New Jersey Administrative Code

Each registrant shall comply with the return or recall provisions set forth in 21 CFR 1317.10, which is incorporated herein by reference. Notes N.J. Admin. Code § 13:45H-8.11 Adopted by 47 N.J.R. 2300(a), effective 9/8/2015

Every reverse distributor shall acquire controlled substances from a registrant as set forth in 21 CFR 1317.15, which is incorporated herein by reference. Notes N.J. Admin. Code § 13:45H-8.12 Adopted by 47 N.J.R. 2300(a), effective 9/8/2015

(a) Every registrant shall notify the Drug Control Unit within five days of the Drug Enforcement Administration authorizing the registrant to be an authorized collector of controlled substances as set forth in 21 CFR Part 1317 Subpart C. (b) Every registrant shall notify the Drug…

The listing of peyote as a controlled substance in schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the American Native Church so using peyote are exempt from registration. Any person who manufa…

(a) Authorized agents of incorporated humane societies or licensed animal care facilities registered to purchase, possess, and to dispense sodium pentobarbital for animal euthanasia pursuant to N.J.S.A. 24:21-11.f shall be authorized to dispense: 1. Any commercially prepared sodi…

Nothing in Parts 301 through 308, 311, 312, 316 of Federal Regulations shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions…

Notes N.J. Admin. Code § 13:45H-8.3 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

A practitioner who is registered to dispense controlled substances may distribute (without being registered to distribute) a quantity of such substance in accordance with 21 CFR 1307.11, which is incorporated herein by reference. Notes N.J. Admin. Code § 13:45H-8.4 Adopted by 47 …

As an incident to a distribution under N.J.A.C. 13:45H-8.4 a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the comp…

Notes N.J. Admin. Code § 13:45H-8.6 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

(a) Any registrant desiring to discontinue or transfer business activities altogether or with respect to controlled dangerous substances shall comply with the provisions of 21 CFR 1301.52, which is incorporated herein by reference. (b) A registrant shall notify the Drug Control U…

If acquired by and dispensed under the general supervision of a medical officer described in 21 CFR 1301.25(b), or the master or first officer of the vessel under the circumstances described in 21 CFR 1301.25(d), controlled substances may be held for stocking, be maintained in, a…

Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance as a result of the manufacture of a controlled substance or basic class of controlled substance for which he or she is registered and has been issued an individual manufacturing quo…

(a) The purpose of the rules in this subchapter is to establish, pursuant to N.J.S.A. 56:16-1 et seq., a bill of rights to protect the health, safety, and welfare of passengers of certain privately-owned autobuses operating over the public highways of the State for intrastate and…

The following words and terms, when used in this subchapter, shall have the following meanings unless the context indicates otherwise. "Autobus" means a privately-owned autobus for hire operated over the public highways in this State for the transportation of not more than 40 pas…

(a) An owner of an autobus shall take the following actions to protect the health, safety, and welfare of its passengers: 1. Ensure that all operators are well-trained; 2. Provide clear and conspicuous notice of customer complaint contact information as set forth in N.J.A.C. 13:4…

(a) The owner of an autobus shall display on the interior and exterior of the autobus, the customer complaint telephone number established by the Division for reporting violations of the autobus passenger bill of rights, using the following form of notice: FOR COMPLAINTS ABOUT TH…

(a) The Division shall maintain a telephone number specified in N.J.A.C. 13:45I-1.4(a), where customers may communicate complaints regarding the service provided by owners and operators of autobuses. (b) Upon receipt of a customer complaint, the director of the Division shall ini…

(a) A person who is determined to have violated the provisions of this subchapter shall be subject to a civil penalty of $ 1,000 for the first violation, $ 2,000 for the second violation, and $ 5,000 for third and subsequent violations. (b) Each day during which a violation occur…

(a) The rules in this chapter regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers to ensure that such relationships do not interfere with prescribers' independent professional judgment. The rules in this chapter do not apply t…

The provisions of this chapter shall not apply to contracts entered into on or before January 15, 2018. Notes N.J. Admin. Code § 13:45J-1.1A Adopted by 50 N.J.R. 578(a), effective 1/16/2018

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise: "Bona fide services" means those services provided by a prescriber pursuant to an arrangement formalized in a written agreement including, bu…

(a) A prescriber shall not accept, directly or indirectly, any financial benefit or benefit-in-kind, including, but not limited to, gifts, payments, stock, stock options, grants, scholarships, subsidies, and charitable contributions, except as permitted under N.J.A.C. 13:45J-1.4,…

(a) Consistent with the requirements of this chapter, a prescriber may accept the following from a pharmaceutical manufacturer or manufacturer's agent: 1. Items designed primarily for educational purposes for the patients or the prescriber that have minimal or no value to the pre…

A prescriber may accept sample medications that are intended to be used exclusively for the benefit of the prescriber's patients, provided the prescriber does not charge patients for such samples, and provided all dispensing standards, as applicable, set forth in the prescriber's…

