pharm
laws
only federal laws on test----city and state laws also
FDA---est 1862
• Federal food and drug act of 1906(Wiley act)
The first federal law on drugs. demand purity of products
due to deplorable meat processing, ‘rat by-products’
misbranding and adulterated. death by contamination
in 1912 ---must provide scientific evidence for claims
• Harrison Narcotic act of 1914---too much opium used.
all narcotics must have ‘tax stamp’ or be seized.
•
•
Federal Food Drug and Cosmetic act of 1938(FFDCA)-replaced federal food and drug act. Due to antifreeze in
elixir. Must file for NDA for approval to market. tougher on
adulteration and misbranding. drugs must be demonstrated
safe to be allowed to market. ‘may be habit forming’.
Also must be therapeutic.
pharm laws
• some amendments to FFDCA
• Durham-Humphrey amendment of 1951--instructions must be on the label.
legend(prescription) drugs are created. ‘federal law prohibits dispensing
without a prescription’ (now --rx only). OTC drugs must have warning and
list all ingredients and amounts.
• Rx over phone allowed and refills from dr phone.
• Kefauver-Harris amendment of 1962--added proof of effectiveness and
safety before market. Drug advertising regulated by FDA. Required
package inserts on rx drugs. due to thalidomide birth defects.
• Drug Abuse Control Amendment(DACA) of 1965---barbituate and
stimulants included in Harrison. tax stamps replaced with Congress
regulations.
• drug listing act of 1972---any drug business(prepare, process,
manufacture, compound, package) must register with FDA. drug names,
dosage, route of administration,NDC#.
pharm laws
• PPPA--poison prevention packaging act of 1970-requires cap locks on all prescriptions except for
---pt asks for regular cap
---prescriber asks for regular cap
---some exempted drug(nitroglycerin,birth control,
bulky meds)
• CSA(controlled substances act) of 1970
Created DEA
creates 5 schedules
• Drug listing act of 1972---made list of all rx meds
and gave their NDC number
• medical device amendment of 1976---some medical
devices must get pre-market approval
pharm laws
• Orphan drug act of 1983---easier to create drug for
rare disease. Tax incentives and research grants and
7 year exclusivity. For less than 200,000 people
affected in US.
• Waxman-Hatch act of 1984(drug price competition
and patent term extension)---Ensured manufacturer
exclusivity and competitive generics after expiration.
• Prescription drug marketing act of 1987--no more reimporting. because expired drugs were shipped
outside of US then repacked with new date and
shipped back to US. or maybe counterfeit drugs.
company must monitor drug from manufacture to
pharmacy. this is called’pedigree’. also no more starter
samples to pharmacies.
pharm laws
• OBRA(omnibus budget reconciliation act)of 1990---congress tries to save money on Medicaid
prescriptions. Required RPh to offer counseling on
drugs.
• Anabolic steroid control act---put anabolic steroid in
sch 3.
• DSHEA(dietary supplement health and education
act)of 1994----forced standardized labeling and proof
of safety on vitamins, amino acids, herbs, minerals.
•
This product has not been evaluated by FDA. This product is not intended to diagnose treat cure or prevent
any disease
.
• HIPAA(health insurance portability and accountability act)of
1996----penalties for patient privacy violation. also created the
NPI number. national provider ID for insurance billing.
Pharmacies forced to put in policies to protect PHI.
pharm laws
• FDA modernization act of 1997---streamline drug
approval process, regulate compounding and
medical devices and mercury products. also gave us
‘Rx only’ on the bottle.
• Medicare Rx drug modernization act of 2003---Established medicare part D(purchasing rx drugs in
medicare)
• Combat methamphetamine epidemic act of 2005--ephedrine and pseudoephedrine must be behind the
counter and record name of buyer. Max 3.6g per
day and 9g per month
pharm laws
• Comprehensive Drug Abuse Prevention and Control
Act of 1970----(CSA)controlled substance act.
replaced Harrison act and DACA. depends on
record keeping drug transactions. created DEA
number.
• Anabolic steroid control act of 1990----anabolic
steroids are now schedule 3 drug due to misuse.
• CMEA(combat methamphetamine epidemic act of
2005)----controls SLCP drugs(scheduled listed
chemical products) that can be used to make
controlled drug.---must be stored in locked counter
at pharmacy,special training, verify purchaser, keep
log of purchase, keep record 2 years, limits amount
per purchase per month
pharm laws
• Ryan Haight online pharmacy consumer protection act
of 2008----amendment to CSA. DEA can take action
against unapproved internet pharmacies.
• Medicaid Tamper-resistant prescription act of 2008---any prescription for Medicaid must be on tamper
resistant blank.
• 1973---Bureau of narcotics and dangerous drugs is
named DEA
• OSHA of 1970----increase job safety, report injuries
and violations. MSDS must be given to pharmacy
when buying dangerous chemicals.
pharm laws
Patient Affordable Care Act of 2010(ACA) Obamacare
electronic health records
preexisting conditions not declined
medicare part D
2013 Drug Quality and Security Act-bulk compounding
2012 meningitis outbreak
compounding manuf register with FDA to sell to hosp
bar coding coming due to counterfeits
FDA reporting--pharm tech for DPharm was report any
medication that looks weird or adverse reaction.
report to fda.gov/medwatch
Pharmacy must keep original copy of rx for 3 years.
Syringes for sale??—must be over 18, maybe rx from dr
Pharmacy must not advertise syringes for sale.
Purchase will not exceed 10 syringes.
Criminal law---felony or misdeamor, fine or punishment
Civil law=tort. Fraud, libel, assault, slander,malpractice
Monetary punishment
Contract law---breach of contract punishment
Ethics—moral values for a profession
Law video---https://www.youtube.com/watch?v=DEfYnF8zhYA