---
kind: "section"
citation: "21 C.F.R. § 1304.26"
title: "21"
number: "1304.26"
heading: "Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid."
url: "https://uscodex.org/cfr/21/1304.26"
---

# §1304.26. Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.


In addition to the recordkeeping requirements for dispensers and researchers provided in [§ 1304.22](/cfr/21/1304.22.md), practitioners dispensing gamma-hydroxybutyric acid that is manufactured or distributed in accordance with an application under [section 505](/cfr/21/505.md) of the Federal Food, Drug, and Cosmetic Act must maintain and make available for inspection and copying by the Attorney General, all of the following information for each prescription:

- (a) **Name of the prescribing practitioner.**
- (b) Prescribing practitioner's Federal and State registration numbers, with the expiration dates of these registrations.
- (c) Verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance.
- (d) **Patient's name and address.**
- (e) **Patient's insurance provider, if available.**

## Notes

### Amendments

[70 FR 293, Jan. 4, 2005]

### Authority

Authority: 21 U.S.C. 821, 823(j), 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.

### Amendments

[70 FR 293, Jan. 4, 2005]