N.J. Admin. Code § 13:39-10.4

Current through Register Vol. 56, No. 17, September 3, 2024

Section 13:39-10.4 - Written policies and procedures of operation

(a) When an automated medication system is used to fill prescriptions or medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall:

1. Include a table of contents;

2. Include a description of all procedures of operation;

3. Set forth methods that shall ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least two years after the change is made. Each such change shall be signed or initialed by the pharmacist-in-charge and shall include the date on which the pharmacist-in-charge approved the change;

4. Set forth methods that shall ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made;

5. Set forth methods to identify the quality control measures in place to ensure the accuracy of the final dispensed product;

6. Set forth methods that shall ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records, for the purpose of complying with 13:39-7.19;

7. Set forth methods that shall ensure that access to the automated medication system for stocking and retrieval of medications is limited to licensed practitioners or qualified pharmacy technicians, interns and externs under the supervision of a pharmacist. An accountability record, which documents all transactions relative to stocking and removing medications from the automated medication system shall be maintained; and

8. Identify the circumstances under which medications may be removed from the automated medication system by a licensed practitioner for distribution to a patient without prior order review by a pharmacist.

(b) A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall, at least annually, review its written policies and procedures of operation and revise them if necessary.

(c) A copy of the written policies and procedures of operation adopted pursuant to this section shall be retained at the pharmacy and at the healthcare facility where the automated medication system is utilized. Upon request, the pharmacy shall provide to the Board a copy of the written policies and procedures of operation for inspection and review.

N.J. Admin. Code § 13:39-10.4

Amended by R.2009 d.305, effective 10/5/2009.
See: 40 N.J.R. 5170(a), 41 N.J.R. 3840(a).
In (a)5, substituted "N.J.A.C. 13:39-7.19" for "N.J.A.C. 13:39-7.14(h)".
Amended by R.2010 d.090, effective 6/21/2010.
See: 42 N.J.R. 132(a), 42 N.J.R. 1221(a).
In (a)3, substituted "pharmacist-in-charge" for "registered pharmacist in charge" twice; added new (a)5; recodified former (a)5 through (a)7 as (a)6 through (a)8; in (a)7 and (a)8, deleted "registered" preceding "pharmacist"; and in (a)7, substituted "pharmacy technicians, interns and externs" for "support personnel acting" and inserted a comma following "record".