(Pharm Law) M1 - FDA and DEA Acts

banned interstate selling of adulterated or mislabeled food/drugs

- requires prescriptions for narcotics (only)
- 1st time gov requires written prescription for any drug

- drugs must prove safety
- resulted bc anti-freeze found in meds (sulfanilamide) killed many kids

separated drugs into 2 classes: prescription and OTC

- drugs must be effective and safe
- resulted from thalidomide birth defects

- gave manufacturers financial incentives to create meds for rare diseases
- resulted bc HIV was discovered but no company cared enough to make treatment

- established modern system of generic drug regulation in the US
- goal was to encourage development of new meds and accelerate market entry of generics

- requires manufacturers to pay a fee for FDA approval applications
- money is used to fund drug approval process

- 1st time pharmacies are required to counsel pt’s
- fed can only require counseling for Medicaid pt’s
- state gov can opt in and require counseling for all pt’s

- guidelines to protect healthcare info from fraud and theft
- providers can’t disclose pt info to anyone other than pt and their authorized representatives without their consent

- installed a secure container for disposing controlled substances in pharmacies
- only for C2-C5 and non-controlled substances (no C1 or illegal drugs)

- established the Risk Evaluation and Mitigation Strategy (REMS)
- REMS = drug safety programs for meds with serious risks that require special monitoring

FDA can now regulate tobacco

- gave FDA more authority to regulate/monitor manufacturing of compounded drugs
- included DSCSA and CQA

- regulated delivery of drugs btwn manufacturing and dispensing location
- resulted bc packages sometimes get stuff added/stolen before reaching pharmacy

- FDA regulation of compounded drugs
- Resulted bc large compounder had unclean environ, caused fungal infection in lidocaine for spinal injection and lead to meningitis

medical devices are added to FDA regulation to be approved faster

drug companies are required to test their drug in diverse populations (not just young white men)

installed a secure container for disposing C2-5 and non-C substances in pharmacies

- Congress-mandated training requirements for DEA registered healthcare practitioners who prescribe controlled substances
- one-time 8 hrs training

- improved access by removing some barriers to buprinorphine and methadone treatment (for opioid use disorder)
- pt’s don’t need inpatient treatment beforehand, telehealth visits are allowed

- extra steps to reduce theft of ephedrine, pseudoephedrine, etc

- must be locked in cabinet behind counter
- must check buyer’s ID
- maintain log of each sale for 2 yrs
- limit quantities (does not apply to single sales packages less than 60mg pseudo sold within one day)