View source for USLegal:Prescription only

'''Prescription only''' is the [[United States]] legal status of a medicine that may lawfully be dispensed only on the authorization of a licensed prescriber. It is the default status for any medicine that is not safe for use without professional supervision, and it is the status carried by most of the medicines in this reference.

A clear statutory line between medicines the public may select for itself and medicines that require a prescriber did not exist until the middle of the twentieth century. The [[Federal Food, Drug, and Cosmetic Act]] of 1938 required that a medicine bear adequate directions for use, but it largely left manufacturers to decide which products were too dangerous for self-selection, and practice was inconsistent. The '''Durham-Humphrey Amendment''' of 1951, sponsored by Representative Carl Durham of North Carolina and Senator [[Hubert Humphrey]] of Minnesota, a pharmacist by training, amended the 1938 Act to create the modern two-class system: a medicine is either available [[USLegal:Over-the-counter|over the counter]] or restricted to sale on a prescription.

== Statutory and regulatory basis ==
The controlling provision is section 503(b) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 353(b), added by the Durham-Humphrey Amendment.<ref name="dha">Durham-Humphrey Amendment of 1951, Pub. L. 82-215. Federal Food, Drug, and Cosmetic Act § 503(b), codified at 21 U.S.C. § 353(b).</ref> The [[Food and Drug Administration]] determines, in the course of approving a medicine, whether it may be sold over the counter or only on prescription. A prescription medicine is identified by the labeling statement "Rx only"; before the Food and Drug Administration Modernization Act of 1997, the required statement was the longer legend "Caution: Federal law prohibits dispensing without prescription."<ref name="fdama">Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, § 126.</ref>

A prescription medicine that is also a controlled substance carries, in addition to this status, a [[Drug Enforcement Administration]] schedule (Schedules [[USLegal:DEA Schedule II|II]] through [[USLegal:DEA Schedule V|V]]), which imposes further restrictions on prescribing, refilling, and recordkeeping.

== Criteria ==
Under 21 U.S.C. § 353(b), a medicine is restricted to prescription sale if, because of its toxicity or other potential for harmful effect, the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. A medicine that does not meet that test, and that can be labeled with directions allowing safe use by the public, is an [[USLegal:Over-the-counter|over-the-counter]] medicine. The Food and Drug Administration may move a medicine from prescription to over-the-counter status through the [[Rx-to-OTC switch]] process when accumulated evidence shows it can be used safely without professional supervision.

== In practice ==
A prescription medicine may be dispensed only on the order of a prescriber licensed by the state in which the patient is treated, and only by or under the supervision of a pharmacist. The prescription may be written, transmitted electronically, or, in most cases, given orally to the pharmacy. For prescription medicines that are not controlled substances, federal law sets no limit on the number of refills or the period over which they may be filled; the prescriber authorizes refills at their discretion, subject to state law. Prescription medicines that are also controlled substances are subject to the stricter refill and recordkeeping rules of their [[Drug Enforcement Administration]] schedule.

== Medicines in this status ==
The medicine pages that carry the prescription-only legal status are indexed here.

== References ==
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