reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.1 - Frozen food locker plants

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The refrigeration
				system for a locker plant or branch locker storage plant shall be equipped with
				adequate and reliable automatic controls for the maintenance of uniform temperatures
				as required in the various rooms and shall be of adequate capacity to provide these
				temperatures under peak load conditions in the normal operation of the plant with
				extreme conditions of outside temperature.
(b) Each locker plant shall have thermometers so
				placed as to be readily accessible to public view in the various low temperature
				rooms.
(c) All food products offered for
				storage shall be placed in clean containers or wrappings suitable for freezing and
				proper storage, and clearly marked with the date of storage. Persons or firms
				operating locker or locker storage plants shall not place in a locker storage plant
				or allow to be received for processing, chilling, freezing, or storage in a locker
				or locker storage plant, any food articles in a state of decomposition or
				putrefaction, or in any other condition which renders them unfit for food, or in any
				condition which may cause deterioration in other food products.
(d) When articles of food, held in a locker plant,
				are removed from the packages in which they were contained and placed in other
				packages, the date of original entry into the locker plant of such articles shall be
				placed upon the containers into which they have been transferred; and if articles of
				food which have been placed in a locker or locker storage plant on different dates
				are packed in the same container, the date of storage of the article longest stored
				shall be placed upon the container to which such articles have been
				transferred.
(e) Any article of food, if
				intended for use other than human consumption shall be plainly and legibly labeled
				or marked with the words "Not for Human Consumption".
(f) All rooms in which food products are stored
				shall be provided with smooth, water-tight floors which can be readily cleansed.
				Floors must be kept in a clean condition at all times.
(g) The sidewalls and ceilings of all rooms shall
				be of smooth material, free from crevices and must be kept clean at all
				times.
(h) Waste materials shall not be
				permitted to accumulate in or around buildings in an insanitary manner. Waste
				materials shall be placed in clean metal containers.
(i) Adequate toilet facilities shall be provided
				for employees. All toilets shall be kept clean at all times.
(j) Adequate lavatory facilities shall be
				provided. All persons engaged in handling foods shall be required to wash hands
				before handling food after visiting toilet.
(k) No employer shall require, permit or allow any
				person to work in a cold storage warehouse, who is afflicted with any communicable
				disease.
(l) The license granted by the
				Department of Health to operate locker plant shall be displayed in the
				plant.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.2 - Sale of enriched white flour and unenriched white flour

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All flour, excepting
				that sold under a certificate as provided in
				24:11A-4, intended for sale for human
				consumption in New Jersey shall be held in containers which are marked in a plain
				and conspicuous manner with the words, "Enriched Flour" and with the name and
				address of the manufacturer, packer or distributor.
(b) All flour sold to distributors, bakers or
				other processors under the proviso contained in
				24:11A-4, which allows the sale of
				unenriched flour under certain conditions, shall be held in containers which are
				marked in a plain and conspicuous manner with the words, "Unenriched Flour", and the
				name and address of the manufacturer, packer or distributor.
(c) All persons purchasing flour which has not
				been enriched and which is to be resold or used as outlined in the proviso contained
				in 24:11A-4 shall furnish a certificate to
				the seller on the form adopted by the Board of Health of the State of New Jersey,
				and this certificate shall be kept on file by the seller for a period of two years.
				The purchaser shall keep a copy of each certificate for a period of two
				years.
(d) One certificate shall be
				furnished the seller by the purchaser covering all the flour purchased from him
				during the first half of the calendar year and one new certificate shall be
				furnished the seller by the purchaser for each following six-month period.
				Certificates issued during the first six months of the year shall expire on June 30
				and certificates issued during the last six months of the year shall expire on
				December 31.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.3 - Inspection reports

Current through Register Vol. 56, No. 14, July 15, 2024
A copy of the last inspection report shall be maintained by the
				  operator of each food establishment licensed under applicable provisions of Title 24
				  of the Revised Statutes and made available for inspection by a representative of the
				  Department of Health upon request.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.4 - Sale of ground meat and similar products

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following
				Federal standards of identity as currently promulgated and hereafter amended shall
				apply to the processing and retail sale of ground meat, sausage, and similar
				products in this State. The quality standards of
				9 CFR
				319.15,
				319.140,
				319.141,
				319.142,
				319.143,
				319.144,
				319.145,
				319.160,
				319.180,
				319.181,
				and
				319.182
				are incorporated herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.5 - Prohibition of sale of striped bass

