Pharmacy Laws Flashcards
1906 Pure food and drug Act
-incorrectly labeled drugs no longer sold
-manufacturers must give correct info on label b4 drug is sold
1914 Harrison Narcotic Act
-Enacted to curb rec. opium
-Rx only
-records required for Rx
-Imports and distrib. restric.
1938 Food, Drug, and Cosmetic Act
-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
1951 Durham Humphrey amendment
- 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
1962 Kefauver Harris Amendment
-ensures the safety and effectiveness of new drugs
-Manufactures made to ensure GMP
-stopped thalidomide sales in US
1970 comprehensive Drug Abuse Prevention and control act
-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
1970 poison prevention packaging act
-Childproofing
-both OTC and legend drugs
-no childproofing for: Dr request, some legend meds, emergencies, Pt or Dr request, Hospitalized Pt.
1970 occupational safety and health act
OSHA
1972 Drug listing act: NDC
-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.
1983 orphan Drug act
eased restrictions (and costs) for development of new drugs for those w/ a rare disease (affecting 1 in 200,000 ppl)
1984 Drug Price competition and patent-term restoration act (Hatch-waxman Amendment)
-Drug price competition and patent term restoration
-manufacturing and regulating generics
1987 prescribing drug marketing act
-helps prevent counterfeit drugs and ingredients from entering supply chain.
-Limits diversion of pharmaceutical samples and prescription drugs.
1990 Anabolic Steriod control act (updated on 2004)
-est. penalties for PTs to persuade ppl to use steroids
-makes steroids schedule 2
1990 omnibus budget reconciliation act (OBRA)
-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
1994 Dietary supplement health and education act (DSHEA)
Adds dietary supplements to the FDA&C act
1996 health insurance portability and accountability act (HIPAA)
-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.
2000 Drug addiction treatment ac
-pharms can prescribe controlled subs. to someone w/ opioid addiction
- only for maintenance or detox
-1st letter of DEA # is X
2003 medicare prescription drug improvement modernization act
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.
2005 combat methamphetamine epidemic act
restricts sale of OTC drugs used in the manufacturer of amphetamines
- addresses all areas of the manufacture and sale of pseudoephedrine.
2009 biologics pride competition and innovation (BPCI) act
- amends the FD&C act
-adds apps for biosimilar/ interchangeable biological products
2021 Affordable Car Act (ACA)
-pt. protection and ACA: electronic health records and medication therapy method
2013 Drug Quality and Security act (DQSA)
FDA tracking system for bulk compounding
Legend drugs
Prescription only
OTC
Over The Counter - no Dr’s order required
GMP
Good manufacturing practice
Thalidomide
Drug banned in the US in 1962 after causing birth defects in European kids
DEA
Drug enforcement administration
enforce laws covering controlled substances
DUR
-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
1951 Durham-Humphrey amendment
Required label on legend drugs, Dr order and supervision for CS, est. OTC and legend
1963 Kefauver-Harris amendment
Safety and effectiveness of new drugs, GMP, prevent sale of thalidomide in us
1970 comprehensive drug prevention and control act
EST. DEA, created schedules, DEA license # for CS, Allows pharmacists to order CS
1972 Drug listing act: national drug code
NDC, first is labeler, then product, then package
OBRA 1990
Omnibus budget reconciliation act, reimbursement regs for Medicare/ Medicaid, counsel pts but of can refuse, fixed HC Problems for old ppl
