N.J. Admin. Code § 13:39-4.19

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

Section 13:39-4.19 - Procedures for centralized prescription handling

(a) The four component functions of handling a prescription are intake, processing, fulfillment and dispensing.

(b) Central prescription handling entails two or more licensed pharmacies sharing responsibility for performing the four component functions of handling a prescription. For purposes of this section, the term "prescription" shall include medication orders when a healthcare facility is involved in any of the component functions of central prescription handling.

(c) The following pharmacies may engage in central prescription handling: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. The four component functions of handling a prescription shall be performed by the following pharmacies:

1. An intake or originating pharmacy, which is a pharmacy that received the patient's or prescribing practitioner's request to fill or refill a prescription. A central processing pharmacy or a central fill pharmacy, as delineated in (c)2 and 3 below, may be considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy as provided in 13:39-7.10 and 7.11 or if the patient requested the refill from that pharmacy;

2. A central processing pharmacy, which is a pharmacy that engages in prescription review by performing functions that may include, but are not limited to, data entry, prospective drug review, refill authorizations, interventions, patient counseling, claims submission, claims resolution and adjudication;

3. A central fill pharmacy, which is a pharmacy engaging in central prescription handling by filling and/or refilling prescriptions, which includes the preparation and packaging of the medication; and

4. A dispensing pharmacy, which is a pharmacy that receives the processed prescription and/or the filled or refilled prescription for dispensing to the patient or to the patient's authorized representative and that offers patient counseling regarding the dispensed medication.

(d) Two or more of the pharmacies delineated in (c) above may engage in central prescription handling provided:

1. Any or all of the pharmacies participating in central prescription handling have a contractual agreement to provide such services or have the same owner;

2. Prior to engaging in central prescription handling, all pharmacies that are parties to the central prescription handling obtain Board approval. If a participating pharmacy is located outside the State of New Jersey, the pharmacy shall have registered with the Board pursuant to 13:39-4.20. The pharmacies shall make a single application to the Board, delineating the scope of practice of each pharmacy and the specific rules in this chapter with which each pharmacy shall comply;

3. An audit trail is maintained that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) and the component function(s) performed by each, at the time the functions are performed, for each step of prescription handling that is required to be performed by a pharmacist, pharmacy technician, intern or extern pursuant to the requirements of this chapter. All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail. 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, the unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and appropriateness of each component function(s) shall be recorded in the audit trail. The 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 not less than five years from the date the prescription is filled or refilled. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the 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;

4. The dispensed prescription for any product bears a permanently affixed label with at least the following information:

i. The brand name, or if a generic, the brand name, if still available in the marketplace, and the name of the generic in the following form, with the generic name and brand name inserted as appropriate:

" ----------- Generic for ------------- "

If the brand name is not still available in the marketplace, the generic name.

ii. The strength of medication, where applicable;

iii. The quantity dispensed;

iv. The date upon which prescription medication is dispensed;

v. A CDS cautionary label, where applicable and when permitted by law;

vi. The patient name;

vii. The practitioner name;

viii. The prescription number;

ix. Directions for use;

x. The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging. For purposes of this paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container;

xi. All auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgment of the dispensing pharmacist;

xii. The name, address, and telephone number of any or all of the following:

(1) The intake pharmacy;

(2) The central processing pharmacy;

(3) The central fill pharmacy; and/or

(4) The dispensing pharmacy; and

xiii. For substituted biological products, the information required in N.J.A.C. 13:39-7.23(d).

5. The patient name, the brand or generic name of the medication, and the directions for use appear in larger type, in a different color type, or in bolded type, in comparison to the other information required to appear on the label of the dispensed container pursuant to (d)4 above;

6. The patient is provided with written information, either on the prescription label or with the prescription container, that indicates which pharmacy to contact if the patient has any questions about the prescription or the medication. The written information provided to the patient shall be in bold print, easily read, and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service shall be available at no cost to the pharmacy's primary patient population;

7. All pharmacies that are to engage in central prescription handling maintain a common policies and procedures manual which designates who shall be responsible for each of the component functions of handling the prescription and for ensuring compliance with the Board rules set forth in this chapter. The policies and procedures manual shall also include maintenance of the audit trail required by (d)3 above. The policies and procedures manual shall be made available to the Board upon request;

8. All pharmacies that are to engage in central prescription handling share a common electronic file; and

9. All pharmacies that are to engage in central prescription handling are responsible for ensuring that the prescription has been properly filled.

(e) A prescription for a controlled substance may be filled or refilled by pharmacies engaging in central prescription handling when permitted by law, consistent with Federal requirements set forth at 21 CFR 1300 et seq.

N.J. Admin. Code § 13:39-4.19

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