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§1304.26. Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid. — Inbound Citations

21 C.F.R. § 1304.26

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 1304.26 as a whole

  • (c) Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser. In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription must also comply with § 1304.26.