reglab/statecodes huggingface dataset:
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-9 - Confectionery adulterations

24:5-9. Confectionery adulterations
For the purposes of this subtitle, confectionery shall be deemed adulterated if it bears or contains any alcohol, or nonnutritive article or substance except harmless coloring, or if a coal-tar color one from a batch which has been certified under the Federal Act, harmless flavoring, harmless resinous glaze not in excess of 4/10 of 1%, natural gum and pectin; provided, that this paragraph shall not apply to any confectionery by reason of its containing less than 5% by volume of alcohol or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.
Amended by L.1939, c. 320, p. 777, s. 20, eff. Jan. 1, 1940; L.1966, c. 74, s. 6; L.1984, c. 134, s. 1, eff. Aug. 28, 1984.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-9.1 - Confectionery with more than 1/2 of 1% alcohol rendered unfit for beverage purposes; sale to person under legal age; label; sign in place of sale; violations; penalty

24:5-9.1. Confectionery with more than 1/2 of 1% alcohol rendered unfit for beverage purposes; sale to person under legal age; label; sign in place of sale; violations; penalty
a. Anyone who sells confectionery that contains more than 1/2 of 1% alcohol rendered unfit for beverage purposes to a person who is under the legal age for purchasing alcoholic beverages is guilty of a disorderly persons offense.
b. Any confectionery manufactured in this State that contains more than 1/2 of 1% alcohol rendered unfit for beverage purposes shall bear a label containing the statement: "Sale of this product to persons under the legal age for purchasing alcoholic beverages is unlawful" . A person who violates the provisions of this subsection is guilty of a disorderly persons offense.
c. No confectionery containing more than 1/2 of 1% alcohol rendered unfit for beverage purposes shall be sold in this State unless the product bears a label that meets the requirements of subsection b. of this section or a sign containing the statement: "Sale of confectionery containing more than 1/2 of 1% alcohol to persons under the legal age for purchasing alcoholic beverages is unlawful" is displayed at the place where the product is sold or offered for sale. A person who violates the provisions of this subsection is guilty of a disorderly persons offense.
L.1984, c. 134, s. 2, eff. Aug. 28, 1984.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-10 - General drug or device adulterations

24:5-10. General drug or device adulterations
For the purposes of this subtitle a drug or device shall be deemed adulterated:
a. (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch which has been certified under the Federal Act.
b. If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with tests or methods of assay set forth in such compendium or in the absence of or inadequacy of such tests or methods of assay, those prescribed by the agency enforcing the Federal Act. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
c. If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below that which it purports or is represented to possess.
d. If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its strength, quality, or purity; or (2) substituted wholly or in part therefor.
e. If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
Amended by L.1939, c. 320, p. 777, s. 21, eff. Jan. 1, 1940; L.1966, c. 74, s. 7.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-11 - Exceptions to drug adulterations

24:5-11. Exceptions to drug adulterations
No drug defined in an official compendium shall be deemed to be adulterated under section 24:5-10 because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label.
Amended by L.1939, c. 320, p. 778, s. 22, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-11.1 - General cosmetic adulterations

24:5-11.1. General cosmetic adulterations
For the purpose of this subtitle a cosmetic shall be deemed to be adulterated:
a. If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual; provided, that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness," and the labeling of which bears adequate directions for such preliminary testing. For the purpose of this paragraph and paragraph e the term "hair dye" shall not include eyelash dyes or eyebrow dyes.
b. If it consists in whole or in part of any filthy, putrid, or decomposed substance.
c. If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
d. If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
e. If it is not a hair dye and it bears or contains a coal-tar color other than one from a batch that has been certified under the Federal Act.
L.1939, c. 320, p. 779, s. 23, eff. Jan. 1, 1940; L.1966, c. 74, s. 8, eff. June 14, 1966.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-13 - Use of wood or methyl alcohol prohibited; penalty

