N.J. Admin. Code § 13:45A-27.7

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:45A-27.7 - Manufacture and distribution by approved vendors; withdrawal or termination from NJPB program

(a) NJPBs shall be manufactured and distributed by vendors approved by the Division pursuant to N.J.A.C. 13:45A-27.6. A vendor who has failed to comply with the requirements of this subchapter or the NJPB program contract specifications shall not be approved for the manufacture or distribution of NJPBs.

(b) A vendor may withdraw from the NJPB program upon 14 days written notice to the Division. A vendor that voluntarily withdraws from the program shall notify, in writing, at least 30 days prior to withdrawal, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months.

(c) A vendor's approval to participate in the NJPB program may be terminated by the Division upon 14 days written notice for any failure to comply with the requirements as set forth in this subchapter or the NJPB program specifications. The Division shall provide the vendor with the opportunity to respond in writing to any allegation of a failure to comply with NJPB program requirements. A vendor whose approval to participate in the NJPB program is terminated by the Division shall notify, in writing, within seven days of such termination, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months.

(d) A vendor that voluntarily withdraws from the NJPB program or is terminated by the Division shall either destroy or forward all materials, computer disks, plates, mechanicals, negatives, and other equipment related to the production or distribution of NJPBs to another approved vendor or the Division within seven days of notice of withdrawal or termination. If the vendor that withdraws or is terminated from the NJPB program does not forward all materials related to the production and distribution of NJPBs to the Division, the vendor shall provide to the Division a certification verifying the destruction or disposition of such materials.

(e) A vendor that voluntarily withdraws from the program or is terminated by the Division shall submit to the Division a list of all licensed prescribers and healthcare facilities that ordered NJPB pads from the vendor within the previous six months. The list shall be submitted within seven days of notice of withdrawal or termination and shall include all the information that is required to be maintained in the vendor database pursuant to N.J.A.C. 13:45A-27.9(h).

(f) Any person manufacturing or distributing NJPBs without approval by the Division shall be subject to prosecution for theft and/or forgery by appropriate criminal authorities pursuant to N.J.S.A. 2C:20-2 and 2C:21-1 et seq.

(g) Any person manufacturing or distributing NJPBs without approval by the Division shall be subject to an action to cease and desist, and any other action authorized by law.

N.J. Admin. Code § 13:45A-27.7

Amended by R.2010 d.043, effective 2/16/2010.
See: 41 N.J.R. 2624(a), 42 N.J.R. 592(a).
In (c), substituted "A vendor's approval to participate in the NJPB program" for "An approved vendor", "failure" for "inability", "a failure" for "an inability" and "whose approval to participate in the NJPB program" for "that".