Federal · Title 21 — Food and Drugs
21 U.S.C. § 829: Prescriptions
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Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [ 21 U.S.C. 353(b) ]. Prescriptions shall be retained in conformity with the requirements of section 827 of this title . No prescription for a controlled substance in schedule II may be refilled. Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [ 21 U.S.C. 353(b) ]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner. No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose. Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] should be so considered because of its abuse potential, he shall so advise the Secretary and furnish to him all available data relevant thereto. No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or a covering practitioner. The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice. has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and is temporarily unavailable to conduct the evaluation of the patient. the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion. it is not prohibited by State law; the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law; the partial fill is requested by the patient or the practitioner that wrote the prescription; and the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. may be filled; and shall be filled not later than 30 days after the date on which the prescription is written. may be filled; and shall be filled not later than 72 hours after the prescription is issued. Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016 , a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled. circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances. pharmacists on how to verify the identity of the patient; pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)). In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain. update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of the patient; and disseminate, as appropriate, the updated materials.”
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