This chapter is intended to provide guidance to those engaged in pharmaceutical dispensing, not commercial repackaging. An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. Because the expiration date stated on the original manufacturer's container–closure system has been determined for the drug in that particular system and is not intended to be applicable to the product where it has been repackaged in a different container, repackaged drugs dispensed pursuant to a prescription are exempt from using the expiration date from the original manufacturer's package. However, under no circumstance should the repackaged pharmaceutical preparation's expiration date exceed the original manufacturer's expiration date. It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients.

The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.

In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication package (patient med pak).1

A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.

It is the responsibility of the dispenser to instruct the patient or caregiver on the use of the patient med pak.

the name of the patient;
a serial number for the patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;
the name, strength, physical description or identification, and total quantity of each drug product contained therein;
the directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;
any storage instructions or cautionary statements required by the official compendia;
the name of the prescriber of each drug product;
the date of preparation of the patient med pak and the beyond-use date or period of time assigned to the patient med pak (such beyond-use date or period of time shall be not longer than the shortest recommended beyond-use date for any dosage form included therein or not longer than 60 days from the date of preparation of the patient med pak and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein); alternatively, the package label shall state the date of the prescription(s) or the date of preparation of the patient med pak, provided the package is accompanied by a record indicating the start date and the beyond-use date;
the name, address, and telephone number of the dispenser (and the dispenser's registration number where necessary); and
any other information, statements, or warnings required for any of the drug products contained therein.

the name and address of the patient;
the serial number of the prescription order for each drug product contained therein;
the name of the manufacturer or labeler and lot number for each drug product contained therein;
information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;
the date of preparation of the patient med pak and the beyond-use date that was assigned;
any special labeling instructions; and
the name or initials of the pharmacist who prepared the patient med pak.