A2477

An Act concerning the dispensing of certain biological products and revising various parts of the statutory law, and supplementing chapter 6 of Title 24 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. (New section) As used in this act:

“Biological product” means a “biological product” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any 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.

“Biosimilar” means “biosimilar” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)), and refers to a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as biosimilar pursuant to section 351 of the Public Health Service Act (42 U.S.C. s.262) in terms of safety, purity, and potency of the product.

“Interchangeable” means “interchangeable” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)).

“Reference product” means a “reference product” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)), and refers to the single biological product against which a biological product is evaluated in an application for a license as a biosimilar biological product.

2. (New section) The Commissioner of Health shall maintain, and make available to each pharmacy practice site in the State without charge, a list of biosimilar biological products approved by the federal Food and Drug Administration to be interchangeable with a prescribed biological reference product, pursuant to section 351 of the Public Health Service Act (42 U.S.C. s.262).

3. (New section) a. A pharmacist may substitute a biosimilar biological product for a prescribed biological product if:

(1) the biosimilar biological product has been approved by the federal Food and Drug Administration to be interchangeable with the prescribed biological reference product; and

(2) the authorized prescriber has not indicated that there shall be no substitution by initialing the prescription blank next to “do not substitute.”

b. If a pharmacist substitutes an interchangeable biosimilar biological product for a prescribed biological reference product, the pharmacist shall:

(1) notify the patient in writing that the biological product dispensed has been approved by the federal Food and Drug Administration as an interchangeable biosimilar biological product for the prescribed biological reference product;

(2) provide electronic, written, or telephonic notification of the substitution to the authorized prescriber or the authorized prescriber’s staff within five business days after the dispensing of the interchangeable biosimilar biological product; and

(3) record, on the prescription label and record of dispensing, the product name of the interchangeable biosimilar biological product, followed by the words: “Substituted for” and the name of the biological reference product for which the prescription was written, and the manufacturer of the interchangeable biosimilar biological product.

c. Records of substitutions of interchangeable biosimilar biological products shall be maintained for at least five years after the dispensing date.

d. A pharmacist who substitutes an interchangeable biosimilar biological product in compliance with this section shall incur no greater liability in filling the prescription by dispensing the interchangeable biosimilar biological product than would be incurred in filling the prescription by dispensing the prescribed biological reference product.

4. R.S.24:1-1 is amended to read as follows:

24:1.1As used in this Title:

a. “State department,” “department of health” and “department” mean the “State Department of Health.”

b. “Council” means the Public Health Council in the State Department of Health.

c. “Local board” or “local board of health” means the board of health of any municipality, or the boards, bodies, or officers in such municipality lawfully exercising the powers of a local board of health under the laws governing such municipality, and includes any consolidated local board of health or county local board of health created and established pursuant to law.

d. “Food” means (1) articles used for food or drink for man or other animals (2) chewing gum and (3) articles used for components of any such article.

e. “Drug” means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include biological products, or devices or their components, parts, or accessories.

f. “Package” or “container” means wrapper, case, basket, hamper, can, bottle, jar, tube, cask, vessel, tub, firkin, keg, jug, barrel, or other receptacles, but the word, “package” shall not include open containers which permit a visual and physical inspection by the purchaser at retail, nor bags and other receptacles which are filled in the presence of the purchaser at retail.

g. “Device” means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.

h. “Cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

i. “New drug” means (1) any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and (2) any drug the composition of which is such that such drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

j. “Label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this subtitle that any word, statement or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. The term “immediate container” does not include package liners.

k. “Labeling” means all labels and other written, printed or graphic matter (1) upon an article or any of its containers or wrappers, or (2) accompanying such article.

l. “Official compendium” means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.

m. If an article is alleged to be misbranded because the labeling is misleading, then in determining whether such labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, or any combination thereof, but also the extent to which such labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which such labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.

n. The representation of a drug as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.

o. The provisions of this act regarding the selling of food, drugs, devices, or cosmetics, shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving away of any such article and the supplying or applying of any such articles in the conduct of any food, drug or cosmetic establishment.

p. The term “Federal Act” means the Federal Food, Drug and Cosmetic Act (Title 21, U.S.C. 301 et seq.; 52 Stat. 1040 et seq.).

