N.J. Admin. Code § 13:45H-2.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:45H-2.4 - Other security controls for nonpractitioners

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry with the Drug Control Unit to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to disclose suspicious orders of controlled substances. The registrant shall inform the Drug Control Unit of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify the Drug Control Unit of any theft or loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to (e) below upon discovery of such theft or loss. The registrant shall also complete DDC-52 form regarding such theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) The registrant shall not distribute any controlled substance listed in Schedules II through V as a complimentary sample to any potential or current customer without the prior written request of the customer, to be used only for satisfying the legitimate medical needs of patients of the customer, and only in reasonable quantities. Such request must contain the name, address and registration number of the customer and the name and quantity of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of N.J.A.C. 13:45H-6 shall be complied with for any distribution of a controlled substance listed in Schedule II. For purposes of this paragraph, the term "customer" includes a registrant to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance by the registrant.

(e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in 13:45H-2.2. In addition, the registrant shall employ precautions (for example assuring that shipping containers do not indicate that contents are controlled substances) to guard against storage or in-transit losses.

(f) When distributing controlled substances through agents (for example, detailmen), a registrant is responsible for providing and requiring adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.

(g) Before the initial distribution of carfentanil, etorphine hydrochloride, and/or diprenorphine to any person, the registrant must verify that the person is authorized to handle the substance(s) by contacting the Drug Enforcement Administration.

N.J. Admin. Code § 13:45H-2.4

As amended, R.1974 d.261, effective 9/20/1974.
See: 6 N.J.R. 309(b), 6 N.J.R. 397(c).
As amended, R.1979 d.70, effective 2/15/1979.
See: 11 N.J.R. 12(a), 11 N.J.R. 130(b).
As amended, R.1984 d.529, effective 11/19/1984.
See: 16 N.J.R. 1311(a), 16 N.J.R. 3203(a).
Substituted "registrant" for "person".
Amended by R.1992 d.241, effective 6/15/1992.
See: 23 N.J.R. 1911(a), 24 N.J.R. 2256(a).
Carfentanil added to (g).
Amended by R.2002 d.276, effective 8/19/2002.
See: 33 N.J.R. 2754(a), 34 N.J.R. 3024(a).
Rewrote (a), (b) and (c).