N.J. Admin. Code § 13:39-7.15

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

Section 13:39-7.15 - Restriction on sale of Schedule V over-the-counter controlled substances

(a) It shall be considered unprofessional conduct for a pharmacist to dispense a Schedule V over-the-counter controlled substance when:

1. The pharmacist, in his or her professional judgment, knows or reasonably should know that the requested substance will be used for unauthorized or illicit consumption or distribution; or

2. The pharmacist, in his or her professional judgment, knows or reasonably should know that the person requesting the substance previously used it for unauthorized or illicit consumption or distribution.

(b) The standard of professional judgment and care that attends the sale of a Schedule V over-the-counter controlled substance shall conform to the following:

1. All pharmacists shall comply with 13:45H-7.19, which requires that the sale of specified controlled substances be limited in quantity during any 48-hour period, that the purchaser be at least 18 years of age, and that the pharmacist obtain suitable identification (including proof of age where appropriate) from every purchaser not known to the pharmacist.

2. In all instances, any doubts regarding the propriety of a sale of a Schedule V substance shall be resolved against making the sale.

3. The pharmacist shall enter every sale of a Schedule V substance in the Over-the-Counter Schedule V Record Book pursuant to 13:45H-7.19. The information to be recorded shall include the purchaser's first and last name, street address, city and state, the name and quantity of the Schedule V substance sold, the date of each sale, and the name or initials of the pharmacist making the sale.

4. Upon an individual's second request for a Schedule V substance within a short period of time (two to four days), the pharmacist shall determine, through direct communication with the purchaser, whether the substance is being used correctly. In that regard, the pharmacist shall ascertain how many people are using the substance and whether the condition which the substance is being used to treat is improving.

5. Upon an individual's third request for a Schedule V substance within a short period of time relative to the number of persons using it (two to four days subsequent to the second purchase), the pharmacist shall advise the purchaser of the substance's abuse potential and shall caution the purchaser to consult a physician if the condition for which the substance is being used does not improve.

6. Upon an individual's fourth request for a Schedule V substance within a short period of time (two to four days subsequent to the third purchase), the pharmacist shall determine, through direct communication with the purchaser, how many people are using the substance, whether continued use will be therapeutic, whether the purchaser is treating a condition which requires a physician's consultation, whether the purchaser is exhibiting signs of drug abuse and whether the purchaser is making similar requests of other local pharmacies.

7. If a pharmacist determines that an individual's request for a Schedule V substance within a short period of time (two to four days) subsequent to his or her fourth purchase is warranted, the pharmacist shall document in the Over-the-Counter Schedule V Record Book the justification for such sale. In addition, the pharmacist shall recommend that the purchaser consult with a physician for medical evaluation due to the substance's abuse potential as well as the potential hazard presented by the substance's continued use.

8. If any Schedule V substance is dispensed to one individual more than five times within any 12-month period, the pharmacist shall obtain oral or written confirmation from the purchaser's physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book.

N.J. Admin. Code § 13:39-7.15

New Rule, R.1990 d.478, effective 10/1/1990.
See: 22 N.J.R. 1329(a), 22 N.J.R. 3153(b).
Recodified from N.J.A.C. 13:39-6.8 by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Administrative change.
See: 43 N.J.R. 1204(b).