591 Law & Ethics Midterm #1

CABOP

california state board of pharmacy (state level, licensing, reg, enforce, discipline)

DEA

federal controlled subs, registration, diversion, scheduling, records, distribution, enforce

FDA

regulated products ( drug/biologic safety and efficacy, approval, labeling, manufacturing quality, devices, food, cosmetic, dietary supp)

statutory law

BINDING: legislature created

admin regulations

BINDING: agency created under authority

guidance

generally NON-BINDING: recommended compliance/best practice approach, inform standard of care

professional standards

expected level of care/skill

code of ethics

advisory unless adopted into law/reg; professional values

case law

BINDING: court decisions interpreting legal duties, within applicable jurisdiction

accreditation

generally voluntary, but operationally powerful; private quality/safety evaluation

employer policy

mandatory within org, not a statue; org-specific required process

administer

directly apply a drug/device to patients body

furnish

supply a drug/device by any means, by sale or otherwise

dispence

furnish pursuant to a prescription or qualifying order/direct practitioner authority

how many interns per one pharmacist?

2 interns simultaneously

how many technicians per one pharmacist?

3 techs

misbranding

labeling/presentation problem

adulteration

product/manufacturing/quality problem

pure food & drug act (1906)

early consumer protection, adulteration/misbranding and dangerous ingredient disclosure

food drug & cosmetic act (1938)

strengthened safety/labeling authority, broader FDA enforcement

Durham-Humphrey

modern prescription vs OTC distinction

Kefauver-Harris (1962)

proof of effectiveness to safety

Drug Listing Act (NDA) 1972

NDC identifies labeler, product, package size

orphan drug act

rare disease develpment incentives

Hatch-Waxman

ANDA pathway for generics; equivalence/bioequivalence rather than repeating full clinical program

DSHEA (Dietary Supplement Health and Education Act)

federal framework for dietary supplements; regulated more like foods than drugs

21st century cures

accelerated innovative product development; real-world evidence and patient perspectives

PPPA (poison protection packaging act)

child-resistant packaging to reduce poisoning

CSA

controlled substance scheduling; DEA registration oversight

CMEA (Combat Methamphetamine Epidemic Act)

controls pseudoehedrine/ephedrine/PPA sales; 3.6g/day, 9g/30 days

IND

Investigational New Drug: submitted before clinical research in humans

NDA

New Drug Application: full new-drug approval after Phase 3

- BLA: biologic licensing application

- ANDA: abbreviated generic pathway relying on the reference product

REMS (Risk Evaluation and Mitigation Strategies)

FDA required drug safety program, added safety controls

faxing vs. oral prescription

fax: clerks/technicians

new oral: received/reduced ONLY by pharmacist or intern pharmacist

four items for PCC labeling

patient name —> drug name & strength —> directions —> condition/purpose when on prescription

refills

schedule 2: cannot be refilled

schedule 3-5: max 5 refills within 6 months, total refills not exceed 120-day supply