Revision: March 23, 2018, 11:43 a.m.
SB 350 - AS AMENDED BY THE SENATE
SENATE BILL 350
SPONSORS: Sen. Innis, Dist 24; Sen. Avard, Dist 12; Sen. Fuller Clark, Dist 21; Sen. Hennessey, Dist 5; Rep. T. Wolf, Hills. 7; Rep. L. Ober, Hills. 37; Rep. Weber, Ches. 1
COMMITTEE: Health and Human Services
This bill establishes requirements for dispensing and substituting biological products by pharmacists.
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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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
03/22/2018 1125s 18-2758
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Eighteen
AN ACT relative to biological products dispensed by pharmacists.
Be it Enacted by the Senate and House of Representatives in General Court convened:
318:47-a Prescription Labels. Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he or she 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. A biological product, as defined in RSA 318:47-dd, I, shall also be labeled as provided in RSA 318:47-dd, VII. 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, 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.
318:47-d Pharmacies; Substituting Generic Drugs. Pharmacies, including mail-order pharmacies, may substitute generically equivalent drug products for all legend and non-legend prescriptions unless the prescribing practitioner handwrites "medically necessary'' on each paper prescription, or uses electronic indications when transmitted electronically, or gives instructions when transmitted orally that the brand name drug product is medically necessary. In this section, "drug product" does not include a biological product.
318:47-dd Pharmacies; Substituting Biological Products.
I. In this section:
(a) "Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
(b) "Proper name" means the nonproprietary name for a biological product designated by the federal Food and Drug Administration license for use upon each package of the product.
(c) "Interchangeable biological product" means a biological product that the federal Food and Drug Administration:
(1) Has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. section 262(k)(4); or
(2) Has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations.
II. The board shall maintain a link on its website to the federal Food and Drug Administration's Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.
III. A pharmacist shall substitute a biological product pursuant to this section only if it has been licensed by the federal Food and Drug Administration as an interchangeable biological product for the prescribed biological product.
IV. When a pharmacist dispenses an interchangeable biological product for the prescribed biological product, the pharmacist or his or her designee shall inform the patient.
V. A pharmacist shall not substitute an interchangeable biological product pursuant to this section if the prescriber indicates that substitution is not authorized by specifying on the prescription "medically necessary" on a paper prescription, or uses electronic indications when transmitted electronically, or gives instructions when transmitted orally that the biological product prescribed is medically necessary.
VI.(a) Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry that is electronically accessible to the prescriber through:
(1) An interoperable electronic medical records system;
(2) An electronic prescribing technology; or
(3) A pharmacy benefit management system; or
(4) A pharmacy record.
(b) Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that the communication shall not be required where:
(1) There is no federal Food and Drug Administration-approved interchangeable biological product for the biological product prescribed; or
(2) A refill prescription is not changed from product dispensed on the prior filling of the prescription.
VII. The label of all biological products dispensed by a pharmacist shall include the proper name and the name of the manufacturer of the product.