24:5-13. Use of wood or methyl alcohol prohibited; penalty
No person shall sell or offer or expose for sale, or have in his possession with intent to distribute or sell, any food, drug, cosmetic, preparation or mixture of any kind, intended for internal use, which contains methyl or wood alcohol; nor shall any person sell, or offer or expose for sale, or have in his possession with intent to distribute or sell, or use upon or apply to the body of another, any drug, hair tonic, bay rum or similar preparation, intended for external use, which contains methyl or wood alcohol.
Any person who shall violate any of the provisions of this section shall be liable to a penalty of one hundred dollars for the first offense, two hundred dollars for the second offense, and three hundred dollars for the third and each subsequent offense.
Amended by L.1939, c. 320, p. 779, s. 24, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-14 - Meat and meat products

24:5-14. Meat and meat products
No person shall distribute or sell or have in his possession with intent to distribute or sell any meat or meat product to which any sodium sulphite, sodium bisulphite, or any drug, chemical, chemical compound or preservative, from which sulphur dioxide can be liberated, has been added thereto or mixed therewith.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-16 - "Misbranded" defined

24:5-16. "Misbranded" defined
The term "misbranded" as used in this subtitle shall apply to all drugs, articles of food, cosmetics and devices and to articles which enter into the composition of foods, drugs, cosmetics or devices, the package or label of which shall bear any statement or design regarding such article or the ingredients or substances contained therein, which shall be false or misleading in any particular, and to any food or drug product, or cosmetic, or device which is falsely branded as to the State, territory or country in which it is manufactured or produced.
Amended by L.1939, c. 320, p. 780, s. 25, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-18.1 - Cosmetic misbrandings

24:5-18.1. Cosmetic misbrandings
For the purposes of this subtitle a cosmetic shall also be deemed to be misbranded:
a. If its labeling is false or misleading in any particular.
b. If in package form unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor.
c. If any word, statement, or other information required by or under authority of this subtitle to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
d. If its container is so made, formed, or filled as to be misleading.
L.1939, c. 320, p. 785, s. 28, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-18.2 - Exemptions from labeling and packaging requirements

24:5-18.2. Exemptions from labeling and packaging requirements
Foods, drugs, devices, and cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed shall be exempted from the labeling and packaging requirements of this subtitle on such conditions as the State Department by regulations shall specify; provided, that such food, drugs, devices and cosmetics are not adulterated or misbranded under the provisions of this subtitle upon removal from such processing, labeling or repacking establishment.
L.1939, c. 320, p. 785, s. 29, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-19 - Drugs dispensed by physicians, etc., or on written prescription

24:5-19. Drugs dispensed by physicians, etc., or on written prescription
Nothing contained in this subtitle, except the provisions of section 24:5-10, shall be construed to apply to (1) any drug personally dispensed by any legally licensed physician, dentist or veterinarian in the course of his practice, or (2) any drug dispensed on a written prescription signed by a physician, dentist, or veterinarian (except a drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail), if (a) such physician, dentist, or veterinarian is licensed by law to administer such drug, and (b) such drug bears a label containing the name and place of business of the dispenser, the serial number and date of such prescription, and the name of such physician, dentist, or veterinarian.
Amended by L.1939, c. 320, p. 786, s. 30, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5-23 - Permit to process, manufacture product with hemp, transportation.