Current through Register Vol. 56, No. 14, July 15, 2024
No person may expose for sale, offer for sale, or sell striped
				  bass (
Morone saxatilis
) in this State.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 2 - FOODS › Section 8:21-2.6 - Prohibition of sale of channel cat fish

Current through Register Vol. 56, No. 14, July 15, 2024
No person may expose for sale, or sell channel catfish
				  (
Ictalurus punctatus
) harvested from the Delaware River between the
				  Interstate 276 Highway Bridge in Burlington Township, Burlington County and Birch
				  Creek, which flows into the Delaware River at Logan Township, Gloucester
				  County.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.1 - Warning statements for drug labels

Current through Register Vol. 56, No. 14, July 15, 2024
The warning statements for drug label requirements under
				  21 CFR
				  369.20 are incorporated by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.2 - Rulings on dangerous cosmetics

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The toxic effect of
				paraphenylenediamine is well known. A number of persons have suffered severe injury,
				and in some cases blindness has resulted from the application of this dye to the
				eyelashes and eyebrows. There is no doubt that preparations containing this dye are
				in violation of the Food, Drug and Cosmetic Act. The Department of Health of the
				State of New Jersey has obtained very definite evidence of injury from this dye.
				Based upon a serious consideration of the injurious effects of paraphenylenediamine,
				eyelash and eyebrow dyes containing paraphenylenediamine in any amount will be
				considered adulterated under
				24:5-11.1(a)  and
				appropriate action taken. It has also been noted that substances such as oils,
				argyrol, magnesium carbonate, paper shields, and the like are customarily included
				in packages of eyelash and eyebrow dye preparations to be used to prevent the
				introduction of the dye into the eyes. It is the opinion of the Department that the
				use of these precautionary measures cannot guarantee protection of the eyes against
				such dangerous product as paraphenylenediamine. This notice should not be
				interpreted as indicating that other dyes used for eyelash and eyebrow dyeing are to
				be accepted as meeting the requirements of
				24:5-11.1(a).
(b) The toxic effect of paratoluylenediamine is
				well known. There is no doubt that preparations containing this dye are in violation
				of the Food, Drug, and Cosmetic Act. Based upon a serious consideration of the
				injurious effects of paratoluylenediamine, eyelash and eyebrow dyes containing
				paratoluylenediamine in any amount will be considered adulterated pursuant to
				N.J.S.A. 24:5-11.1(a)
				 and appropriate action taken. It has also been
				noted that substances such as oils, argyrol, magnesium carbonate, paper shields, and
				the like are customarily included in packages of eyelash and eyebrow dye
				preparations to be used to prevent the introduction of the dye into the eyes. It is
				the opinion of the Department of Health that the use of these precautionary measures
				cannot guarantee protection of the eyes against such dangerous product as
				paratoluylenediamine. This notice should not be interpreted as indicating that other
				dyes used for eyelash and eyebrow dyeing are to be accepted as meeting the
				requirements at
				N.J.S.A.
				24:5-11.1(a).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.3 - Keeping of records by drug manufacturing businesses and wholesale drug businesses

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Drug manufacturing
				businesses shall maintain records identifying the source of each ingredient used in
				the manufacture or processing of a drug. Records identifying the source of each
				ingredient shall include the date of receipt of the ingredient, vendor's name and
				address, the name of the ingredient and the vendor's batch number, lot number,
				control number or other identifying symbol, if any, used by the vendor to identify
				the ingredient as well as the grade (such as U.S.P., N.F., reagent, technical or
				crude) and quantity of said ingredient.
(b) Drug manufacturing businesses shall maintain a
				system of record keeping that will permit the identification for purposes of recall
				of any lot or batch of a drug from the market when such is found to be unsafe for
				use. As part of this system, the manufacturer shall insure that the container of any
				drug at any stage in the process of manufacture and distribution bears an
				identifying name and number, commonly known as "lot" or "control" number, to make it
				possible to determine the complete manufacturing history of the package of the drug.
				This Section shall not require that the manufacturer keep a record of the control
				number of any given shipment of drugs if the manufacturer's overall records are such
				as to enable the manufacturer to recall an unsafe drug.
(c) Wholesale drug businesses shall maintain
				records identifying each drug received. Records of receipt shall include the date
				the drug was received, the vendor's name and address, the drug name and the quantity
				of the drug received. Such records in the form of vendors' invoices shall suffice
				for compliance with this regulation.
(d)
				Wholesale drug businesses shall maintain records of shipments which identify the
				recipient of the drug by name, street address, city and state, date of shipment, the
				drug name and the quantity of the drug shipped. Such records in the form of
				customers' invoices shall suffice for compliance with this regulation.
(e) Records required by this Section shall be
				maintained for not less than 24 consecutive months.
(f) The provisions of this section shall not apply
				to "commercial feeding stuff" as these articles are defined and administered under
				the provisions of N.J.S.A. 4:4-1 et seq.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.4 - Paregoric

