The Food and Drug Administration (FDA) is changing its regulations regarding certain statements required on the labels of prescription drugs in general and on certain narcotic or hypnotic drugs (which are addictive). The Agency is taking this action in accordance with the provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). This final rule revises the FDA`s labelling regulations under the Modernization Act. Since the application of these labelling provisions falls within the competence of the federation, this rule should have little, if any, impact on states, on relations between national governments and states, or on the distribution of powers and responsibilities between different levels of government. Furthermore, the FDA does not believe that this final rule prejudges existing state law. An increasing number of drugs limited to prescription purposes only are labeled exclusively in Spanish for distribution in the Commonwealth of Puerto Rico, where Spanish is the predominant language. Such marking is permitted under Section 201.15(c). A mandatory warning, the wording of which is established by law in English, could be translated in a variety of ways, from literal to loose interpretation. The legal nature of this warning requires that the translation adequately convey the meaning in order to avoid confusion and dilution of the purpose of the warning. Section 503(b)(4) of the Federal Food, Drugs and Cosmetics Act requires at least that the label be marked “Rx only”. The Spanish version of this should be “Solamente Rx”. For more information on drugs for human use: Jerry Phillips, Center for Drug Evaluation and Research (HFD-400), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3246.
(1). The four comments concerned the appearance of the words `Rx only` on the label. In the proposed rule, the symbol ℞ appeared in bold due to compositional restrictions. The FDA didn`t want to give the impression that it was proposing to bold the ℞ symbol. In an attempt at clarification, a footnote was included in the proposed rule stating: “The symbol ℞ appears in bold in this document due to compositional restrictions, but should not be printed in bold when used on the product label” (65 FR 21378). Two comments opposed this apparent ban on the use of bold and noted that the implementation guidelines discussed in section IV of this document did not prescribe whether the symbol ℞ or the pure Rx statement should generally be printed in bold. The FDA agrees with these comments. The ℞ symbol and the pure Rx statement can be printed in bold or in a normal font. The prescribing physician must submit a written and signed prescription for the oral emergency order in accordance with Schedule II within 7 days.1 This order must include the words “Emergency Issuance Authorization” on the front. The pharmacist must attach the written and signed prescription to the one previously reduced to writing.
If the prescribing physician does not present the pharmacy with a written and signed prescription for the List II drug within 7 days, the pharmacist must report the violation to the nearest local DEA office. Failure to report the violation may result in the revocation of the pharmacist`s authority to dispense without a written prescription. The label of a drug on the list of “controlled substances” in Schedule II, III or IV of the Federal Controlled Substances Act, when administered to or for a patient, must include the following warning: “Caution: Federal law prohibits the transfer of this drug to a person other than the patient to whom it was prescribed.” This information does not need to appear on the label of a controlled substance provided for use in “blind” clinical trials. As a result, the FDA has determined that this final rule does not include guidelines that have implications for federalism. Section 201.100 Prescription drugs for human use is amended in paragraph (b)(1) by adding the phrase “Warning: Federal law prohibits dispensing without a prescription” and by adding the phrase “Rx only” in its place.