N.J. Admin. Code § 13:39-7.6

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-7.6 - Required records and documents

(a) A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-4.19, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)3 is not required to be, but may be, recorded in the audit trail.

(b) All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. When more than one pharmacist is involved in the component functions of prescription handling, each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each component function(s) is performed.

(c) Computer systems employed for audit trail documentation shall be designed to identify and document the unique and secure identifier for all pharmacists, pharmacy technicians, interns and externs who utilize the system. Computer systems that automatically generate the unique and secure user identifier of a pharmacist, pharmacy technician, intern or extern without requiring an entry by the responsible party are prohibited.

(d) Appropriate documentation identifying the unique and secure user identifier of all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained by the pharmacy for a period of not less than five years after the last date of employment. If a pharmacy utilizes a manual system, appropriate documentation identifying the handwritten initials with the handwritten signature and printed name of all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained for a period of not less than five years after the last date of employment. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure.

(e) All audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(f) Notwithstanding the requirements of (d) above, a pharmacy shall maintain prescription records for controlled dangerous substances as required by Federal law consistent with the provisions of 21 CFR 1304.04.

N.J. Admin. Code § 13:39-7.6

Amended by 49 N.J.R. 3761(a), effective 12/4/2017