N.J. Stat. tit. 24, ch. 6E

in effect

N.J. Stat. § 24:6E-1 Short title

This act shall be known and may be cited as the "Prescription Drug Price and Quality Stabilization Act." L.1977, c. 240, s. 1, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-2 Advertisement of prescription drugs; rules and regulations

In conformance with the Administrative Procedure Act, P.L.1968, c. 410 (C. 52:14B-1 et seq.), the Director of the Division of Consumer Affairs shall promulgate rules and regulations governing the advertising of prescription drugs. Such rules and regulations shall include, but shall not be limited to, the following: (1) provisions governing the content of advertisements, including price quotations in conformance with usual and customary prescription amounts, dosage form, and services offered; (2) provisions prohibiting reference to the quality of a drug or its beneficial use; (3) provisions prohibiting the advertising for sale of a prescription drug at a retail price below the acquisition cost of the drug to the retail seller; (4) provisions governing the mandatory dissemination over the telephone of price information. Such rules and regulations shall be consistent, insofar as practicable, with Federal laws and regulations concerning advertising of prescription drugs, and the director may make any such Federal law or regulation applicable to the advertising of prescription drugs within this State by rule or regulation. L.1977, c. 240, s. 3, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-3 Restraint on prescription drug price information to public

It shall be unlawful for any individual, group or association to restrain, directly or indirectly, the flow of prescription drug price information to the public. L.1977, c. 240, s. 4, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-4 Definitions.

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.2015, c.130 (C.24:6K-1). 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. L.1977, c.240, s.5; amended 1993, c.256; 2010, c.87, s.1; 2012, c.17, s.87; 2015, c.130, s.5.

N.J. Stat. § 24:6E-6 List of interchangeable drug products.

7. a. The department shall prepare a list of interchangeable drug products. This list shall be periodically reviewed in accordance with a schedule of and procedure for such review as shall be established by the department. In development of the list, distinctions shall be made when: (1) evidence of bioequivalence is considered critical and when it is not; (2) when levels of toxicity are considered critical and when they are not. The list may include interchangeable drug products used by the United States Government and its agencies, where the government or such agency has established the reliability of the drug products interchanged. b. No drug products shall be included in such list until after a public hearing has been held thereon after at least 20 days' notice. Such notice shall be mailed to every drug company that is authorized to do business in the State of New Jersey and to all persons who have made a timely request of the department for advance notice of its public hearings and shall be published in the New Jersey Register. c. Manufacturers shall, upon the request of the department, be required to submit any information in their files that relates manufacturing processes and in vivo and in vitro tests to the bioavailability of any drug product. This requirement shall also apply to technical information obtained during research related to the development of new drug products, even when such information bears only an indirect relationship to the final dosage form. The department shall not make such information public when there is a proprietary interest on the part of the manufacturer. d. Any manufacturer of drug products shall have the right to request the department to evaluate its drug products for the purpose of inclusion on the list of interchangeable drug products, or to request that the department consider removal of any drug product from the list. Any such request shall be accompanied by such information as the department shall require, and any drug product involved shall be evaluated in the same manner and shall be subject to the same procedures and requirements as all other drug products evaluated by the department for inclusion on or removal from the list. e. Prior to any drug product being approved by the department, the manufacturer shall be required to demonstrate that it has complied with the standards set forth in the Current Good Manufacturing Practices of Title 21 U.S.C. or in such standards relating to drug manufacturing practices as may be promulgated by the department from time to time and must show evidence of a satisfactory inspection by the Federal Food and Drug Administration or the department. f. The department shall distribute copies of the list of interchangeable drug products and revisions thereof and additions thereto among physicians and other authorized prescribers and licensed pharmacists, and shall supply a copy to any person upon request, upon payment of the price established by the department. g. The department shall be authorized to adopt reasonable rules and regulations, in accordance with the provisions of the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to carry out its functions and duties under this act and to effectuate its purposes. L.1977, c.240, s.7; amended 2010, c.87, s.2.