Current through Register Vol. 56, No. 14, July 15, 2024
Paregoric, as defined in the United States Pharmacopoeia XVII,
				  shall be henceforth regarded as a narcotic drug and subject to the provisions of the
				  Controlled Dangerous Substances Act,
				  24:21-1 et seq., of this State
				  requiring a prescription except when sold or dispensed in compounds containing not
				  more than one fluid drachm of Paregoric in each fluid ounce.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.5 - Compressed air used in self contained underwater breathing apparatus (SCUBA)

Current through Register Vol. 56, No. 14, July 15, 2024
Components of compressed air shall not exceed the following
				  limits:
CARBON MONOXIDE
10 parts/million (PPM) 0.001%
CARBON DIOXIDE
1000 PPM 0.1%
OIL
0.02 mg/liter
WATER
Saturation
ODOR
Free from objectionable odors
OTHER
Contaminants deleterious to health
shall not be present
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.6 - SCUBA recommendations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The recommendations in this section are
				primarily directed to purveyors of SCUBA air to protect public health.
(b) Compressed air containers. No compressed air
				container used for self-contained underwater breathing apparatus should be filled or
				refilled unless it shows evidence of a recent I.C.C. hydrostatic test.
(c) Preparation of compressed air. Uncontaminated
				air may be compressed by means of suitable equipment and the compressed air should
				not exceed the limits set forth in this section. The following sampling, testing,
				and test procedures may be used to determine the quantitative composition of the
				compressed air.
1. Carbon monoxide. Determination
				of carbon monoxide may be made by using:
i. Mine
				Safety Appliance Detector Co., Carbon Monoxide Tester No. Ds-47133;
ii.  U.S. Safety Services Detector, model 300
				"Saf-Co-Meter";
iii. Kitagawa Precision
				Gas Detection Unico Model No. 400, with the cartridge No. 106A; or its
				equivalents;
iv. Any other device or
				method acceptable to the Department of Health.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.7 - Animal repellants

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The list of animal
				repellants which are non-injurious to canines or other animals and which immobilize
				only temporarily and produce only temporary physical discomfort covered by the
				exemptions pursuant to the provisions of
				2C:39-6(h)  shall
				include, but not be limited to, the following trade products:
1. Dog Chaser;
2. Guardian;
3. Halt;
4. Sentinel;
5. Stinger;
6. Stop Dog.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.8 - List of ingredients for human self-defense sprays

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following list
				of active and inactive ingredients can be used in devices which contain and release
				chemical substances which cause temporary physical discomfort covered by the
				exemptions pursuant to the provisions of
				2C:39-6(i):
1. Active ingredients:
i. Chloroacetophenone
ii. Ortho-chlorobenzalmalonitrile
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3 - DRUGS, DEVICES AND COSMETICS › Section 8:21-3.9 - Permit for nitrous oxide

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every person or firm desiring to use or
				distribute nitrous oxide, except a duly licensed physician, dentist, veterinarian,
				nurse, hospital, sanitarium, or other medical institution, or a resident physician
				or intern of a hospital, sanitarium, or medical institution, and those buying or
				selling nitrous oxide for use in food preparation equipment or registered pursuant
				to N.J.S.A. 24:6G-1etseq., shall complete a permit application provided by the
				Department and provide the following information:
1. The name of the person or firm requesting the
				permit;
2. The address of the person or
				firm;
3. The telephone number of person
				or firm;
4. If the applicant is a
				natural person, a photocopy of proof of the applicant's age, such as a copy of a
				current driver license, recent passport, birth certificate or other identification
				that includes the date of birth of the applicant (original documentation shall not
				be submitted);
5. If the applicant is a
				non-publicly held non-natural person, a photocopy of proof of the applicant's
				owners' ages, such as a copy of a current driver license, recent passport, birth
				certificate or other identification that includes the date of birth of the
				applicant's owners (original documentation shall not be submitted);
6. The location at which the nitrous oxide is to
				be used;
7. The signature of person in
				charge of the location where the nitrous oxide is to be used;
8. The purpose for such use;
9. The name and address of the distributor from
				whom the nitrous oxide is to be obtained; and
10. Any other information as may be requested by
				the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.1 - Scope

