Pharmacy Laws

ExCPT

Controlled Substances Act (CSA) of 1970

Created the Drug Enforcement Administration (DEA)

Drugs classified into Schedules l-V

• l: high abuse, no medical use

• ll: high abuse, accepted medical use

• lll-V: less abuse risk, accepted medical uses

DEA

DEA registration is needed for handling controlled substances

DEA Form 222

Used for ordering C2s

DEA Form 41

Used for the destruction of controls

DEA Form 106

Used to report theft or loss

Food, Drug, and Cosmetic Act (FDCA) of 1938

• Required drugs to be safe and properly labeled

• Gave FDA authority to look over drug safety

• Prohibits the sale of adulterated or misbranded drugs

Drug Enforcement Administration (DEA)

• Enforces controlled substance laws

• Assigns DEA numbers to practitioners

HIPAA (Health Insurance Portability and Accountability Act)

• Protects patient privacy and health info

• Pharmacy Techs must maintain confidentiality

• Has rules about PHI (Protected Health Info)

OBRA ‘90 (Omnibus Budget Reconciliation Act of 1990)

• Requires Pharmacists to offer counseling to Medicaid patients

• Emphasizes DUR (Drug Utilization Review) for safety

Combat Methamphetamine Epidemic Act of 2005

• Regulates sales of pseudoephedrine, ephedrine, and phenylpropanolamine

• Must be behind the counter

• Requires ID, sales limit, and logbook records

Poison Prevention Packaging Act (PPPA)

• Requires most drugs to be in child resistant packaging

• Exceptions include nitroglycerin, birth control packs