24:5-23 Permit to process, manufacture product with hemp, transportation.
9. a. A State agency may not prohibit a person or business entity that processes or manufactures a product regulated by the agency from applying for or obtaining a permit or other authorization to process or manufacture the product solely on the basis that the person or business entity intends to process or manufacture the product with hemp.
b. Hemp, hemp products, and hemp derivatives, including hemp-derived cannabidiol, produced in accordance with P.L.2019, c.238 (C.4:28-6 et al.) and any rules or regulations adopted pursuant thereto, shall not be considered controlled substances or additives and hemp, hemp products, or hemp derivatives, including hemp-derived cannabidiol may be added as an ingredient to cosmetics, personal care products, or products intended for human or animal consumption.
c. The provisions of P.L.2019, c.238 (C.4:28-6 et al.) applicable to hemp producers shall not apply to the possession, handling, transport, or sale of hemp products, including those containing one or more hemp-derived cannabinoids, including cannabidiol. Notwithstanding any other law, a person or business entity may possess, transport, sell, and purchase legally produced hemp products in this State. As part of the rules and regulations adopted pursuant to P.L.2019, c.238 (C.4:28-6 et al.), the Department of Agriculture shall provide to a retailer of hemp products notice of a potential violation concerning hemp products sold by the retailer and shall provide an opportunity to cure a violation committed unintentionally or negligently.
d. The Department of Agriculture, in consultation with the Department of Health, may adopt rules and regulations only to regulate the sale of hemp products that provide that:
(1) hemp-derived cannabinoids, including cannabidiol, are not considered controlled substances or adulterants; and
(2) products containing one or more hemp-derived cannabinoids, such as cannabidiol, intended for ingestion are to be considered foods, not controlled substances or adulterated products to the maximum extent permitted by federal law.
e. Retail sales of hemp products processed outside the State may be conducted in the State when the products and the hemp used in the products were processed and cultivated legally in another state or jurisdiction that has the same or substantially similar requirements for processing hemp products or cultivating hemp as provided by P.L.2019, c.238 (C.4:28-6 et al.).
f. Hemp products may be legally transported across State lines and exported to foreign countries in a manner that is consistent with federal law and the laws of respective foreign countries.
L.2019, c.238, s.9.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-3 - Hazardous substance; limitation

24:5A-3. Hazardous substance; limitation
The term "hazardous substance" shall not apply to economic poisons subject to "The Economic Poison Act of 1951" nor to foods, drugs, cosmetics and devices subject to the provisions of subtitle 1 of Title 24 of the Revised Statutes relating to these products, nor to substances intended for use as fuels when stored in suitable containers and used in the heating, cooking, or refrigeration system of a house, nor to substances subject to control under the Atomic Energy Commission Act of 1954 as amended, or the Radiation Protection Act of New Jersey (chapter 116, P.L.1958).
L.1966, c. 262, s. 3.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-4 - Application of Federal Hazardous Substances Labeling Act

24:5A-4. Application of Federal Hazardous Substances Labeling Act
No hazardous substance subject to and conforming with the Federal Hazardous Substances Labeling Act and regulations promulgated thereunder shall be deemed to be in violation of this act and regulations promulgated hereunder.
L.1966, c. 262, s. 4.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-5 - Commissioner; powers

24:5A-5. Commissioner; powers
(a) The commissioner is hereby empowered to promulgate such regulations as may be necessary for the efficient enforcement of this act after public hearing to be held after 30 days prior notice thereof by public advertisement of the date, time and place of such hearing.
(b) Whenever in the judgment of the commissioner such action will promote the objectives of this act by avoiding or resolving uncertainty as to its application, the commissioner may by regulation declare to be a hazardous substance, for the purposes of this act, any substance or mixture of substances which he finds meets the requirements of section 2(d).
(c) If the commissioner finds that the requirements of section 2(m) are not adequate for the protection of the public health and safety in view of special hazard presented by any particular hazardous substance, he may by regulation establish such reasonable variations or additional label requirements as he finds necessary for the protection of the public health and safety; and any container of such hazardous substance intended or suitable for household use which fails to bear a label in accordance with such regulations shall be deemed to be a misbranded package of a hazardous substance.
(d) If the commissioner finds that, because of the size of the package involved or because of the minor hazard presented by the substance contained therein, or for other good and sufficient reasons, full compliance with the labeling requirements otherwise applicable under this act is impracticable or is not necessary for the adequate protection of the public health and safety, the commissioner shall promulgate regulations exempting such substances from these requirements to the extent he determines to be consistent with adequate protection of the public health and safety.
(e) The commissioner may exempt from the requirements established by or pursuant to this act any container of a hazardous substance with respect to which he finds adequate requirements satisfying the purposes of this act have been established by or pursuant to and in compliance with any other Federal or State law.
(f) In the preparation of regulations for promulgation under this act, the commissioner shall take into consideration the requirements of regulations promulgated under the Federal Hazardous Substances Labeling Act and consult with the Commissioner of the Department of Labor and Industry.
L.1966, c. 262, s. 5.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-6 - Prohibited acts