Current through Register Vol. 56, No. 14, July 15, 2024
This subchapter sets forth standards for the registration and
				  operation of any person, partnership, corporation or business firm engaging in the
				  wholesale distribution of drugs.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.2 - Purpose

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of this
				subchapter is to:
1. Implement the requirements of
				the Federal Prescription Drug Marketing Act of 1987,
				21 U.S.C. §
											351,
				353,
				371 and
				374, and
				21
				CFR 205 for the benefit of the health and safety of the ultimate consumers of
				prescription drugs;
2. Implement, as
				appropriate in New Jersey, the National Association of Boards of Pharmacy's "Model
				Rules for the Licensure of Wholesale Distributors (March 18, 2005)," available by
				written request to National Association of Boards of Pharmacy, 1600 Feehanville
				Drive, Mount Prospect, Illinois 60056, telephone (847) 391-4406, for the benefit of
				the health and safety of the ultimate consumers of drugs; and
3. Establish standards for the wholesale
				distribution of OTC and non-prescription drugs for the benefit of the health and
				safety of the ultimate consumers of OTC and non-prescription drugs.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.4 - Application requirements; reciprocity

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department may
				permit an out-of-State wholesale distributor to satisfy the registration
				requirements of this subchapter on the basis of reciprocity provided that such
				out-of-State wholesale distributor possesses a valid license or registration granted
				by another state pursuant to legal standards comparable to those which must be met
				by a registrant of this State as prerequisites for satisfying the registration
				requirements under the laws of this State.
(b) Every wholesale distributor of drugs shall
				apply to the Department in accordance with the provisions of
				24:6B-2 using forms supplied by the
				Department. In addition, every applicant shall complete the appropriate sections of
				the application, which shall include:
1. Name,
				full business address and telephone number of the applicant;
i. All trade or business names used by the
				registrant;
ii. Addresses, telephone
				numbers and name of the contact person for all facilities used by the registrant for
				the storage, handling and distribution of drugs;
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.5 - Evaluation criteria

Current through Register Vol. 56, No. 14, July 15, 2024
(a) In considering any
				application for registration, the Department shall consider, at a minimum, the
				following factors in reviewing the qualifications of those persons applying for
				registration as a wholesale drug distributor:
1.
				Any convictions of the applicant under any Federal, state, or local laws relating to
				drug samples, wholesale or retail drug distribution, or distribution of a controlled
				substance;
2. Any felony conviction
				under Federal laws, or the equivalent (under whatever statutory term) conviction
				under state or local laws;
3. The
				applicant's past experience in the manufacturing or distribution of drugs or
				controlled substances;
4. The furnishing
				of false or fraudulent material in any application made in connection with drug or
				device manufacturing or distribution;
5.
				Suspension or revocation by Federal, state or local government of any registration
				currently or previously held by the applicant for the manufacture or distribution of
				any drugs, including controlled substances;
6. Compliance with license and/or registration
				requirements under any previously granted license or registration, if any;
7. Compliance with requirements to maintain and/or
				make available to the Department or Federal or local law enforcement officials those
				records required by this subchapter; and
8. Any other factors or qualifications the
				Department considers relevant to and consistent with the public health and
				safety.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.6 - Denial of application

Current through Register Vol. 56, No. 14, July 15, 2024
The Department shall have the right to deny an application for
				  registration if it determines the granting of such registration would not be in the
				  public interest or for submitting false information on an application. Public
				  interest considerations shall be based upon factors and qualifications that are
				  directly related to the protection of the public health and safety as delineated in
				  8:21-3A.5.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.7 - Personnel requirements

Current through Register Vol. 56, No. 14, July 15, 2024
Personnel employed by a wholesale distributor shall have
				  appropriate education and/or experience to assume responsibility for positions that
				  would affect compliance with registration requirements.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.8 - Facility

