Nonprescription Medication Program

Nonprescription Medication Program - index
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Ref:

(a) COMDTINST 6570.4, Pharmacy Procurement and Dispensing Guidelines

PURPOSE. This instruction establishes policy and procedures for those Coast Guard units

choosing to provide a non- prescription medication program to their beneficiaries. This

directive applies to all units with health services personnel assigned.

BACKGROUND.

Recent trends show people are taking an increasingly active role in their health care. The

average American faces a self-treatable problem every three days, usually for conditions

such as colds, headaches, or mild skin irritations. Treating these conditions without costly

physician visits has been a constant challenge to the health care system. In response, since

1976 more than 200 drug products, formerly classified as "prescription only", have been

made available to the public without a prescription.

The 1951 Humphrey-Durham amendments to the 1938 Federal Food, Drug, and Cosmetic

Act clarified the responsibility of the Food and Drug Administration (FDA) to establish

criteria for assigning prescription or nonprescription drug status to products. To attain

nonprescription drug status, the FDA must establish that a product is nonaddictive, is safe

for use without the supervision of a licensed practitioner, and has directions and warnings

which are given in terms likely to be read and understood by an ordinary individual,

including an individual of low comprehension, under the customary conditions of

purchase and use. Products, when classified as nonprescription, may be marketed and

distributed by any commercial source. Retail pricing is often 3-4 times the Federal supply

acquisition cost for these items and places a financial strain on Coast Guard beneficiaries.

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