs for Medicare/ Medicaid, counsel pts but of can refuse, fixed HC Problems for old ppl