Pharmacy Law Lecture 1 & 2

Purpose of pharmacy law

Protects public health and ensures accountability and professional standards in pharmacy practice.

Difference between law and regulation

Law is created by the legislature; regulation provides detailed implementation by administrative agencies.

Difference between ethics and morality

Ethics are professional standards; morality reflects personal beliefs about right and wrong.

Primary function of the California Board of Pharmacy

Regulates the practice of pharmacy, licenses personnel, and enforces pharmacy law.

Composition of the California Board of Pharmacy

Made up of licensed pharmacists and public members appointed by the governor.

Authority of the California Board of Pharmacy

Enforces California Business & Professions Code and pharmacy regulations to protect consumers.

Definition of pharmacist

A licensed health professional who prepares, compounds, dispenses, and provides information about drugs.

Definition of intern pharmacist

A person gaining supervised practical experience before becoming licensed.

Definition of pharmacy technician

An individual who assists a pharmacist in dispensing but cannot counsel or verify prescriptions.

Definition of pharmacy

A licensed facility where prescription drugs are stored, compounded, and dispensed.

Role of the pharmacist-in-charge (PIC)

Responsible for legal compliance and overall operation of the pharmacy.

Pharmacist responsibilities under law

Ensure safe dispensing, counsel patients, supervise staff, maintain records, prevent diversion.

Federal vs. state pharmacy law

Pharmacists must follow the stricter rule when federal and state laws differ.

Federal law examples

FDA and DEA regulations set national minimum standards for drug safety and control.

State law examples

California Business & Professions Code, Title 16 CCR sections on pharmacy practice.

Core ethical principles in pharmacy

Autonomy, beneficence, nonmaleficence, justice, fidelity.

Goal of professional ethics in pharmacy

Guide pharmacists in making morally sound and patient-centered decisions.

Example of legal vs. ethical conflict

It may be legal to deny service, but unethical if it harms patient care.

Purpose of pharmacy regulations

Provide specific rules for implementing laws and ensuring compliance.

Role of law in pharmacy practice

Defines the legal boundaries of pharmacist duties and protects public safety.

Controlled substance definition

Drugs regulated under the Controlled Substances Act due to abuse potential and dependence risk.

Schedule I characteristics

No accepted medical use, high abuse potential; examples: heroin, LSD, ecstasy.

Schedule II characteristics

Accepted medical use, high abuse potential; examples: oxycodone, morphine, Ritalin.

Schedule III characteristics

Moderate abuse potential; examples: Tylenol with codeine, anabolic steroids.

Schedule IV characteristics

Low abuse potential; examples: alprazolam, diazepam.

Schedule V characteristics

Lowest abuse potential; examples: cough syrups with codeine.

DEA primary role

Enforces the Controlled Substances Act and oversees registration, ordering, and reporting.

California DOJ/BOP role

Enforce Health & Safety Code and Business & Professions Code for state-level control.

CURES program purpose

Tracks Schedule II–V prescriptions to prevent diversion and abuse.

CURES who reports

Pharmacies, hospitals, and dispensing physicians.

CURES reporting deadline

Within 1 business day of dispensing.

CURES check requirement

Prescribers must check patient’s CURES report before prescribing Schedule II–IV drugs.

Controlled substance recordkeeping duration

At least 3 years per California law.

DEA Form 222 purpose

Required for ordering Schedule II controlled substances.

CSOS purpose

Electronic ordering system for Schedule II controlled substances.

Power of attorney in DEA context

Authorizes staff to sign DEA 222 forms on behalf of registrant.

Loss or theft reporting to DEA

DEA Form 106 must be filed within 1 business day.

Loss or theft reporting to BOP

Report within 30 days; within 14 days if due to theft or self-use.

Controlled substance inventory frequency

Initial and biennial inventories required by DEA; quarterly for C-II in California.

Who can prescribe controlled substances

MD, DO, dentist, veterinarian, NP, PA, CNM, naturopathic doctor, advanced pharmacist.

Controlled substance prescription validity

Valid for 6 months from date written; no refills for Schedule II.

Controlled substance prescription form

California Security Prescription Form with 15 anti-fraud features.

Electronic prescribing requirement

Prescribers must be capable of issuing e-prescriptions under B&P §688.

EPCS meaning

Electronic Prescribing for Controlled Substances; DEA-compliant system with two-factor authentication.

Generic substitution rule

Allowed unless prescriber writes “Do not substitute.”

Form variation rule

Pharmacist may change dosage form to improve adherence if equivalent.

Expedited Partner Therapy (EPT) definition

Treating sexual partners of STI patients without prior exam; authorized by law.

PIC recordkeeping duty

Ensure all required pharmacy and controlled substance records are maintained for inspection.

Inventory reconciliation requirement

Quarterly for C-II, annually for specified C-IV–V drugs like alprazolam and tramadol.

DEA registration for pharmacist prescribers

Required for advanced practice pharmacists adjusting controlled substance therapy.

Controlled substance prescription expiration

6 months from issue date; C-II cannot be refilled.