318:14-a Compounding. –
I. Products that are not commercially available may be compounded for hospital or office use but shall not be resold or dispensed. Nonprescription items may be compounded upon order by a practitioner for sale as long as the labeling complies with RSA 318:47-a and the product is not a copy of, or similar to, prescription or nonprescription products. Except as provided in rules adopted under paragraph V for veterinarians, all compounding shall be done in compliance with the United States Pharmacopeia as defined by board of pharmacy rules.
II. The compound drug product shall bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration, and the prescription shall be filed at that pharmacy. Compounded prescription labels shall include the phrase "compounded per subscriber request" or a similar statement on the prescription label or through the use of an auxiliary label attached to the prescription container.
III. A pharmacist shall offer a compounded drug product to a practitioner for administration to an individual patient, in limited quantities. The compounded drug products are for practitioner administration only and shall not be re-dispensed. The pharmacist shall maintain records to indicate what compounded drug products were provided to the medical office or practice. Compounding pharmacies may advertise or otherwise promote the fact that they provide prescription compounding services, in accordance with state law and rules of the board, as well as applicable federal laws.
IV. Where a commercial drug shortage exists because a manufacturer is the only entity currently manufacturing a drug product of a specific strength, dosage form, or route of administration for sale in the United States, and the manufacturer cannot supply the drug product to the public or to practitioners for use, a pharmacist may compound a limited quantity using the active pharmaceutical ingredient and sell to a patient with a valid prescription from a valid prescriber. When the compounded drug product is sold to a medical office or practice it is for the practitioner to administer to patients, and shall not be for resale.
V. The board shall adopt rules under RSA 541-A concerning the regulation of compounding, including exceptions for veterinarians from compliance with the United States Pharmacopeia chapter 797.
VI. Labeling requirements pursuant to paragraph II shall not apply when medication is dispensed to institutionalized patients as provided under RSA 318:47-b.