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All facilities at
				which drugs are stored, warehoused, handled, held, offered, marketed, or displayed
				shall:
1. Be of suitable size and construction to
				facilitate cleaning, maintenance, and proper operations;
2. Provide storage areas which include adequate
				lighting, ventilation, temperature, sanitation, humidity, space, equipment, and
				security conditions;
3. Provide a
				quarantine area for storage of outdated, damaged, deteriorated, misbranded or
				adulterated drugs, or drugs that are in immediate or sealed secondary containers
				that have been opened;
4. Be maintained
				in a clean and orderly condition; and
5.
				Be free from infestation by insects, rodents, birds, or vermin of any
				kind.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.9 - Security

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All facilities used
				for wholesale distribution shall be secure from unauthorized entry and shall provide
				the following additional security measures:
1.
				Access from outside the premises shall be kept at a minimum and shall be well
				controlled;
2. The outside perimeter of
				the premises shall be well-lighted; and
3. Entry into areas where prescription drugs are
				held shall be limited to authorized personnel.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.10 - Storage

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All drugs shall be stored at appropriate
				temperature and conditions, in accordance with the requirements set forth in the
				labeling of such drugs or with the requirements of the current edition of an
				official compendium, such as the United States Pharmacopeia/National Formulary
				(USP/NF).
(b) If no storage requirements
				are established for a prescription drug, the drug may be held at controlled room
				temperature, as defined in an official compendium, to help ensure that its identity,
				strength, quality, and purity are not adversely affected.
(c) Appropriate manual, electromechanical or
				electronic temperature and humidity recording equipment, devices and/or logs shall
				be utilized to document proper storage of drugs.
(d) For prescription drugs, a record must be
				maintained recording the date; time; thermometer temperature; and the initials of
				the person recording the data or reviewing the data if electronically monitored.
				This record and temperature reading must be recorded at least five days each week
				with the temperature readings taken between 1:00 P.M. and 5:00 P.M. E.S.T. Alternate
				times may be approved by the Department in writing. This record must be kept on file
				by the facility for at least two years.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.11 - Examination of materials

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Upon receipt, each
				outside shipping container shall be visually examined for identity and to prevent
				the acceptance of counterfeit, misbranded, contraband or contaminated prescription
				drugs or prescription drugs that are otherwise unfit for distribution, and such
				examination shall be adequate to reveal container damage that would suggest possible
				contamination or other damage to the contents. If visual examination of the shipping
				container or other conditions surrounding the transaction suggest possible
				counterfeiting or contamination, the person has a duty to examine further the
				contents or conditions of sale.
(b) Each
				outgoing shipment of prescription drugs shall be carefully examined for the identity
				of the prescription drug products and to ensure that there is no delivery of
				prescription drugs that have been damaged in storage or held under improper
				conditions.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.12 - Returned, damaged and outdated prescription drugs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Prescription drugs
				that are outdated, damaged, deteriorated, misbranded, or adulterated shall be
				quarantined and physically separated from other prescription drugs until they are
				destroyed or returned to their supplier.
(b) Prescription drugs whose immediate or sealed
				outer or sealed secondary containers have been opened or used shall be identified as
				such, and shall be quarantined and physically separated from other prescription
				drugs until they are either destroyed or returned to the supplier.
(c) If the conditions under which a prescription
				drug has been returned cast doubt on the drug's safety, identity, strength, quality
				or purity, then the drug shall be destroyed or returned to the supplier, unless
				examination, testing or other investigation proves the drug meets appropriate
				standards of safety, identity, strength, quality and purity. The wholesale
				distributor of prescription drugs shall consider, among other things, the conditions
				under which the drugs were held, stored, or shipped before or during their return
				and the condition of the drug and its container, carton, or labeling as a result of
				storage and shipping when considering that there is any doubt of the drug's safety,
				identity, strength, quality or purity.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.13 - Recordkeeping

