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 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.[1] 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."[2]
A prescription medicine that is also a controlled substance carries, in addition to this status, a Drug Enforcement Administration schedule (Schedules II through 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 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.