Pharmacy Practice, Law, and Ethics
Jurisprudence and controlled substances
Pharmacy law is a layered system: federal statutes set a floor, and state boards of pharmacy may impose stricter rules. Know the Controlled Substances Act schedules. Schedule II drugs have high abuse potential and no refills; a partial fill is allowed if the pharmacist cannot supply the remainder within 72 hours, while patient- or prescriber-requested partial fills must be completed within 30 days under federal rules. Schedule III–V drugs have refill limits and expiration rules. Know DEA Form 222 for Schedule II ordering, PDMP use, REMS, and DSCSA tracking requirements. Prescription validity, required elements, transfer rules, and record retention are frequent test items.
Compounding and dispensing
Distinguish compounding from manufacturing. Pharmacists may not routinely compound copies of commercially available products. USP <795> covers nonsterile compounding, <797> sterile compounding, and <800> hazardous drugs. Beyond-use dates differ from manufacturer expiration dates. Dispensing requires accurate labeling, patient counseling, and error reporting.
Ethics and pharmaceutical care
Apply autonomy, beneficence, nonmaleficence, and justice. Address conflicts between patient welfare and business pressure, informed consent, privacy under HIPAA (minimum necessary), and duty to warn. Medication error reporting should be nonpunitive and systems-based.
Traps
Do not assume a Schedule II prescription is valid indefinitely; state rules vary. Do not use a manufacturer expiration date as a beyond-use date. Do not counsel by disclosing protected information without need.
Rule of thumb
When federal and state law conflict, follow the stricter requirement; when ethics conflict, prioritize patient safety and informed choice.