N.J. Admin. Code § 13:39-11.21

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

Section 13:39-11.21 - Information required to appear on prescription label

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

1. The date and time prepared;

2. In the retail pharmacy only, the name of the prescriber;

3. The name of the patient;

4. Directions for use;

5. The name and strength or quantity of all active ingredients, and the name and volume of the diluent, vehicle, and base solution(s), if applicable;

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

7. The phrase "use by" followed by the preparation's use by date and time (if no time is stated, it is presumed to be 11:59 P.M. of the stated use by date).

8. Any ancillary and cautionary instructions as needed;

9. As pertinent, a warning, consistent with applicable Federal and State law, that antineoplastic agents and other hazardous substances are biohazardous;

10. As pertinent, the requirements for proper storage; and

11. In a retail pharmacy, for those medications not dispensed pursuant to the requirements of N.J.A.C. 13:39-9, the prescription number.

(b) For immediate use compounded sterile preparations, when the preparation is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, the compounded sterile preparation shall be labeled consistent with the requirements of (a) above and shall also include the name or identifier of the person who prepared the compounded sterile preparation.

N.J. Admin. Code § 13:39-11.21

The following annotations apply to N.J.A.C. 13:39-11.21 prior to its repeal by R.2013 d.084:
New Rule, R.1998 d.297, effective 6/15/1998.
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Recodified from N.J.A.C. 13:39-11.22 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
In (a), substituted "an ISO class 5" for "a class 100". Former N.J.A.C. 13:39-11.21, Controlled environment: anteroom, recodified to N.J.A.C. 13:39-11.20.
The following annotations apply to N.J.A.C. 13:39-11.21 subsequent to its recodification from N.J.A.C. 13:39-11.10 by R.2013 d.084:
Recodified from N.J.A.C. 13:39-11.5 and amended by R.1998 d.297, effective 6/15/1998.
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
In (a), inserted a reference to time in 1, and rewrote 2 and 10. Former N.J.A.C. 13:39-11.11, Controlled environment: entry, was recodified to N.J.A.C. 13:39-11.17.
Recodified from N.J.A.C. 13:39-11. 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 (a). Former N.J.A.C. 13:39-11.10, Documentation, recodified to N.J.A.C. 13:39-11.9.
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)6; and recodified former (a)7 through (a)11 as (a)6 through (a)10.
Recodified from N.J.A.C. 13:39-11.10 and amended by R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
In the introductory paragraph of (a), inserted "sterile"; rewrote (a)1, (a)5, (a)7, and (a)9; in (a)10, substituted "; and" for a period at the end; and added (a)11 and (b). Former N.J.A.C. 13:39-11.21, Vertical air laminar flow hoods for compunded sterile preparations, repealed.