24:5A-6. Prohibited acts
The following acts and the causing thereof are hereby prohibited:
(a) The selling, offering for sale or keeping for sale within this State of any misbranded package.
(b) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a hazardous substance being held for sale if such act results in the hazardous substance being in a misbranded package.
(c) The selling, offering for sale or keeping for sale of a hazardous substance in a reused food, drug or cosmetic container or in a container which though not a reused container is identifiable as a food, drug or cosmetic container by its labeling or by other identification.
(d) The use by any person to his own advantage, or revealing other than to the commissioner or officers or employees of the department, or to the courts when relevant in any judicial proceeding under this act, of any information acquired concerning any method or process which as a trade secret is entitled to protection.
L.1966, c. 262, s. 6.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-7 - Exceptions

24:5A-7. Exceptions
This act shall not apply to:
(a) Any carrier, while lawfully engaged in transporting a hazardous substance within this State, if such carrier shall, upon request, permit the commissioner or his designated agent to copy all records showing the transactions in and movements of the articles.
(b) Public officials of this State and of the Federal Government engaged in the performance of their official duties.
(c) The manufacturer or shipper of a hazardous substance for experimental use only:
(1) By or under the supervision of an agency of this State or of the Federal Government authorized by law to conduct research in the field of hazardous substances; or
(2) By others if the hazardous substance is not sold and if the container thereof is plainly and conspicuously marked "For experimental use only--Not to be sold" together with the manufacturer's name and address; provided, however, that if a written permit has been obtained from the commissioner, hazardous substances may be sold for experimental purposes subject to such restrictions and conditions as may be set forth in the permit.
L.1966, c. 262, s. 7.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-8 - Enforcement of act; penalties

24:5A-8. Enforcement of act; penalties
(a) The department shall execute and enforce the provisions of this act and in that enforcement is hereby vested with all powers relating to inspection, sampling, condemnation and embargoing of hazardous substances granted to it with respect to food and drugs under subtitle 1, Title 24 of the Revised Statutes.
(b) If any person shall violate directly or indirectly, through his officers or employees, any of the provisions of this act, or regulations promulgated hereunder, the commissioner may order the correction of the violation within such reasonable period of time as the commissioner may prescribe. Such order shall be complied with in the time specified.
(c) Any person violating any of the provisions of this act or orders or regulations promulgated hereunder shall be liable to a penalty of not less than $100.00 nor more than $1,000.00 and for the second and each succeeding violation, a penalty of not less than $200.00 nor more than $2,000.00 to be collected in a civil action by summary proceeding under "the penalty enforcement law" (N.J.S. 2A:58-1 et seq.). Where the violation is of a continuing nature, each day during which it continues, after the date given by which the violation must be eliminated in the order by the commissioner, shall constitute an additional, separate and distinct offense, except during the time an appeal from said order may be taken or is pending.
The commissioner is hereby authorized and empowered to compromise and settle any claim for a penalty under this section in such amount in the discretion of the commissioner as may appear appropriate and equitable under all of the circumstances.
(d) Payment of a penalty for any violation of this act or regulations promulgated hereunder either before or after the institution of proceedings for the collection thereof shall be deemed equivalent to a conviction of the violation for which such penalty was claimed.
L.1966, c. 262, s. 8. Amended by L.1983, c. 275, s. 3, eff. July 18, 1983.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:5A-9 - Action to restrain violations

24:5A-9. Action to restrain violations
The department either before or after the institution of a proceeding for the collection of a penalty for violation of any provision of this act or regulations promulgated thereunder may institute an action in the Superior Court in the name of the State at the relation of the department to restrain such violation and for such other or further relief as the court shall deem proper.
L.1966, c. 262, s. 9.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6-1 - Establishment of standards

24:6-1. Establishment of standards
If the definition or standard of identity, purity, quality, or strength of a particular food, drug, cosmetic or device has not been fixed by any law of this State, but such definition or standard has been or may hereafter be established under the Federal Act, the State Department of Health may adopt the definition or standard so established and published.
If such definition or standard shall be changed at any time by the agency administering the Federal Act, after the adoption of the definition or standard, it shall not continue in effect in this State after such change has become operative.
Amended by L.1939, c. 320, p. 786, s. 31, eff. Jan. 1, 1940; L.1966, c. 74, s. 11, eff. June 14, 1966.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6-2 - Publication: time of taking effect