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Wholesale
				distributors of prescription drugs shall establish and maintain inventories and
				records of all transactions regarding the receipt and distribution or other
				disposition of prescription drugs. Records shall include the following information:
1. The source of the prescription drugs, including
				the name and principal address of the seller or transferor, and the address of the
				location from which the prescription drugs were shipped;
2. The identity and quantity of the prescription
				drugs received and distributed or disposed of;
3. The dates of receipt and distribution or other
				disposition of the prescription drugs;
4. Invoices that shall reflect the amount billed
				per prescription drug product; and
5.
				Inventory: A complete and accurate record of all stock of prescription drugs on hand
				must be made annually by wholesale distributors.
i. A physical inventory of prescription drugs must
				be conducted at least annually unless perpetual inventory records are maintained, in
				which case the physical inventory may be conducted on a biennial basis.
ii. If a wholesale distributor does not maintain a
				perpetual inventory, the annual physical inventory shall be retained for a period of
				three years following their creation date.
iii. Significant inventory discrepancies shall be
				investigated, and handled in accordance with written policies and
				procedures;
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.14 - Due diligence

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Prior to the initial
				purchase or acquisition of prescription drugs from another wholesale distributor, a
				wholesale distributor shall obtain the following information from the selling
				wholesale distributor:
1. Copies of all state and
				Federal regulatory licenses and registrations;
2. The wholesaler distributor's most recent
				facility inspection reports;
3. A list
				of other names under which the wholesale distributor is doing business or by which
				the wholesale distributor was formally known;
4. A list of corporate officers and managerial
				employees and designated representative; and
5. A verification of the selling wholesale
				distributor's status as an authorized distributor of record, if
				applicable.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.15 - Availability of records and inventories

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Records and
				inventories, including those related to any prescription drug salvage or
				reprocessing procedure, shall be made readily available and readily retrievable for
				inspection and photocopying by Federal, State or local law enforcement agencies
				shall be maintained for a period of three years following the disposition of the
				drugs.
(b) The records that are kept at
				the inspection site or that can be immediately retrieved by computer or other
				electronic means shall be readily available for authorized inspection during the
				retention period, and records kept at a central location apart from the inspection
				site and not electronically retrievable shall be made available for inspection
				within two working days of a request by an authorized official of a Federal, state
				or local enforcement agency.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.16 - Policies and procedures

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Wholesale
				prescription drug distributors shall establish, maintain, and adhere to written
				policies and procedures which shall be followed for the receipt, security, storage,
				inventory, and distribution of prescription drugs, including policies and procedures
				for identifying, recording, and reporting losses or thefts, and for correcting all
				errors and inaccuracies in inventory. Wholesale drug distributors shall include in
				their policy and procedures the following:
1. A
				procedure whereby the oldest approved stock of a prescription drug is distributed
				first. The procedure may permit deviation from this requirement if the deviation is
				temporary and appropriate;
2. A
				procedure to be followed for, and which shall be adequate for, handling recalls and
				withdrawals due to:
i. Any action initiated by the
				request of the Food and Drug Administration or other Federal, state, local law
				enforcement or other government agency, including the State registering
				agency;
ii. Any voluntary action by the
				manufacturer to remove defective or potentially defective drugs from the market;
				or
iii. Any action undertaken to promote
				public health, and safety by replacing existing merchandise with an approved product
				or new package design.
3. A
				procedure to ensure that a wholesale distributor prepares for, protects against, and
				handles any crisis that affects security or the operation of any facility in the
				event of strike, fire, flood, or other natural disaster, or other situations of a
				local, State or national emergency; and
4. A procedure to ensure that outdated
				prescription drugs shall be segregated from other drugs and either returned to the
				manufacturer or destroyed. Such procedure shall provide for written documentation of
				the disposition of the outdated prescription drugs and shall be maintained for three
				years after disposition of the outdated prescription drugs.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.17 - List of responsible persons

Current through Register Vol. 56, No. 14, July 15, 2024
Wholesale drug distributors shall maintain a list of officers,
				  directors, managers, designated representative and other persons in charge of
				  wholesale distribution, storage, and handling of prescription drugs that include a
				  description of their duties and a summary of their qualifications.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.18 - Inspection and auditing

Current through Register Vol. 56, No. 14, July 15, 2024
Wholesale drug distributors shall permit the Department and
				  authorized Federal, State and local law enforcement officials to enter and inspect
				  their premises and delivery vehicles, and to audit their records and written
				  operating procedures, at reasonable times and in a reasonable manner, to the extent
				  authorized by law.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.19 - Salvage; reprocessing

