N.J. Admin. Code § 13:39-11.23

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

Section 13:39-11.23 - Policy and procedures manual

(a) The pharmacy's policy and procedures manual shall set forth in detail the pharmacy's standard operating procedures with regard to compounded sterile preparations.

(b) The policy and procedures manual shall include policies and procedures governing the following:

1. A risk-management program, including, but not limited to, documentation of incidents, adverse drug reactions, and product contamination.

i. The risk-management program shall require that the pharmacist-in-charge report all confirmed incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of becoming aware of such incidents;

2. Security measures ensuring that the premises where compounded sterile drugs are present are secured, so as to prevent access by unauthorized personnel;

3. Equipment;

i. Procedures for use; and

ii. Documentation of appropriate certifications;

4. Cleaning and disinfecting standards and procedures, consistent with the requirements of 13:39-11.15;

5. Reference materials as set out in 13:39-5.8 and 11.12(b)12;

6. Information concerning drug:

i. Preparation;

ii. Storage and handling;

iii. Dispensing;

iv. Labeling;

v. Delivery; and

vi. Destruction, recalls and returns;

7. Patient recordkeeping as set forth in 13:39-11.12(b)14;

8. Handling, dispensing and documentation of investigational new drugs;

9. A quality assurance program as set forth in 13:39-11.24;

10. Verification of training and competency guidelines as set forth in 13:39-11.16;

11. Compounding process validation;

12. Documentation as set forth in 13:39-11.20;

13. Description of appropriate garb and garbing procedures, consistent with the requirements of 13:39-11.14;

14. Conduct guidelines for personnel in the cleanroom;

15. Personnel responsibilities;

16. Patient education;

17. Protocol and procedures to maintain the integrity of the interior work area of the laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets; and

18. Written procedures in compliance with the Occupational Safety and Health Administration standards for handling small and large spills of antineoplastic agents and other hazardous substances.

(c) The policy and procedures manual shall be reviewed, at a minimum, once every 24 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the Board upon request.

N.J. Admin. Code § 13:39-11.23

The following annotations apply to N.J.A.C. 13:39-11.23 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. 13:39-11.24 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Substituted "ISO class 5" for "class 10 to class 100" following "Self contained" and "engaging in the compounding of sterile preparations" for "engaging in sterile product preparation". Former N.J.A.C. 13:39-11.23, Laminar air flow hoods not in a clean room, recodified to N.J.A.C. 13:39-11.22.
The following annotations apply to N.J.A.C. 13:39-11.23 subsequent to its recodification from N.J.A.C. 13:39-11.13 by R.2013 d.084:
Recodified from N.J.A.C. 13:39-11.8 and amended by R.1998 d.297, effective 6/15/1998.
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Rewrote (b). Former N.J.A.C. 13:39-11.14, Controlled environment: maintenance and supplies, was recodified to N.J.A.C. 13:39-11.19(c) through (e).
Amended by 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).
In (b), added 18.
Recodified from N.J.A.C. 13:39-11.14 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 "with regard to compounded sterile preparations" for "with regard to sterile admixture services"; in (b), substituted "where compounded sterile drugs are present" for "where sterile admixture drugs are present" following "that the premises" in 2 and amended the N.J.A.C. references in 5, 7, 9 and 12; in (c), inserted "at least every two years" following "in charge shall review", substituted "as needed" for "on at least an annual basis" following "policy and procedure manual" and deleted "annual" following "Documentation of the". Former N.J.A.C. 13:39-11.13, Handling, packaging and delivery, recodified to N.J.A.C. 13:39-11.12.
Recodified from N.J.A.C. 13:39-11.13 and amended by R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Section was "Policy and procedure manual for compounded sterile preparations". Rewrote the section. Former N.J.A.C. 13:39-11.23, Controlled environment for compounded sterile preparations: self-contained sterile glove boxes, repealed.