A BILL TO BE ENTITLED
AN ACT requiring pharmacies engaging in the compounding of drug products to obtain a compounding pharmacy permit and authorizing the north carolina board of pharmacy to impose a fee for the permit under the laws regulating the practice of pharmacy.
The General Assembly of North Carolina enacts:
SECTION 1.  Article 4A of Chapter 90 of the General Statutes is amended by adding the following new section to read:
"§ 90‑85.21C.  Compounding pharmacy permit; exemptions.
(a)	In addition to registration pursuant to G.S. 90‑85.21 or G.S. 90‑85.21A, every pharmacy that engages in the compounding activities described in this subsection shall register annually with the Board on a form provided by the Board and obtain a compounding pharmacy permit. The Board shall be entitled to charge and collect a fee not to exceed five hundred dollars ($500.00) for registration of a compounding pharmacy. This section shall apply to pharmacies that compound any of the following:
(1)	Capsules, suppositories, or other dosage forms from bulk active ingredients supplied in commercial quantities from chemical distributors.
(2)	Reconstitution or mixing of manufactured sterile components.
(3)	Compounded products containing cytotoxic ingredients, hormones, or other hazardous ingredients.
(4)	Sterile compounded products.
(b)	This section shall not apply to the following:
(1)	The reconstitution of antibiotic powders or granules.
(2)	The making of simple non‑sterile topical preparations from the mixing of commercially available products.
(3)	The occasional assembly, pursuant to a prescription order, of active ingredients commonly available from wholesale prescription drug distributors licensed by the North Carolina Department of Agriculture and Consumer Services.
(4)	Locations accredited by accrediting organizations approved by the Board."
SECTION 2.  G.S. 90‑85.32 reads as rewritten:
"§ 90‑85.32.  Rules pertaining to pharmacies, the compounding of drug products, and the filling, refilling, transfer, and mail or common‑carrier delivery of prescription orders.
(a)	Except as otherwise provided in this section, the Board may adopt rules regulating pharmacies, the compounding of drug products, and the filling, refilling and transfer of prescription orders not inconsistent with other provisions of law regarding the distribution of drugs and devices. The rules shall assure the safe and secure distribution of drugs and devices. Prescriptions marked PRN shall not be refilled more than one year after the date issued by the prescriber unless otherwise specified.
(b)	Notwithstanding G.S. 90‑85.6, the Board shall not adopt rules pertaining to the shipment, mailing, or other manner of delivery of dispensed legend drugs that are more restrictive than federal statutes or regulations governing the delivery of prescription medications by mail or common carrier."
SECTION 3.  This act is effective when it becomes law.