N.J. Stat. § 24:6E-7 Prescriptions; dispensation of lowest cost interchangeable drug product; exceptions; notice of substitution

Every prescription blank shall be imprinted with the words, "substitution permissible" and "do not substitute" and shall contain space for the physician's or other authorized prescriber's initials next to the chosen option. Notwithstanding any other law, unless the physician or other authorized prescriber explicitly states that there shall be no substitution when transmitting an oral prescription or, in the case of a written prescription, indicates that there shall be no substitution by initialing the prescription blank next to "do not substitute," a different brand name or nonbrand name drug product of the same established name shall be dispensed by a pharmacist if such different brand name or nonbrand name drug product shall reflect a lower cost to the consumer and is contained in the latest list of interchangeable drug products published by the council; provided, however, where the prescriber indicates "substitution permissible, and requests the pharmacist to notify him of the substitution," the pharmacist shall transmit notice, either orally or by written notice to be mailed no later than the end of the business day, to the prescriber specifying the drug product actually dispensed and the name of the manufacturer thereof. However, no drug interchange shall be made unless a savings to the consumer results, and the pharmacist passes such savings on to the consumer in full by charging no more than the regular and customary retail price for the drug to be substituted. For prescriptions filled other than by mail, the consumer may, if a substitution is indicated and prior to having his prescription filled, request the pharmacist or his agent to inform him of the price savings that would result from substitution. If the consumer is not satisfied with said price savings he may, upon request, be dispensed the drug product prescribed by the physician. The pharmacist shall make a notation of such request upon the prescription blank. L.1977, c. 240, s. 8, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-8 Prescriptions; dispensation of substitute drug for drug not on latest list of interchangeable drug products; reasons; approval of prescriber

Notwithstanding any other law, where a different brand name or nonbrand name drug product of the same established name shall reflect a lower cost to the consumer and no drug product of such established name is included in the latest list of interchangeable drug products published by the council, or where in the professional judgment of the pharmacist there is no valid proof of efficacy for the drug product prescribed, or the pharmacist's patient profile record discloses drug sensitivity, allergies or adverse reactions to the drug product prescribed, or there exists a more appropriate drug product than the drug product prescribed, a different brand name or nonbrand name drug product shall be dispensed by the pharmacist, provided, however, that such action by a pharmacist shall be authorized only if in each case the pharmacist notifies the prescriber of the drug product to be dispensed and the name of the manufacturer thereof, and receives the approval of the prescriber to substitute such drug product for the drug product prescribed. The pharmacist shall be required to indicate on the prescription the date and time of the prescriber's approval and whether the approval was communicated orally or in writing. L.1977, c. 240, s. 9, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-9 Dispensation of nonbrand name drug product; label.

10. If a nonbrand name drug product is dispensed, the pharmacist shall include on the label of such drug product dispensed pursuant to a prescription, the name of the brand name drug and the name of the generic drug. The information required pursuant to this section shall be in the following form, with the generic name and brand name inserted as appropriate: "-------_Generic for -------". L.1977, c.240, s.10; amended 2009, c.91, s.1.

N.J. Stat. § 24:6E-10 Signs, information to be disclosed relative to drugs, biological products to be dispensed.

11. Every pharmacy, drug store, or drug department selling prescription drugs or biological products shall post a sign at the entrance and where prescription drugs or biological products are sold disclosing the fact that upon request, before a prescription drug or biological product is dispensed, a consumer shall be told the price of such drug or biological product, whether such drug or biological product is to be substituted from a list of interchangeable drug or biological products, and of the consumer's right to be informed of the price savings resulting from substitution for such drug or biological product and to be dispensed the drug or biological product as prescribed by the physician, if not satisfied with said price savings. Such sign shall not be less than 12 inches by 12 inches. L.1977, c.240, s.11; amended 2015, c.130, s.6.

N.J. Stat. § 24:6E-11 Violations; penalties; collection and enforcement; validity of prescription on unauthorized form

Any person violating any provision of this act shall be liable to a penalty of not less than $100.00 for the first offense, and not less than $200.00 for each subsequent offense. Such penalty shall be collected and enforced by summary proceedings pursuant to the Penalty Enforcement Law (N.J.S. 2A:58-1 et seq.). Process shall issue at the suit of the Board of Pharmacy or the Attorney General, and shall be either in the nature of a summons or warrant. In addition, the Board of Pharmacy may suspend or revoke the certificate of a registered pharmacist for violating any provision of this act. However, failure of the prescriber to utilize the form of prescription designated in section 8 of this act shall not invalidate the prescription as written, if said prescription is otherwise valid. L.1977, c. 240, s. 12, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-12 Inapplicability of act to dispensation of drug permits under institutional permits

The provisions of sections 5 through 12 shall not be applicable to drug products dispensed under institutional permits when the institution involved has its own drug substitution mechanism. L.1977, c. 240, s. 13, eff. Sept. 29, 1977.

N.J. Stat. § 24:6E-13 Severability

If any provision of this act or the application thereof to any person or circumstance is held invalid, such invalidity shall not affect any other provision or application of the act which can be given effect without such invalid provision or application, and to this end the provisions of this act are declared to be severable. L.1977, c. 240, s. 14, eff. Sept. 29, 1977.

Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://www.njleg.state.nj.us/legislative-activity/statutesFetched: 10/17/2026