N.J. Admin. Code § 13:39-11A.7

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

Section 13:39-11A.7 - Preparation of pharmacy generated products (PGPs) for over-the-counter sale

(a) A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a prescription or medication order provided that:

1. The product does not contain an ingredient that exceeds allowable strengths and doses for over-the-counter drugs; and

2. The finished product is not one for which a prescription or medication order is required.

(b) A finished product that is prepared pursuant to (a) above shall be properly labeled with the following:

1. The product name;

2. The name of all ingredients;

3. The strength or quantity of all active ingredients;

4. The package size;

5. Directions for use;

6. The use by date, consistent with the requirements of 13:39-11A.11;

7. The name, address, and telephone number of the pharmacy;

8. Any ancillary and cautionary instructions, as needed; and

9. As pertinent, the requirements for proper storage.

(c) A pharmacy generated product shall be sold directly to the consumer only after professional interaction or consultation between a pharmacist and the consumer.

(d) A pharmacy generated product shall be stored in such a manner as to be inaccessible to the public.

(e) A pharmacy generated product shall not be sold to any entity for resale purposes.

(f) The preparation of pharmacy generated products shall be documented in accordance with the requirements of 13:39-11A.15(b)1 and 6 through 14.

N.J. Admin. Code § 13:39-11A.7