A prescriber shall not accept more than $ 10,000 in the aggregate from all pharmaceutical manufacturers in any calendar year for the bona fide services of presentations as speakers at promotional activities, participation on advisory boards, and consulting arrangements. Payments …

A prescriber serving as a speaker at an education event or for a promotional activity shall directly disclose to attendees either orally or in writing at the beginning of the presentation that the prescriber has accepted payment for bona fide services from the sponsoring pharmace…

A prescriber who is an employee of a pharmaceutical manufacturer and who also provides patient care shall disclose to patients either orally or in writing his or her employment by the pharmaceutical manufacturer, but is exempt from the compensation prohibitions of this chapter. N…

The purpose of this chapter is to implement the provisions at P.L. 2023, c. 106 (N.J.S.A. 45:14-82.2 et seq.), which requires registration, notification, and reporting to the Division by reporting entities to make clear the major components of prescription drug pricing along the …

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. "Biological product" or "biologics" has the meaning of biological product as defined at 42 U.S.C. § 262(i)(1). "Biosimilar" means a drug th…

(a) Pursuant to the Data Collection Manual, a reporting entity shall register with the Division by January 31 of each calendar year and report any changes in registration information within 30 days. The Division may require such information and documentation as is necessary or us…

(a) A manufacturer shall notify the Division of price increases pursuant to N.J.S.A. 45:14-82.3.a within 10 days. Within 20 days of the price increase, the manufacturer shall report data required at N.J.S.A. 45:14-82.3.c and any other data requested by the Division to make clear …

(a) The Division shall notify a pharmacy benefits manager annually of the specific drugs or drug groups for which reporting is required. Within 60 days, the pharmacy benefits manager shall report to the Division the information at N.J.S.A. 45:14-82.4.a and any other data requeste…

(a) The Division shall notify a wholesaler annually of the specific drugs or drug groups for which reporting is required. Within 60 days, the wholesaler shall report to the Division the information at N.J.S.A. 45:14-82.5.a and any other data requested by the Division to make clea…

(a) A carrier that issues a health benefits plan with a prescription drug benefit shall report to the Division annually within 60 days of the close of each calendar year the information at N.J.S.A. 45:14-82.6.b and any other data requested by the Division to make clear the major …

(a) A pharmacy services administrative organization shall report to the Division annually within 60 days of the close of each calendar year the information at N.J.S.A. 45:14-82.7.a and any other data requested by the Division to make clear the major components of prescription dru…

In the event that State-specific data is unavailable to the manufacturer, other reporting entities shall comply within 60 days with a request from the Division for State-specific data for any drug or drug group on which a manufacturer reported pursuant to N.J.A.C. 13:45K-1.4(a) a…

In addition to the definitions set forth at N.J.S.A. 5:2A-1, the following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise: "Board" means the State Athletic Control Board. "Broadcast" means telecast, tel…

Announcers for combative sports in New Jersey may be designated by the promoters with the approval of the Commissioner and must be licensed by the Board. Notes N.J. Admin. Code § 13:46-10.1 Amended by R.1995, d.398, effective 7/17/1995. See: 27 New Jersey Register 1138(a), 27 New…

Announcers are forbidden to make any announcement whatsoever except as authorized to do so by the promoter with the consent of the Commission representative at the ringside. Notes N.J. Admin. Code § 13:46-10.2

After contestants and their chief seconds are in the ring, the boxing announcer shall announce the names of the contestants, their correct weights and other matters as may be directed by the Commissioner's representative. Notes N.J. Admin. Code § 13:46-10.3

Boxing announcers shall announce the referee's decisions at the end of contests and in the event of knockouts, the time of same and the round of occurrence. Notes N.J. Admin. Code § 13:46-10.4

(a) Announcers must not in any way by word or action attempt to show any partisanship inside or outside the ring. (b) They must remain seated in place and be silent except when making official announcements. Notes N.J. Admin. Code § 13:46-10.5

Boxing announcers must not at any time introduce from any ring any boxer or other person who is under suspension. Notes N.J. Admin. Code § 13:46-10.6

At the conclusion of a boxing bout, the announcer shall obtain the decision from the Commissioner or his representative and shall announce the decision from the ring. The manner of the announcement shall be directed by the Commissioner. Notes N.J. Admin. Code § 13:46-10.7 Amended…

Timekeepers for combative sports in New Jersey shall be appointed and licensed by the Commissioner. Timekeepers are at-will employees of the Board and, notwithstanding the procedure enumerated at N.J.A.C. 13:46-4.14, may have their licenses revoked or their renewal applications d…

(a) The compensation to timekeepers shall be paid by the promoter conducting the event and shall be $ 300.00. The Commissioner may increase the above compensation fee based upon consideration of the following factors: whether the regulated event includes a championship contest, n…