Study 3 Federal Pharmacy Law and Regulatory Requirements with 12 free online flashcards. Review key terms, definitions, and concepts with this interactive flashcard deck.
What does the FDCA require for prescription-only drugs?
The Federal Food, Drug, and Cosmetic Act requires prescription-only drugs to be dispensed under an authorized practitioner’s prescription and establishes baseline prescription and labeling rules.
What does the Controlled Substances Act regulate?
The Controlled Substances Act regulates controlled substances through scheduling, registration, prescription, dispensing, recordkeeping, and security requirements. The DEA administers it and its regulations.
What is the HIPAA Privacy Rule’s purpose in pharmacy practice?
The HIPAA Privacy Rule protects individually identifiable health information. Pharmacy staff should access and share it only as allowed for their work and follow reasonable safeguards and workplace procedures.
How do federal and state pharmacy requirements interact?
Federal law sets baseline requirements, while state law may add stricter rules, especially for pharmacy practice and technician duties. Follow applicable law and pharmacy policy.
What factors determine a controlled substance’s schedule?
The CSA classifies substances into Schedules I–V using factors including accepted medical use, abuse potential, and dependence risk. Schedules II–V have accepted medical uses and progressively lower relative abuse potential.
What makes a controlled-substance prescription legitimate under federal rules?
A controlled-substance prescription must serve a legitimate medical purpose and be issued by an authorized practitioner acting in the usual course of professional practice. The prescriber and dispensing pharmacist have corresponding responsibilities.
What information is generally required on a controlled-substance prescription?
Federal rules generally require the patient’s full name and address; prescriber’s name, address, and DEA registration number; drug name, strength, dosage form, quantity, and directions; and the date and required signature.
What should a technician do when a controlled-substance prescription raises a concern?
A technician who finds missing or conflicting information, or a possible safety or diversion concern, should pause processing and refer it to the pharmacist—not independently decide whether the prescription is valid.
How may a Schedule II prescription generally be transmitted?
Schedule II prescriptions are usually transmitted as manually signed paper prescriptions or compliant EPCS. A narrow emergency oral-prescription exception exists, and fax prescriptions are valid only in limited exceptions.
Which transmission methods are generally permitted for Schedules III–V?
Schedules III–V may generally be prescribed by signed paper prescription, compliant EPCS, permitted fax, or orally. The pharmacist must promptly reduce an oral prescription to writing with the required information.
Does DEA require every prescriber and pharmacy to use or accept EPCS?
DEA permits compliant electronic prescribing of controlled substances, but does not itself require every prescriber or pharmacy to use or accept EPCS. Other applicable rules may add requirements.
What is the federal refill rule for Schedule II prescriptions?
Federal law prohibits refills on Schedule II prescriptions. Separate prescriptions for up to a 90-day supply may be issued if federal conditions are met and state law permits.