24:6-2. Publication: time of taking effect
Such definition or standard shall be filed with the Secretary of State by the State Commissioner of Health, and shall be published at the end of the first volume of the session laws of the Legislature published after the filing of the definition or standard and shall take effect when so published.
Amended by L.1939, c. 320, p. 787, s. 32, eff. Jan. 1, 1940; L.1966, c. 74, s. 12.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6-3 - Sale or manufacture of nonstandard articles prohibited

24:6-3. Sale or manufacture of nonstandard articles prohibited
No person shall distribute or sell, or offer or expose for sale, or have in his possession with intent to sell, or manufacture for distribution or sale, any food, drug, cosmetic or device which differs in purity, quality or strength from the standards adopted and published in accordance with sections 24:6-1 and 24:6-2 of this Title.
Amended by L.1939, c. 320, p. 787, s. 33, eff. Jan. 1, 1940.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-1 - Registration statement, issuance of registration.

24:6B-1 Registration statement, issuance of registration.
1. No person shall hereafter engage or continue to engage in a drug manufacturing business or a wholesale non-prescription drug business in this State without first filing a completed registration statement with the department. The department shall promptly review completed registration statements. Within 30 days after receipt of a registration statement, the department shall either issue registration, or shall advise the registrant, in writing, of the specific deficiencies in the registration statement. Any supplemental materials, which are submitted in response to a notice of deficiency, shall be reviewed by the department within 30 days after receipt thereof.
L.1961, c.52, s.1; amended 2005, c.206, s.1; 2016, c.73, s.1.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-2 - Registration statement, signature, verification; form and contents.

24:6B-2 Registration statement, signature, verification; form and contents.
2. The registration statement shall be signed and verified by the individuals specified in subsection (c) hereof, shall be made on forms prescribed and furnished by the commissioner, and shall state such information necessary and proper to the enforcement of this act as the commissioner may require, consistent with the provisions of this section, including:
(a) The name under which the business is conducted.
(b) The address of each location in New Jersey at which the business is to be conducted. If a wholesale non-prescription drug business is not to be conducted from a location within the State, the statement shall give the name and address of an agent resident in this State on whom process against the registrant may be served.
(c) If the registrant is a proprietorship, the name and address of the proprietor; if a partnership, the names and addresses of all partners; if a corporation, the date and place of incorporation, the names and addresses of the president and secretary thereof, and the name and address of the designated registered agent in this State; or if any other type of business association, the names and addresses of the principals of such association.
(d) The names and addresses of those individuals having actual administrative responsibility, which, in the case of a proprietorship, shall be the managing proprietor; in the case of a partnership, shall be the managing partners; in the case of a corporation, shall be the officers and directors; or in the case of any other type of association, shall be those having similar administrative responsibilities.
(e) If the business will be conducted at more than one location in this State, the name and address of the individual in charge of each such location.
(f) A description of the business the registrant will be engaged in, and the drug products intended to be manufactured for sale or wholesale. If the registrant's products have not yet been approved by the federal Food and Drug Administration, the registrant shall submit a statement confirming that an application for approval has been submitted to the federal Food and Drug Administration, or that the registrant intends to file such an application within 12 months. Approval by the federal Food and Drug Administration shall not be a condition of registration.
(g) The name and address of the individual or individuals on whom orders of the commissioner may be served.
(h) A statement as to whether the registrant will be engaged in manufacturing, compounding, processing, wholesaling, jobbing, or distribution of depressant or stimulant drugs as defined pursuant to law.
L.1961, c.52, s.2; amended 1966, c.314, s.4; 2005, c.206, s.2; 2016, c.73, s.2.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-4 - Fee

24:6B-4. Fee
A fee shall accompany each registration statement. It shall be $200.00 if the business has less than 2 locations in this State, and $500.00 if the business has 2 or more locations in this State; except that where the gross total annual business in drugs of a registrant shall not exceed 3% of the gross total annual volume of the business of the registrant, as certified by a certified public accountant, the fee shall be $50.00 for each location in this State.
L.1961, c. 52, p. 529, s. 4. Amended by L.1962, c. 110, s. 1, eff. July 16, 1962; L.1983, c. 275, s. 4, eff. July 18, 1983.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-5 - Change of address; notice; fee

