N.J. Admin. Code § 13:39-4.15

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

Section 13:39-4.15 - Security of pharmacies and pharmacy departments

(a) The pharmacist(s) on duty in all pharmacies, including pharmacy departments, shall be responsible for:

1. Keeping the pharmacy or pharmacy department closed and the security system turned on at all times when he or she is not present within the permitted premises in the case of a pharmacy, or, in the case of a pharmacy department, when he or she is not present within the department, except as provided in N.J.A.C. 13:39-6.4;

i. In the case of a pharmacy or pharmacy department that has been issued an institutional permit, pharmacy technicians may remain within the permitted premises when the pharmacy or pharmacy department is closed and secured, if the pharmacist determines, based on his or her professional judgment, that the security of prescription legend drugs, devices and controlled substances will be maintained in the pharmacist's absence;

2. Ensuring that the security of the prescription dispensing area and its contents are maintained at all times, including the restriction of persons unauthorized by the pharmacist on duty from being present in the prescription dispensing area; and

3. Reporting all thefts or diversions of prescription legend drugs and devices and controlled substances, and any significant loss of prescription legend drugs and devices and controlled substances, to the pharmacist-in-charge or the pharmacy permit holder upon discovery. When determining whether a loss of prescription legend drugs or devices or controlled substances is significant, the following factors shall be considered, consistent with 21 CFR 1301.74(c):

i. The actual quantity of prescription legend drugs, devices or controlled substances missing in relation to the type of business;

ii. The specific prescription legend drug, device or controlled substance missing;

iii. Whether the loss of the prescription legend drug, device or controlled substance can be associated with access to those drugs, devices or controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the drugs, devices or controlled substances;

iv. A pattern of losses over a specific time period, whether the losses appear to be random and the results of efforts taken to resolve the losses;

v. If known, whether the specific prescription legend drugs, devices or controlled substances are likely candidates for theft or diversion; and

vi. Local trends and other indicators of the theft or diversion potential of the missing prescription legend drug, device or controlled substance.

(b) The holder of a pharmacy or pharmacy department permit and the pharmacist-in-charge of the pharmacy or pharmacy department shall ensure that:

1. All entrances to the pharmacy or pharmacy department are capable of being locked and are connected to a monitored security system that transmits an audible, visual or electronic signal warning of intrusion. The security system shall be equipped with a back-up mechanism to ensure notification or continued operation if the security system is tampered with or is disabled. Only the pharmacist-in-charge shall be responsible for the security of the keys and the security system access code to the pharmacy or pharmacy department;

2. If a theft or diversion of prescription legend drugs or devices or controlled substances, or a significant loss of prescription legend drugs or devices or controlled substances, as delineated in (a) above, is reported to the pharmacist-in-charge, the pharmacist-in-charge shall notify the holder of the pharmacy or pharmacy department permit of such report. The pharmacist-in-charge and the holder of the pharmacy or pharmacy department permit shall ensure that:

i. A written report is filed with the Board upon discovery of the theft or diversion or the significant loss of prescription legend drugs or devices; and

ii. A written report is filed with the Federal Drug Enforcement Administration upon discovery of the theft or diversion or any significant loss of controlled substances, consistent with Federal requirements. A copy of such report shall be filed with the Office of Drug Control, consistent with State requirements and with the Board;

3. There is a secure area for receiving packages known to contain prescription legend drugs and devices and controlled substances. No prescription drug shall be accepted during the hours the pharmacy or pharmacy department is closed unless adequate security for the storage of such shipments has been provided; and

4. If a drop-off device is utilized for prescriptions, it is of a one-way, irretrievable and secure design.

(c) In addition to the requirements set forth in (b) above, the holder of a pharmacy department permit and the pharmacist-in-charge of the pharmacy department shall also ensure that:

1. The pharmacy department is constructed so as to enable the closing off and securing of the department from the main store area. The department shall be separated from the main store area by a secured barrier or partition extending from the floor or fixed counter to the ceiling of either the department or main store and attached thereto;

2. All medications requiring supervision of a pharmacist, including dispensed medication, remain within the confines of the department when the pharmacist is not in the pharmacy department;

3. If the pharmacy department has a published telephone number that is the same as the one for the establishment in which the department is located, the caller is able to select the service or department to which he or she wants to be connected; and

4. The telephone number of the pharmacist-in-charge is available in the office of the manager of the establishment.

(d) The holder of a pharmacy or pharmacy department permit shall comply with any law and/or ordinance of the municipality in which the pharmacy or pharmacy department is located requiring the placement of a security key box on the exterior of the pharmacy or the premises in which the pharmacy department is located for purposes of permitting emergency access to the premises.

N.J. Admin. Code § 13:39-4.15

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