This chapter provides guidance in the use and application of unit-of-use packaging and is intended for use by drug manufacturers, repackagers, and pharmacists. Suppliers of packages and packaging components may find the information useful, as well.
The General Notices defines a unit-of-use container as one that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling.
Unit-of-use packaging, when provided by the manufacturer, offers some of the following attractive advantages. (1) A dosage form can be dispensed to a patient in the manufacturer's original container, a practice that recognizes that the suitability of the container has been established on the basis of the manufacturer's stability studies. (2) The counting and repackaging of dosage units in the pharmacy is eliminated, thereby reducing the possibility of human error. (3) The pharmacist is able to affix the label for the patient onto the unit-of-use package and is free to use the manufacturer's expiration date as the beyond-use date. (4) The number of dosage units in a single unit-of-use package may be determined on a case-by-case basis. (5) Patient compliance is improved. (6) The unit-of use package can protect against countertfeiting because traceability of product is ensured through bar coding techniques and NDC numbers.
Unit-of-use packaging, when provided by repackagers, offers the same attractive advantages as those offered by the manufacturer. However, unit-of-use repackagers should conform to all requirements as presented in Good Repackaging Practices 1178
. There are a number of reasons why repackagers produce unit-of-use packaging: for example, (1) requests from institutions, (2) better inventory control, (3) reduced dispensing times, and (4) variations in some drug therapies.
The packaging of a unit-of-use system may be a multiple container or a single-unit container. A unit-of-use system may contain a drug product in a liquid, semisolid, or solid dosage form (see also FDA Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics). [NOTEThe terms unit-of-use package and unit-of-use container may be used interchangeably.]
The Poison Prevention Packaging Act (PPPA) of 1970 requires in certain cases the use of special packagingchild-resistant and senior-friendly. Child-resistant packaging protects children from serious injury or illness resulting from ingesting or handling hazardous products including drugs.
Because drugs packaged in unit-of-use packaging are intended to be dispensed to the consumer without repackaging by the pharmacist, the manufacturer or repackager is responsible for the special packaging of PPPA-regulated substances in unit-of-use containers (l6 CFR 1701.1).
INFORMATION FROM MANUFACTURERS
The manufacturer should provide appropriate stability information that can be used to determine appropriate labeling, storage, and shipping statements that will properly inform patients and practitioners. The manufacturer may make other assurances based on product information on packaging and distribution arrangements. In the event that a product is not to be repackaged, the manufacturer may so state in the labeling. The manufacturer also includes labeling and information suitable for optimal handling by the practitioner and the patient. The labeling and information should be bar coded to eliminate medication error and promote medication traceability.