1. 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
Active ingredients listed, no mislableing(misleadiung). due to deplorable meat processing, ‘rat by-products’ misbranding and adulterated. death by contamination
in must provide scientific evidence for claims
Harrison Narcotic act of too much opium used. all narcotics must have ‘tax stamp’ or be seized.
Federal Food Drug and Cosmetic act of 1938(FFDCA)(FDC)--replaced federal food and drug act. Due to antifreeze in elixir. Must file for NDA for approval to market(to be a drug). tougher on adulteration and misbranding. drugs must be demonstrated safe to be allowed to market. ‘may be habit forming’.
Also must be therapeutic.

2. pharm laws some amendments to FFDCA
Durham-Humphrey amendment of instructions must be on the label. Drugs are now legend(prescription) or OTC. ‘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 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 barbituate and stimulants included in Harrison. tax stamps replaced with Congress regulations.
drug listing act of any drug business(prepare, process, manufacture, compound, package) must register with FDA. drug names, dosage, route of administration,NDC#.

3. pharm laws
PPPA--poison prevention packaging act of 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, nursing home)
CSA(controlled substances act) of 1970=
Comprehensive drug abuse prevention&control act
Created DEA
creates 5 schedules(C2 rx needs #30 and thirty on rx)
Drug listing act of made list of all rx meds and gave their NDC number
medical device amendment of some medical devices must get pre-market approval

4. pharm laws
Orphan drug act of 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 no more re-importing. 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.

5. pharm laws
OBRA(omnibus budget reconciliation act)of 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 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 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.

6. pharm laws
FDA modernization act of 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
Established medicare part D(purchasing rx drugs in medicare)
Combat methamphetamine epidemic act of ephedrine and pseudoephedrine must be behind the counter and record name of buyer. Max 3.6g per day and 9g per month

7. pharm laws
Comprehensive Drug Abuse Prevention and Control Act of (CSA)controlled substance act. replaced Harrison act and DACA. depends on record keeping drug transactions. created DEA number.
Anabolic steroid control act of 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(drug,buyer,date) limits amount per purchase per month.

8. pharm laws
Ryan Haight online pharmacy consumer protection act of amendment to CSA. DEA can take action against unapproved internet pharmacies.
Medicaid Tamper-resistant prescription act of any prescription for Medicaid must be on tamper resistant blank.
Bureau of narcotics and dangerous drugs is named DEA
OSHA of increase job safety, report injuries and violations. MSDS must be given to pharmacy when buying dangerous chemicals.
Drug addiction act of 2000—sch3-5 can be used instead of methadone for opioid addicts. Pt must be in recovery program. Dr must have DEA training.

9. 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 or DPharm will report any
medication that looks weird or adverse reaction.
report to fda.gov/medwatch

10. 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
Case law=common law=judicial court system
Statutory Law=written laws(acts)usually enacted by a legislative
body
Assumption of risk=pt didn’t listen…AMA
Subpoena—you must appear in court as witness or deposition.
Slander---false talking
Libel—false writing/advertising
Ethics—moral values for a profession
Law video---