(cf: P.L.1966, c.74, s.1)

5. Section 5 of P.L.1977, c.240 (C.24:6E-4) is amended to read as follows:

5. As used in this act unless the context clearly indicates otherwise:

a. “Drug product” means a dosage form containing one or more active therapeutic ingredients along with other substances included during the manufacturing process. The term “drug product” does not include “biological product” as defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

b. “Brand name” means the proprietary name assigned to a drug by the manufacturer thereof.

c. “Established name” with respect to a drug or ingredient thereof, means (1) the applicable official name designated pursuant to the Federal Food, Drug and Cosmetic Act (Title 21, U.S.C. s.301 et seq.), or (2) if there is no such official name and such drug or ingredient is recognized in an official compendium, then the official title thereof in such compendium, except that where a drug or ingredient is recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply, or (3) if neither (1) nor (2) is applicable, then the common or usual name, if any, of such drug or ingredient.

d. “Prescription” means an order for drugs or combinations or mixtures thereof, written or signed by a duly licensed physician, dentist, veterinarian, or other medical practitioner licensed to write prescriptions intended for the treatment or prevention of disease in man or animals, and includes orders for drugs or medicines or combinations or mixtures thereof transmitted to pharmacists through word of mouth, telephone, telegraph, or other means of communication by a duly licensed physician, dentist, veterinarian, or other medical practitioner licensed to write prescriptions intended for the treatment or prevention of disease in man or animals.

e. “Department” means the Department of Health.

f. “Chemical equivalents” means those drug products that contain the same amounts of the same therapeutically active ingredients in the same dosage forms and that meet present compendial standards.

g. “Reference drug product” means the product which is adopted by the department as the standard for other chemically equivalent drugs in terms of testing for the therapeutic equivalence. In all cases, the reference drug product shall be a currently marketed drug which is the subject of a full (not abbreviated) new drug application approved by the Federal Food and Drug Administration.

h. “Therapeutic equivalents” means chemical equivalents which, when administered to the same individuals in the same dosage regimen, will provide essentially the same efficacy or toxicity as their respective reference drug products.

i. “Bioavailability” means the extent and rate of absorption from a dosage form as reflected by the time-concentration curve of the administered drug in the systemic circulation.

j. “Bioequivalents” means chemical equivalents which, when administered to the same individuals in the same dosage regimen, will result in comparable bioavailability.

k. “Pharmaceutical equivalents” means those drug products that contain the same amounts of the same therapeutically active ingredients in the same dosage form and that meet established standards.

l. “Interchangeable drug products” means pharmaceutical equivalents or bioequivalents that are determined to be therapeutic equivalents by the department.

m. “Present compendial standards” means the official standards for drug excipients and drug products listed in the latest revision of the United States Pharmacopoeia (USP) and the National Formulary (NF).

n. “Dosage form” means the physical formulation or medium in which the product is intended, manufactured and made available for use, including, but not limited to: tablets, capsules, oral solutions, aerosols, inhalers, gels, lotions, creams, ointments, transdermals and suppositories, and the particular form of the above which utilizes a specific technology or mechanism to control, enhance, or direct the release, targeting, systemic absorption, or other delivery of a dosage regimen in the body.

(cf: P.L.2012, c.17, s.87)

6. The Commissioner of Health, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations necessary to implement the provisions of this act.

7. This act shall take effect on the first day of the second month next following the date of enactment, but the Commissioner of Health may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of the act.

STATEMENT

The “Patient Protection and Affordable Care Act,” Pub.L.111-148, amended the federal Public Health Service Act to create an abbreviated licensure pathway for biological products demonstrated to be biosimilar to, or interchangeable with, biological products licensed by the federal Food and Drug Administration (FDA). This bill allows for the substitution of these products by pharmacists, provided the conditions set forth in the bill are met.

Specifically, the bill directs the Commissioner of Health to maintain, and make available to each pharmacy practice site in the State without charge, a list of biosimilar biological products approved by the FDA to be interchangeable with a prescribed biological reference product. A pharmacist may substitute such a product for a prescribed biological product if the prescriber has not indicated that there be no substitution by initialing the prescription blank next to “do not substitute. A pharmacist who dispenses an interchangeable biosimilar product is to notify the patient in writing that the dispensed biological product has been approved by the FDA as an interchangeable biosimilar biological product, and notify the prescribing practitioner of the substitution within five business days after dispensing. The pharmacist is to record, on the prescription label and dispensing record, the product name of the interchangeable biosimilar biological product, followed by the words: “Substituted for” and the name of the biological reference product for which the prescription was written, as well as the manufacturer of the interchangeable biosimilar biological product. Records of substitutions are to be maintained for at least five years after the dispensing date. The bill provides immunity from liability for a pharmacist who makes such substitutions in compliance with the bill to the same extent that immunity would be provided for dispensing the prescribed biological reference product.

The bill incorporates the definitions used in relevant federal law for the terms “biological product,” “biosimilar,” “biological reference product,” and “interchangeable.” Generally, “biological products” are made from various sources, including human, animal or microorganism, and are intended to treat medical conditions, or prevent or diagnose diseases. “Biosimilar” means that data show that a product is “highly similar” to an already-approved biological product. “Reference product” refers to the single biological product against which a biological product is evaluated in an application to be licensed as biosimilar or interchangeable.

The bill also amends the definitions of “drug” in R.S.24:1-1 and “drug product” in section 5 of P.L.1977, c.240 (C.24:6E-4) to clarify that those terms do not include “biological product.” The bill takes effect on the first day of the second month next following the date of enactment.