Legal issues surrounding the number of dosage units dispensed

Pharmacists often are called to adjust the number of dosage units dispensed pursuant to a prescription. Common examples are requests to dispense half or double the amount requested by the prescriber. In some cases, reductions in quantity may be dictated by the provisions of a prescription drug insurance program, either private or governmental. A review of the literature reveals very little information on the legality of such actions by pharmacists. Focusing on both the federal Food, Drug and Cosmetic Act and the federal Controlled Substances Act, a review of the law in this area is presented. Some states also have provisions, either in statutes or regulations, that address the issue. Specific examples are presented and discussed, with the goal being to clarify the law in this area with which the pharmacist must deal on a daily basis.