FEDERAL REGULATIONSS

FDA

Regulates drug approval, safety, labeling, manufacturing

DEA

Enforces controlled substance laws

CSA

Controlled Substances Act

DOJ

Oversees DEA

FTC

Prevents false advertising

USP

Sets drug quality standards

FD&C Act

Created FDA and drug safety laws

Kefauver-Harris Amendment

Requires drug safety and efficacy

Durham-Humphrey Amendment

Prescription vs OTC classification

Orphan Drug Act

Encourages rare disease drug development

Schedule I

No accepted medical use, high abuse potential

Schedule II

High abuse potential, no refills

Schedule III

Moderate abuse potential, 5 refills/6 months

Schedule IV

Lower abuse potential, 5 refills/6 months

Schedule V

Lowest abuse potential, refills allowed

C-II RX

Written or electronic only

C-II refills

Not allowed

C-II expiration

No federal expiration (state may differ)

Emergency C-II

Oral allowed, limited supply, follow-up RX required in 7 days

C-III–V RX

Written, oral, or electronic

C-III–V expiration

6 months from issue date

C-III–V refills

Max 5 refills in 6 months

Partial fill C-II

Allowed if full quantity unavailable

C-II partial expiration

Remaining must be filled within 72 hours

DEA registration

Required to dispense controlled substances

DEA Form 222

Order Schedule II drugs

Power of Attorney

Allows tech/pharmacist to order C-II

Perpetual inventory

Required for C-II drugs

Controlled inventory

Every 2 years minimum

RX

Prescription

℞

Prescription symbol

NRX

New prescription

RF

Refill

Required RX info

Patient name, drug, strength, directions, prescriber, date

Label must include

Pharmacy name/address, RX number, patient name

OBRA-90

Requires pharmacist counseling (Medicaid)

Counseling includes

Drug name, directions, side effects, interactions

HIPAA

Protects patient health information

PHI

Protected Health Information

Minimum necessary

Only share needed info

PPPA

Requires child-resistant packaging

Non-safety cap

Allowed if patient or prescriber requests

Lot number

Identifies drug batch

Expiration date

Last date drug is safe/effective

Orange Book

FDA approved drugs & equivalence

AB rating

Therapeutically equivalent generic

Therapeutic equivalence

Same safety & efficacy

REMS

FDA risk management program

MedWatch

FDA adverse event reporting

Anabolic Steroid Control Act

Classifies steroids as C-III

Combat Methamphetamine Epidemic Act

Regulates pseudoephedrine

Pseudoephedrine daily limit

3.6 grams/day

Pseudoephedrine monthly limit

9 grams/month

ID required

For pseudoephedrine purchase

Pharmacy technician

Cannot counsel patients

Tech verification

Final check must be pharmacist

Tech duties

Data entry, counting, labeling

Refrigerated drugs

36–46°F (2–8°C)

Room temperature

68–77°F (20–25°C)

Diversion

Illegal transfer of drugs

Theft/loss

Must be reported to DEA