Nev. Admin. Code § 639.757

Current through December 12, 2024
Section 639.757 - Preparation and sale of compounded drugs by pharmacy or pharmacist: License as manufacturer not required under certain circumstances; unsafe or ineffective drug; restrictions on sale
1. A pharmacy, pharmacist or dispensing practitioner is not required to obtain a license as a manufacturer to compound drugs if:
(a) The compounded drugs are prepared in a quantity that is:
(1) Necessary to fill a prescription or chart order; or
(2) Reasonably necessary to fill future prescriptions or chart orders based upon the previous history of practitioners and patients who regularly use the pharmacy or dispensing practitioner;
(b) The compounded drugs are not sold or otherwise provided by the pharmacy, pharmacist or dispensing practitioner to any person other than the ultimate user of the drugs or the agent of the ultimate user of the drugs; and
(c) The compounded drugs are dispensed pursuant to a prescription or chart order.
2. In compounding a drug product, a pharmacy, pharmacist or dispensing practitioner shall use bulk drug substances in compliance with 21 U.S.C. § 353a, as applicable.
3. Except as otherwise provided in this subsection, a pharmacy, pharmacist or dispensing practitioner shall not compound a drug that has been withdrawn or removed from the market because the drug was found to be unsafe or ineffective. A pharmacy, pharmacist or dispensing practitioner may compound a drug for veterinary use that has been withdrawn or removed from the market because the drug was found to be unsafe or ineffective for use in humans if the drug remains available for veterinary use.

Nev. Admin. Code § 639.757

Added to NAC by Bd. of Pharmacy by R032-02, eff. 5-31-2002; A by R035-06, 9-18-2008; A by R100-23A, eff. 6/10/2024; A by R053-24A, eff. 10/23/2024

NRS 639.070