Revision: Jan. 17, 2013, midnight
HB 313 – AS INTRODUCED
2013 SESSION
10/01
HOUSE BILL 313
AN ACT relative to the regulation of the compounding of drugs by pharmacists.
SPONSORS: Rep. D. Sullivan, Hills 42
COMMITTEE: Health, Human Services and Elderly Affairs
This bill provides for regulation of the compounding of drugs by pharmacists.
This bill is a request of the board of pharmacy.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
13-0730
10/01
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Thirteen
AN ACT relative to the regulation of the compounding of drugs by pharmacists.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Pharmacists; Definition of Compounding. Amend RSA 318:1, III-a to read as follows:
III-a. “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device as a result of a practitioner’s prescription drug order or initiative based on the pharmacist-patient-prescriber relationship in the course of professional practice or, for the purpose of, or as an incident, to research, teaching, or chemical analysis, but not selling or dispensing. “Compounding” also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. [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.] “Compounding” shall not include the reconstitution of powered formulations before dispensing.
2 Pharmacists; Definition of Manufacturing. Amend RSA 318:1, VIII to read as follows:
VIII. “Manufacturing” means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by large volume extraction from substances of natural origin, or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. [“Manufacturing” also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists to anyone other than a patient via a prescription, practitioners, or other persons.] Manufacturing shall be governed by Good Manufacturing Practices as adopted and enforced by the federal Food and Drug Administration.
3 Reference Added; Compounding. Amend RSA 318:14 to read as follows:
318:14 Pharmacy. A licensed pharmacist shall have the right to conduct a pharmacy for the compounding, according to the provisions of RSA 318:14-a, of medicines upon physicians’, dentists’, optometrists’, podiatrists’, veterinarians’, advanced practice registered nurses’, naturopathic doctors’, and physician assistants’ prescriptions and for the manufacture, sale, and distribution of drugs, medicines, and poisons.
4 New Section; Compounding. Amend RSA 318 by inserting after section 14 the following new section:
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. Non-prescription items may be compounded for over-the-counter sale if the labeling complies with state and federal requirements and the product is not a copy of, or similar to, prescription products. All compounding shall be done in compliance with United States Pharmacopeia standards.
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. All compounded prescription labels shall include a statement similar to “This medication was specifically compounded for you at the request of your practitioner.”
III. A pharmacist shall offer a compounded drug product to a practitioner for administration to an individual patient, in limited quantities, and without the intention for resale within the medical office or practice of the practitioner. 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 using the pure drug product 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 or dispensing within the practice.
V. The board shall adopt rules under RSA 541-A concerning the regulation of compounding.
5 Prescription Labels; Reference to Compounding Added. Amend RSA 318:47-a to read as follows:
318:47-a Prescription Labels. Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he shall affix to the container in which such drug is dispensed a label showing at least the name and address of the pharmacy and the name or initials of the dispensing pharmacist or pharmacist-in-charge; the prescription identification number assigned by the pharmacy; the date dispensed; any directions as may be stated on the prescription; the name of the prescribing practitioner; the name of the patient; all pertinent auxiliary labels; and, unless otherwise indicated by the prescribing physician, dentist, veterinarian, or advanced practice registered nurse, the name, strength, and quantity of the drug dispensed. All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities. No person shall alter, deface, or remove any label so affixed. A compounded drug product shall also be labeled as provided in RSA 318:14-a.
6 Effective Date. This act shall take effect January 1, 2014.