24:6B-5. Change of address; notice; fee
If any location of a registered business is to be changed, the registrant shall give the department written notice prior to the change of the address of such new location and the name and address of the individual to be in charge thereof. A fee of $20.00 shall accompany such notification.
L.1961, c. 52, p. 529, s. 5. Amended by L.1983, c. 275, s. 5, eff. July 18, 1983.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-6 - Cleanliness of premises

24:6B-6. Cleanliness of premises
Every room in the premises or place where drugs are manufactured, packaged or stored shall be kept clean and sanitary and shall be properly lighted, drained and ventilated. The walls and floors of such rooms shall be constructed of materials which can be properly cleaned and maintained. The operations carried on therein shall be conducted in a clean and sanitary manner so that the purity of the drugs therein manufactured, packaged or stored shall not be impaired.
L.1961, c. 52, p. 529, s. 6.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-7 - Cleanliness of equipment and machinery

24:6B-7. Cleanliness of equipment and machinery
Equipment and machinery used in the manufacture of drugs and any vehicles used for the transportation and delivery of such drugs shall be kept in a clean and sanitary condition.
L.1961, c. 52, p. 529, s. 7.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-8 - Washroom and toilet facilities

24:6B-8. Washroom and toilet facilities
Adequate washroom and toilet facilities shall be provided and maintained in the premise or place where drugs are manufactured, packaged or stored and such facilities shall be kept in a clean and sanitary condition.
L.1961, c. 52, p. 529, s. 8.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-9 - Adulteration or misbranding of drug; examination of records

24:6B-9. Adulteration or misbranding of drug; examination of records
Whenever an officer or employee of the department finds, or has probable cause to believe, that any drug is adulterated or misbranded, he shall have the right to examine and copy any records listing the ingredients used in the manufacture of such drug and the source of such ingredients and any records concerning the storage or shipment of such drug to determine whether the provisions of this act or of subtitle 1 of Title 24 of the Revised Statutes relating to adulteration or misbranding are being complied with.
L.1961, c. 52, p. 530, s. 10.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-10 - Order to correct violation

24:6B-10. Order to correct violation
If a registrant shall violate, directly or indirectly through his officers and employees, any of the provisions of this act, or any other provisions of subtitle 1 of Title 24 of the Revised Statutes, the commissioner may order the correction of the violation within such reasonable period of time as the commissioner may prescribe. Such an order shall be in writing, shall state the violation to be corrected, the period of time within which such violation shall be corrected and the individual or individuals who have actual administrative responsibility who shall be responsible for having such correction made. The order shall be delivered in person or by certified mail to an individual designated to receive service of the commissioner's orders.
If the commissioner's order is not complied with within the period specified therein, or within any extension thereof, the commissioner may order the registrant to stop engaging in such business or the part affected by the order until the order is complied with. If the registrant shall continue such business or part thereof after the commissioner has ordered the registrant to stop, any individual designated responsible in the commissioner's order for correcting the violation shall be a disorderly person.
Any registrant ordered by the commissioner to stop engaging in business or any part thereof may appeal from such order to the Superior Court. Pending a hearing and determination upon the appeal, the court may stay execution of all or part of the commissioner's order.
L.1961, c. 52, p. 530, s. 11.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-11 - Penalties.

24:6B-11 Penalties.
12. (a) Any person who does not comply with an order of the commissioner within the time specified shall be liable for the first offense for a penalty, to be established by the commissioner of not less than $200 nor more than $5,000 and for the second and each succeeding offense for a penalty of not less than $1,000 nor more than $20,000. The penalties herein provided shall be enforced by the department as plaintiff in a summary proceeding in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).
(b) Any person, who engages or continues to engage in the manufacturing or wholesaling of drugs without having registered with the department as required by this act is guilty of a disorderly persons offense.
L.1961,c.52,s.12;amended 1983, c.275, s.6; 2005, c.206, s.3.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-12 - Definitions.