Current through Register Vol. 56, No. 14, July 15, 2024
Wholesale drug distributors shall be subject to the provisions of
				  any applicable Federal, State or local laws, rules or regulations that relate to
				  drug product salvaging or reprocessing.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.20 - Suspension; revocation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				suspend or revoke any registration granted under this subchapter upon adjudication
				of civil liability or criminal conviction of the registrant of a violation of
				applicable Federal, State or local drug laws, rules or regulations.
(b) The Department may suspend or revoke any
				registration granted hereunder for any violation of this chapter, submitting false
				information on an initial or renewal application, falsification of records, or any
				good cause within the meaning and purpose of the law.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.21 - Penalties

Current through Register Vol. 56, No. 14, July 15, 2024
The Department may provide for fines, imprisonment, or civil
				  penalties as set forth in
				  24:6B-11 or 24:17.1.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.22 - Appeals

Current through Register Vol. 56, No. 14, July 15, 2024
Prior to the suspension or revocation of a registration issued in
				  accordance with this subchapter, the registrant shall have a right to prior notice
				  and a hearing pursuant to the Administrative Procedure Act,
				  52:14B-1 et seq., and the Uniform
				  Administrative Procedure Rules N.J.A.C. 1:1.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 4 - NEW DRUGS › Section 8:21-4.1 - Statement of policy

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following "new drug" regulations as
				adopted by the Department of Health (Department) are to provide guidance in the
				administration of the provisions of N.J.S.A. 24:6A-1 et seq.
(b) To ensure that a complete and comprehensive
				review for safety is provided to a new drug application submitted pursuant to the
				State act, it has been deemed proper and expeditious to adopt by reference such
				procedures, records, reports, sampling, toxicology, pathology, and clinical testing
				measures afforded to new drugs by the United States Food and Drug Administration as
				provided in 21 C.F.R. 300, 310, 312, and 314.
(c) It is the intent and policy of the Department
				to implement and administer those provisions of the Federal new drug regulations
				adopted by this Department that pertain to or are concerned with the safety of the
				product subject of a State new drug application.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 4 - NEW DRUGS › Section 8:21-4.2 - Combination drugs

Current through Register Vol. 56, No. 14, July 15, 2024
21 C.F.R.
				  300.50, Fixed combinations prescription drugs for
				  humans, is hereby adopted by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 4 - NEW DRUGS › Section 8:21-4.3 - General provisions; definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(a)
									21 C.F.R.
				310.3 (Definitions and interpretations),
				21 C.F.R.
				310.4 (Biologics, products subject to license
				control) and 21 C.F.R. 310.9 (Designated journals) are hereby adopted by reference,
				with the following modifications.
(b)
				The definitions set forth in subpart A (General provisions), section
				21 CFR
				310.3 pursuant to the intent and policy of the
				Department as set forth in a preamble to new drug regulations, mean the following:
1. The term "act" means the Title 24, New Jersey
				Statutes Annotated.
2. The term
				"department" means the New Jersey Department of Health (Department).
3. The term "secretary" means the New Jersey
				Commissioner of Health.
4. Where
				administrative procedures are set forth in the Federal regulations, the provisions
				of 52:14B-1 et seq. shall apply.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 4 - NEW DRUGS › Section 8:21-4.4 - Exemptions from section 505(a)

Current through Register Vol. 56, No. 14, July 15, 2024
(a)
									21 C.F.R.
				312.1 (Conditions for exemption of new drugs for
				investigational use), 21 C.F.R. 312.5 (Confidentiality of data and information in an
				investigational new drug notice, IND), and 21 C.F.R. 312.9 (New drugs for
				investigational use in laboratory research animals or in vitro tests) are hereby
				adopted by reference.
(b) Regarding
				subpart B (Controlled substances),
				21 C.F.R.
				312.10, Availability of records, is hereby adopted
				by reference.
(c) Regarding subpart C
				(International research),
				21 C.F.R.
				312.20, Clinical data generated outside the United
				States and not subject to a "Notice of Claimed Investigational Exemption of a New
				Drug", is hereby adopted by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 4 - NEW DRUGS › Section 8:21-4.5 - General provisions; new drug applications

