N.J. Admin. Code § 8:43F-9.4

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43F-9.4 - Pharmacy control policies and procedures

(a) The label of each participant's individual medication container or package shall be permanently affixed and contain the following information, except as provided by (b) and (c) below:

1. The participant's full name;

2. The prescriber's name;

3. The prescription number;

4. The name and strength of the medication;

5. The quantity dispensed;

6. Directions for use;

7. The date upon which the medication is dispensed;

8. The manufacturer's name if generic;

i. If a generic substitute is used, the medication shall be labeled in accordance with the Drug Utilization Review Formulary, 24:6E-1 et seq. and N.J.A.C. 8:71; and

9. The expiration date, if dispensed in any packaging other than the manufacturers original packaging, and in accordance with 13:39-5.9.

(b) If medications are dispensed to participants from out-of-State pharmacies, the facility shall request, in writing, each pharmacy to label medications in accordance with (a) above.

(c) The dispensed container for any product shall bear all auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgement of the dispensing pharmacy.

(d) Alternative medication delivery systems, such as unit-of-use, unit dose, or customized medication packages, shall be labeled, dispensed, stored, accounted for, and monitored in accordance with the New Jersey State Board of Pharmacy rules, N.J.A.C. 13:39, the United States Pharmacopeia, and generally accepted standards of pharmaceutical practice for medication distribution systems. Required information appearing on individually packaged medications or within an alternative medication delivery system need not be repeated on the label.

(e) Over-the-counter (OTC) medications may be kept as stock. These medications shall be approved by the pharmacy consultant, monitored for accountability, and labeled to include medication name, strength, manufacturer's name, lot number, expiration date, recommended dosage for OTC use (if repackaged), and applicable cautionary and/or accessory labeling.

N.J. Admin. Code § 8:43F-9.4

Amended by 53 N.J.R. 2204(a), effective 12/20/2021