Prescribing, Dispensing, Compounding, and Drug Distribution
Valid prescriptions and dispensing
A prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Screen every prescription for prescriber authority, patient identity, drug and dose, quantity, directions, date, and authenticity. Faxed Schedule II prescriptions are limited to narrow exceptions. Counseling must be offered on new and changed prescriptions, with refusals documented.
Substitution and labeling
Generic substitution is a state-law function: the product must be therapeutically equivalent, the prescriber must not have prohibited substitution, and the patient must be informed, with the substitution recorded. The dispensing label must show pharmacy name and address, prescription number, date, patient name, directions, prescriber, drug name and strength, quantity, and required cautions.
Transfers and distribution
Transfers of prescription information between pharmacies are limited - federal rules sharply restrict Schedule II transfers, and state rules govern the rest. Wholesale distribution requires licensure and tracing documentation.
Compounding
503A compounding is patient-specific, on a prescription from a licensed prescriber, using bulk ingredients from registered sources, and must follow USP <795> (nonsterile), <797> (sterile), and <800> (hazardous drugs). 503B outsourcing facilities compound without patient-specific prescriptions, register with FDA, and follow cGMP. Compounding an essentially a copy of a marketed drug is generally not permitted.
Traps
- Assuming any pharmacy may ship compounded sterile products interstate without additional licensure.
- Skipping verification of the prescriber's DEA or state authority before dispensing a controlled substance.
- Treating a transfer or correction as routine for Schedule II.
Rule of thumb: every dispensing question asks three things - is the prescriber authorized, is the prescription complete and authentic, and does the product and label comply?