Current through Register Vol. 56, No. 14, July 15, 2024
(a)
									21
				C.F.R. 314.1(Applications),
				21
				C.F.R. 314.60 (Amended applications),
				21 C.F.R.
				314.65 (Withdrawal of applications without
				prejudice),
				21 C.F.R.
				314.70 (Supplemental applications),
				21 C.F.R.
				314.90 (Insufficient information in application),
				21 C.F.R.
				314.105 (New drug application approvals;
				notification to applicant of approval of application; availability of information),
				21
				C.F.R. 314.420 (Master files), 21 C.F.R. 314.12
				(Untrue statements in application),
				21 C.F.R.
				314.104 (New drugs with potential for abuse) and
				21 C.F.R. 314.140 (Confidentiality of data and information in a new drug
				application, NDA, file) are hereby adopted by reference.
(b) Subpart B (Administrative actions on
				applications),
				21 C.F.R.
				314.102 (Comment on application),
				21 C.F.R.
				314.125 (Reasons for refusing to file
				applications),
				21 C.F.R.
				314.125 (Reasons for refusing to file
				applications), 21 C.F.R. 314.120 (Refusal to approve the application),
				21
				C.F.R. 314.150 (Withdrawal of approval of an
				application),
				21
				C.F.R. 314.152 (Notice of withdrawal of approval
				of application),
				21
				C.F.R. 314.160 (Revocation of order refusing to
				approve application, or suspending or withdrawing approval of an application), and
				21 C.F.R.
				314.162 (Notices and orders) are hereby adopted by
				reference.
(c) Full text of Federal
				regulations pertaining to new drugs, incorporated herein by reference, may be found
				at sections 310, 312 and 314 of 21 C.F.R., parts 300 through 499, revised as of
				April 11, 1989 and may be purchased from:
Superintendent of Documents
United States Government Printing Office
Washington, D.C. 20402
(d) The complete text of those sections adopted by
				the Department may be reviewed in the:
New Jersey Department of Health and Senior Services
Consumer and Environmental Health Services
PO Box 369
Trenton, New Jersey 08625-0369
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 5 - MANUFACTURING, STORAGE, DISTRIBUTION, AND HANDLING STANDARDS FOR BOTTLED WATER › Section 8:21-5.1 - Separability

Current through Register Vol. 56, No. 14, July 15, 2024
If any provision or application of any provision of this
				  subchapter is held invalid, that invalidity shall not affect other provisions or
				  applications of this subchapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 5 - MANUFACTURING, STORAGE, DISTRIBUTION, AND HANDLING STANDARDS FOR BOTTLED WATER › Section 8:21-5.3 - Water source protection

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The source water
				supply for bottled water shall be from an approved source which is properly located,
				protected, and operated and shall be easily accessible, adequate, and of safe,
				sanitary quality. The water quality and sampling frequency shall be in conformance
				at all times with the applicable laws and rules and regulations of the Department or
				other governmental agencies having jurisdiction. Examples of source water supplies
				which may be used for bottled water upon approval by the Department are as follows:
1. Approved public community water
				systems;
2. Drilled and driven wells
				when constructed and protected in accordance with applicable standards set forth in
				N.J.A.C. 7:10-12, Standards for the Construction of Public Non-community and
				Non-public Water Systems; and
3. Springs
				inspected for development as a water source and constructed in accordance with the
				applicable standards established by the Department of Environmental Protection and
				set forth in 7:10-12.24, Standards for the
				Construction of Public Non-Community and Non-Public Water Systems (springs) and
				shall meet the standards for springs set forth under
				8:21-5.4.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 5 - MANUFACTURING, STORAGE, DISTRIBUTION, AND HANDLING STANDARDS FOR BOTTLED WATER › Section 8:21-5.4 - Springs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The spring shall be
				properly protected from the entry of insects, birds, rodents and other
				vermin.
(b) Adequate ventilation shall
				be provided.
(c) Sufficient protection
				shall be provided at the intake end of the draw pipe to prevent the introduction of
				stone, gravel, sand and other particulate matter.
(d) The overflow shall be free-flowing and shall
				be constructed in a manner to prevent flooding of the springhouse and surrounding
				area.
(e) The minimum distance from a
				spring to a building sewer line, septic tank, and a distribution box shall be 50
				feet. The minimum distance from a spring to a disposal field or seepage pit shall be
				100 feet.
(f) Plumbing shall be sized,
				installed and maintained in accordance with applicable State and local standards.
				Also, plumbing shall be properly designed and protected from contamination and
				damage.
(g) Walls and ceilings shall be
				smooth, easily cleanable, free of cracks and crevices and constructed of materials
				that are not adversely affected by moisture, algae, or mold.
(h) Proper cleaning and sanitization equipment and
				facilities shall be available and used whenever a spring is damaged, repaired and/or
				contaminated.