Bill Text: NJ A3395 | 2012-2013 | Regular Session | Introduced
Bill Title: Requires compounding pharmacies be accredited by Pharmacy Compounding Accreditation Board.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2012-10-15 - Introduced, Referred to Assembly Regulated Professions Committee [A3395 Detail]
Download: New_Jersey-2012-A3395-Introduced.html
Sponsored by:
Assemblyman SEAN T. KEAN
District 30 (Monmouth and Ocean)
SYNOPSIS
Requires compounding pharmacies be accredited by Pharmacy Compounding Accreditation Board.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning compounding pharmacies and supplementing Title 45 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. A licensed pharmacy operating in this State that engages in the preparation of sterile or nonsterile compounded formulations for dispensing or administration to humans or animals pursuant to a prescription, or a pharmacy located in another state that ships, mails, distributes, or delivers in any manner, any such compounded medications pursuant to a prescription into this State, shall furnish documentation of its accreditation by the Pharmacy Compounding Accreditation Board to the New Jersey State Board of Pharmacy, no later than one year after the effective date of this act, as a condition of its continued authorization to dispense such compounded medications in this State.
2. The New Jersey State Board of Pharmacy, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) and in consultation with the Pharmacy Compounding Accreditation Board and the Commissioner of Health, shall adopt such rules and regulations as are necessary to carry out the purposes of this act.
3. This act shall take effect on the first day of the fourth month next following the date of enactment, but the New Jersey State Board of Pharmacy may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.
STATEMENT
This bill requires compounding pharmacies in New Jersey to be accredited by the Pharmacy Compounding Accreditation Board (PCAB).
Specifically, the bill stipulates that a licensed pharmacy operating in this State that engages in the preparation of sterile or nonsterile compounded formulations for dispensing or administration to humans or animals pursuant to a prescription, or a pharmacy located in another state that ships, mails, distributes, or delivers in any manner, any such compounded medications pursuant to a prescription into this State, is to furnish documentation of its accreditation by PCAB to the New Jersey State Board of Pharmacy, no later than one year after the effective date of this bill, as a condition of its continued authorization to dispense such compounded medications in this State.
The bill directs the State Board of Pharmacy, in consultation with PCAB and the Commissioner of Health, to adopt such rules and regulations as are necessary to carry out the purposes of the bill.
The bill takes effect on the first day of the fourth month following its enactment, but authorizes the State Board of Pharmacy to take prior anticipatory administrative action as necessary for its implementation.
There are about 3,000 compounding pharmacies nationwide that create customized versions of medications, and these medications represent as much as three percent of the roughly $300 billion in prescription drugs sold in the United States annually, according to the International Academy of Compounding Pharmacists. The deficient oversight of compounding pharmacies has gained greater attention nationwide from the reports of death and illness among patients exposed to fungal meningitis from tainted spinal steroid injections. State regulators, the federal Food and Drug Administration, and the pharmacy industry all share some responsibility for monitoring compounding pharmacies such as the New England Compounding Center, which shipped the contaminated steroid tied to the meningitis outbreak; however, no one government agency has full responsibility for overseeing these entities, and this has created a regulatory gap with respect to ensuring the safety and effectiveness of medications made by these pharmacies.
The purpose of this bill is to ensure the safety and effectiveness of medications dispensed by compounding pharmacies in New Jersey by requiring that these pharmacies document that they meet the nationally accepted quality assurance, quality control, and quality improvement standards required for PCAB accreditation. PCAB standards have been developed by a standards committee of compounding pharmacists, academics, and experts, and examples of its specific quality standards include requirements that accredited pharmacies: use only high-quality chemicals and equipment; ensure that their compounding pharmacists and pharmacy technicians receive regular, specialized training; evaluate the quality of their preparations through a system of testing; and have an effective recall mechanism that allows them to identify who received a particular compound.
PCAB requires a minimum 90-day history of compliance with its standards before a pharmacy is eligible for accreditation. PCAB performs a routine on-site survey of its accredited pharmacies every three years, and may select any of these pharmacies for an unannounced survey at any point during their accreditation cycle. PCAB was founded by the leading pharmacy organizations in the United States, which comprise its board of directors, including: the American College of Apothecaries; the National Community Pharmacists Association; the American Pharmacists Association; the National Alliance of State Pharmacy Associations; the International Academy of Compounding Pharmacists; the National Home Infusion Association; the National Association of Boards of Pharmacy; and the United States Pharmacopeial Convention.