24:6B-12 Definitions.
13. For the purposes of this registration act, unless otherwise required by the context:
(a) "Commissioner" means Commissioner of Health or the commissioner's designated representative.
(b) "Department" means the Department of Health.
(c) "Drugs" means "drugs" and "devices" as defined in R.S.24:1-1.
(d) "Person" means a natural person, partnership, corporation, or any other business association.
(e) "Registrant" means the person in whose name a drug manufacturing business or wholesale non-prescription drug business is registered.
(f) "Drug manufacturing business" means the business of creating, making, or producing drugs by compounding, growing, or other process. This definition shall apply to persons engaged in the drug manufacturing business who do not maintain a manufacturing location in this State but do operate distribution depots or warehouses of such business in this State. This definition shall not apply to licensed pharmacies or to licensed professional individuals such as, but not limited to, pharmacists, physicians, dentists, or veterinarians when engaged in the lawful pursuit of their professions.
(g) "Wholesale drug business" means the business of supplying non-prescription drugs to persons other than the ultimate consumer. This definition shall not apply to licensed pharmacies or to licensed professional individuals such as, but not limited to, pharmacists, physicians, dentists, or veterinarians when engaged in the lawful pursuit of their professions, and shall not apply to a registered drug manufacturing business.
L.1961, c.52, s.13; amended 2005, c.206, s.4; 2012, c.17, s.85.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-13 - Appropriation

24:6B-13. Appropriation
There is hereby appropriated to the department so much of the revenue, not in excess of $25,000.00, derived from the registration fees as shall be required to administer this act during the fiscal year ending June 30, 1962.
L.1961, c. 52, p. 532, s. 14.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-17 - Establishment, maintenance of list of authorized distributors.

24:6B-17 Establishment, maintenance of list of authorized distributors.
8. a. A manufacturer that is registered with the department pursuant to P.L.1961, c.52 (C.24:6B-1 et seq.) shall establish and maintain an up-to-date list of its authorized distributors and authorized distributors of record, as defined in section 5 of this act. The list shall be filed with the department, and each manufacturer shall publish the list on its website. The department shall provide electronic links to each manufacturer's website from the department's website. A manufacturer shall notify the department within 10 business days of any change to the list.
b. The commissioner may determine that a wholesale distributor is an authorized distributor if the wholesale distributor can demonstrate that it has a written agreement currently in effect with a manufacturer or a verifiable account with a manufacturer and meets the following transaction or volume requirement thresholds:
(1) 5,000 sales units per company within 12 months; or
(2) 12 purchases by invoice at the manufacturer's minimum purchasing requirement per invoice within 12 months.
L.2005,c.206,s.8.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-18 - Determination of eligibility for licensure renewal.

24:6B-18 Determination of eligibility for licensure renewal.
9. The department shall determine eligibility for licensure and renewal thereof, of persons engaged in the wholesale distribution of prescription drugs. In addition to any additional factors that the commissioner may deem relevant to protecting the public health and safety, the following shall be considered in determining an applicant's eligibility:
a. any suspension, sanction or revocation by a federal, state or local government of any license currently or previously held by the applicant or any of its owners for violations of laws regarding drugs;
b. the results of the applicant's criminal history record background check pursuant to section 7 of this act and information regarding the applicant's business provided pursuant to section 6 of this act;
c. the applicant's past experience in the manufacturing or distribution of drugs;
d. whether the applicant furnished false or fraudulent material in any application related to drug manufacturing or distribution;
e. compliance with previously granted licenses related to drug distribution or any health care professional or occupational licenses; and
f. a driver's license and Social Security number verification for all company officers, key management, principals and owners, provided that the review does not conflict with State confidentiality laws.
L.2005,c.206,s.9.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-19 - Additional requirements for designated representatives.

