Sponsored by:
Senator ANGELA V. MCKNIGHT
District 31 (Hudson)
Senator ROBERT W. SINGER
District 30 (Monmouth and Ocean)
Co-Sponsored by:
Senator Johnson
SYNOPSIS
Establishes pharmacist licensing exemption for certain dialysis-related drugs and devices.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning certain dialysis-related drugs and devices and amending P.L.2003, c.280.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. Section 10 of P.L.2003, c.280 (C.45:14-49) is amended to read as follows:
10. a. Except as otherwise provided in this act, it shall be unlawful for any individual to engage in the practice of pharmacy unless currently licensed to practice under the provisions of [this act] P.L.2003, c.280 (C.45:14-40 et seq.).
b. The provisions of [this act] P.L.2003, c.280 (C.45:14-40 et seq.) shall not apply to the sale of any drug by a manufacturer or wholesaler or pharmacy to each other or to a physician, dentist, veterinarian or other person licensed to prescribe such drugs in their professional practice.
c. Practitioners authorized under the laws of this State to compound drugs and to dispense drugs directly to their patients in the practice of their respective professions shall meet the standards established by their respective licensing boards with respect to storage, handling, security, counseling, labeling, packing and record keeping requirements for the dispensing of drugs, or if no such standards exist, the same storage, handling, security, counseling, labeling, packaging and record keeping requirements for the dispensing of drugs applicable to pharmacists.
d. The provisions of P.L.2003, c.280 (C.45:14-40 et seq.) shall not apply to a drug manufacturer or wholesale drug distributor, to the extent the manufacturer or wholesale drug distributor is engaged in the distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease, provided the following criteria are met:
(1) the dialysate drugs or devices are approved by the United States Food and Drug Administration, as required by federal law;
(2) the dialysate drugs or devices lawfully are held by a manufacturer or a manufacturer’s agent that is properly registered as a manufacturer or wholesale drug distributor;
(3) the dialysate drugs or devices are held and delivered in original, sealed labeled packaging from the manufacturing facility;
(4) the dialysate drugs or devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt of a physician’s order;
(5) the manufacturer or manufacturer’s agent delivers the dialysate drugs or devices directly to:
(a) a patient with end-stage renal disease, or the patient’s designee, for the patient’s self-administration of dialysis therapy; or
(b) a health care provider or institution for administration or delivery of the dialysis therapy to a patient with end-stage renal disease; and
(6) the manufacturer shall contract with a consultant pharmacist that is properly registered by the board who will provide quality assurance assessments of home dialysis drug storage and distribution on a weekly basis.
(cf: P.L.2003, c.280, s.10)
2. This act shall take effect on first day of third month next following the date of enactment.
STATEMENT
This bill exempts drug manufacturers and wholesale drug distributors from the requirement of being a licensed pharmacist when they are engaged in the distribution of dialysate drugs or devices to patients with end-stage renal disease under certain circumstances.
Under the bill, drug manufacturers and wholesale drug distributors would not be subject to pharmacist licensing requirements to the extent that they are engaged in the distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease. For the purposes of the bill, the following would be required of the drugs and devices:
(1) approval by the United States Food and Drug Administration;
(2) be held by an entity that is properly registered;
(3) be held and delivered in original, sealed labeled packaging;
(4) delivery only by the manufacturer or the manufacturer’s agent and only upon receipt of a physician’s order;
(5) delivery is made to a patient, the patient’s designee, a health care provider, or an institution for administration or delivery of the dialysis therapy to the patient; and
(6) periodic oversight of manufacturers and distributors by a licensed pharmacist.