Prescription Requirements, Dispensing, Labeling, and Recordkeeping
What makes a prescription valid
A prescription must identify the patient, the drug (name, strength, dosage form), quantity, directions for use, the prescriber (name, address, and DEA number for controlled substances), the date, refills authorized, and the prescriber's signature or valid electronic signature. The prescriber must be acting within scope and, for controlled substances, properly registered.
Filling, refills, and substitution
- Oral prescriptions must be reduced promptly to a written or electronic record.
- Refills may not exceed what the prescriber authorized or what the drug's schedule allows.
- Maryland permits substitution of a therapeutically equivalent generic unless the prescriber indicates otherwise or the patient objects; the pharmacist notifies the patient (and the prescriber where required) and records the substitution.
- Transfers between pharmacies follow federal and Board rules, with documentation by both the transferring and receiving pharmacist.
Labeling
An outpatient label shows the pharmacy name and address, prescription number, date, patient name, directions, prescriber, drug name/strength/quantity, beyond-use or expiration date, refills, and required cautions including the federal controlled-substance warning. Auxiliary labels address storage and administration risks.
Counseling
A pharmacist, or an intern under supervision, must offer to counsel on new prescriptions and on refills when warranted, covering directions, common adverse effects, interactions, storage, and missed doses. A refusal should be documented; counseling cannot be delegated to a technician.
Worked example
A patient presents a paper prescription for amoxicillin 500 mg with no dispensing restriction noted. The pharmacist may substitute an equivalent generic, must record the substitution and notify the patient, must label with the full required data set, and must offer counseling, documenting a refusal if declined.
Traps
Assuming a technician may counsel; believing a pharmacist can cure a prescription missing required elements; confusing a beyond-use date with the manufacturer's expiration date.