N.J. Admin. Code § 13:39-7.12

Current through Register Vol. 56, No. 8, April 15, 2024

Section 13:39-7.12 - Labeling

(a) The dispensed container for any product shall bear a permanently affixed label with at least the following information:

1. The pharmacy name and address;

2. The pharmacy telephone number;

3. The brand name, or if a generic, the brand name, if still available in the marketplace, and the name of the generic in the following form, with the generic name and brand name inserted as appropriate:

" ----------- Generic for ------------- "

If the brand name is not still available in the marketplace, the generic name.

4. The strength of medication, where applicable;

5. The quantity dispensed;

6. The date upon which prescription medication is dispensed;

7. A CDS cautionary label, where applicable;

8. The patient name;

9. The practitioner's name;

10. The prescription number;

11. Directions for use;

12. The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging.

i. For purposes of this paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container; and

13. For substituted biological products, the information required in N.J.A.C. 13:39-7.23(d).

(b) The patient name, the brand or generic name of the medication, and the directions for use shall appear in larger type, in a different color type, or in bolded type, in comparison to the other information required to appear on the label of the dispensed container pursuant to (a) above.

(c) In addition to the requirements set forth in (a) and (b) above, the dispensed container for any product shall bear all auxiliary labeling as recommended by the manufacturer.

(d) When, in the judgment of the pharmacist, directions to the patient or cautionary messages are necessary, either for clarification or to ensure proper administration, storage or use of the medication, the pharmacist may add such directions or cautionary messages to those indicated by the practitioner on the original prescription.

(e) In addition to the requirements set forth in this section, when a pharmacist dispenses a prescription for an opioid medication, the pharmacist shall affix, to the container, a warning label or sticker such that the label or sticker shall:

1. Contain the warning, "Opioid Risk of Addiction and Overdose." Punctuation and layout of the warning may be determined by the permitted pharmacy.

2. The warning label or sticker must be:

i. Red , orange, or yellow in color;

ii. Written in black color text;

iii. Printed with a font size of at least 10- point font that is print- or blockbased (that is, not cursive) such that the font and lettering shall be easily and clearly readable; and

iv. Placed on the side, not the bottom , of the bottle or box that contains the prescription label , or on the cap of the bottle.

N.J. Admin. Code § 13:39-7.12

New Rule, R.1999 d.196 effective 6/21/1999.
See: 30 N.J.R. 4113(a), 31 N.J.R. 253(a), 31 N.J.R. 1618(a).
Recodified from N.J.A.C. 13:39-5.9 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Rewrote (b) and added (c). Former N.J.A.C. 13:39-7.12, Disposal of unwanted drugs, recodified to N.J.A.C. 13:39-7.17.
Amended by R.2004 d.380, effective 10/4/2004 (operative April 2, 2005).
See: 36 N.J.R. 11(a), 36 N.J.R. 4480(a).
Rewrote the section.
Administrative correction.
See: 37 N.J.R. 1535(a).
Amended by R.2009 d.305, effective 10/5/2009.
See: 40 N.J.R. 5170(a), 41 N.J.R. 3840(a).
Deleted former (a)9; and recodified former (a)10 through (a)13 as (a)9 through (a)12.
Amended by R.2010 d.090, effective 6/21/2010.
See: 42 N.J.R. 132(a), 42 N.J.R. 1221(a).
Rewrote (a)3; in (a)9, substituted "practitioner's" for "prescriber"; and in (d), substituted "practitioner" for "prescriber".
Amended by R.2017 d.220, effective 12/4/2017.
See: 49 N.J.R. 1316(a), 49 N.J.R. 3761(a).
Rewrote (a)3; in (a)11, deleted "and" from the end; in (a)12i, substituted "; and" for a period; and added (a)13.
Amended by R.2022 d.004, effective 1/3/2022.
See: 53 N.J.R. 497(a), 54 N.J.R. 88(a).
Added (e).