References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a), (b), (d), and (e)(1), is
[act June 25, 1938, ch. 675], [52 Stat. 1040], which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in section 812(c) of this title.
[Pub. L. 114–198] added subsec. (f).
[Pub. L. 110–425] added subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
[Pub. L. 110–425] effective 180 days after Oct. 15, 2008, except as otherwise provided, see [section 3(j) of Pub. L. 110–425], set out as a note under section 802 of this title.
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see
[section 704 of Pub. L. 91–513], set out as a note under section 801 of this title.
Construction of 2016 Amendment
[Pub. L. 114–198, title VII, § 702(b)], July 22, 2016, [130 Stat. 741], provided that: “Nothing in this section [amending this section] shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled.”
Dispensation of Narcotic Drugs for the Purpose of Relieving Acute Withdrawal Symptoms From Opioid Use Disorder
[Pub. L. 116–215, div. B, title III, § 1302], Dec. 11, 2020, [134 Stat. 1046], provided that: “Not later than 180 days after the date of enactment of this Act [Dec. 11, 2020], the Attorney General shall revise section 1306.07(b) of title 21, Code of Federal Regulations, so that practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person’s use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both).”
Programs and Materials for Training on Certain Circumstances Under Which a Pharmacist May Decline To Fill a Prescription
[Pub. L. 115–271, title III, § 3212], Oct. 24, 2018, [132 Stat. 3947], as amended by [Pub. L. 117–328, div. FF, title I, § 1271(a)], Dec. 29, 2022, [136 Stat. 5685], provided that:
The Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022 [Dec. 29, 2022], and update periodically thereafter, as appropriate, materials for pharmacists, health care providers, and patients on—
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.
In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—
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.
Materials for Training on Verification of Identity.—
Not later than 1 year after the date of enactment of this subsection [Dec. 29, 2022], the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—
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.”
Effect of Scheduling on Prescriptions
[Pub. L. 101–647, title XIX, § 1902(c)], Nov. 29, 1990, [104 Stat. 4852], provided that any prescription for anabolic steroids subject to refill on or after Nov. 29, 1990, could be refilled without restriction under subsec. (a) of this section.