N.J. Admin. Code § 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 N.J.A.C. 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 N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.

Notes

N.J. Admin. Code § 13:39-11A.7