Pharmacist Practice — Federal Law

A drug is prescription-only if, because of its toxicity, potential for harm, method of use, or the collateral measures needed to use it, it is not safe except under a licensed practitioner's supervision, or if its approved application limits it to prescription use.

The Durham-Humphrey Amendment of 1951 created the two classes of prescription and OTC drugs. It also authorized oral prescriptions and refills for prescription drugs.

The label must bear at least the symbol "Rx only." The Food and Drug Administration Modernization Act of 1997 replaced the older "Caution: Federal law prohibits dispensing without prescription" legend with this shorter statement.

Dispensing a prescription drug without a valid prescription is treated as an act that causes the drug to be misbranded while held for sale (FD&C Act 503(b)(1)). The pharmacy and pharmacist can face FDA enforcement for misbranding.

Yes. FD&C Act 503(b)(1) allows prescription drugs to be dispensed on an oral prescription that the pharmacist promptly reduces to writing. States may add conditions, such as who may transmit it.

Refills may be authorized by the prescriber either in the original prescription or by an oral or written authorization. The FD&C Act sets no federal cap on the number of refills or on how long a non-controlled prescription stays valid; those limits come from state law.