24:6B-19 Additional requirements for designated representatives.
10. In addition to satisfying any requirements that the commissioner may establish by regulation, a designated representative shall:
a. submit an application that includes the following information:
(1) the person's date and place of birth;
(2) the person's occupations, positions of employment and offices held during the past seven years, and the principal business addresses;
(3) whether the person has been temporarily or permanently enjoined by a court of competent jurisdiction during the past four years for violating any federal or state law regulating drugs, along with the details of those events;
(4) a description of any involvement by the person with any business that manufactured, administered, prescribed, distributed or stored prescription drugs and was named as a party in a lawsuit;
(5) a photograph of the person taken within the previous 30 days;
(6) the name, business address, occupation, date and place of birth for each member of the person's immediate family who is employed by the wholesale distributor in a management or operations position or has ownership in the wholesale distribution business. As used in this paragraph, the term "member of the person's immediate family" includes the person's spouse, children, parents and siblings, and the spouses of the person's children and the person's siblings; and
(7) such other information as the commissioner deems relevant.
b. have a minimum of two years of verifiable, full-time managerial, supervisory, auditing or compliance experience with: (1) a pharmacy, wholesale distributor or drug manufacturer licensed, permitted or registered in this or another state, territory of the United States or the District of Columbia; (2) a nationally recognized drug trade association; or (3) a state or federal agency, where the person's responsibilities included record keeping, storage and shipment of prescription drugs;
c. serve as the designated representative for only one wholesale distributor location at any one time; and
d. be actively involved in and aware of the actual daily operations of the wholesale distributor. As used in this subsection, "actively involved" means being: employed full-time in a managerial position; physically present at the facility during normal business hours; and knowledgeable about all policies and procedures pertaining to the wholesale distributor's operations. A designated representative may seek assistance from qualified individuals to help ensure compliance with the provisions of this subsection.
L.2005,c.206,s.10.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-20 - Requirements for facilities used for wholesale prescription drug distribution.

24:6B-20 Requirements for facilities used for wholesale prescription drug distribution.
11. All facilities used for wholesale prescription drug distribution shall:
a. be of suitable construction to ensure that all prescription drugs in the facilities are maintained in accordance with their labeling or official compendium standards;
b. be of suitable size and construction to facilitate cleaning, maintenance and proper wholesale distribution operations;
c. have adequate storage, lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions;
d. have a quarantine area for prescription drugs that are adulterated, counterfeit or suspected of being counterfeit, or otherwise unfit for distribution;
e. be maintained in a clean and orderly condition and free from infestation;
f. be secure from unauthorized entry, with the outside perimeter of the premises well-lighted and entry into areas where prescription drugs are held limited to authorized personnel;
g. be equipped with security and inventory management and control systems that provide suitable protection against theft, diversion or counterfeiting, and can readily provide data to the department; and
h. be a commercial location and not a personal dwelling or residence.
L.2005,c.206,s.11.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-21 - Provision of pedigree, certification prior to sale, return of prescription drug.

24:6B-21 Provision of pedigree, certification prior to sale, return of prescription drug.
12. a. Before the sale or return of a prescription drug to another wholesale distributor, a selling wholesale distributor shall provide a pedigree or a certification in accordance with the following specifications:
(1) if the seller is an authorized distributor of record, a pedigree for each prescription drug that is included on the specified list of susceptible products and was not purchased directly from the manufacturer; or
(2) if the seller is neither the prescription drug manufacturer nor an authorized distributor of record, a pedigree for each prescription drug that is distributed.
b. A wholesale distributor shall provide for the secure and confidential storage of information with restricted access and policies and procedures to protect the integrity and confidentiality of the information.
c. A wholesale distributor shall conduct business in a commercial location, and not a personal dwelling or residence.
d. A wholesale distributor shall provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting or diversion of prescription drugs.
L.2005,c.206,s.12.
2023 New Jersey Revised Statutes › Title 24 - Food and Drugs › Section 24:6B-22 - Annual report to the Legislature on tracking system.

24:6B-22 Annual report to the Legislature on tracking system.
13. The commissioner shall report annually to the Legislature on the availability of an effective standardized electronic product identification tracking system for prescription drugs in this State. The report shall address whether such a system can be feasibly implemented by manufacturers, wholesale distributors and pharmacies for purposes of authentication, and deterrence and detection of counterfeit drugs. If the commissioner determines that implementation of such a system is feasible, he shall make recommendations regarding the timing and method of implementing the system.
L.2005,c.206,s.13.