Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, May 30, 2013
NABP Surveyors to Assist With New Jersey Compounding Pharmacy Inspections Under Contract With the State
Under a contract with the New Jersey Division of Consumer Affairs (Division) and the state’s Attorney General Jeffrey S. Chiesa, NABP will assist the Division with inspections of New Jersey pharmacies engaged in the practice of compounding. The planned pharmacysurveys will expand the Division’s already robust inspections of compounding pharmacies. As noted in a Division press release, New Jersey State Board of Pharmacy regulations hold compounding pharmacies to “stringent compounding standards, mirroring those of the U.S. Pharmacopeial Convention” and the Division’s inspectors have routinely inspected the state’s pharmacies to ensure compliance with regulations. The contract with NABP will enable New Jersey “inspectors to draw upon a greater body of expertise and experience to address this growing industry,” indicates Chiesa. Chiesa stated further that the Division “will act immediately on any violations that appear to threaten the public’s health and safety.” The expanded compounding pharmacy inspections have been initiated as a result of contamination issues discovered at Med Prep Consulting, Inc, in Tinton, NJ, and similar reports of contamination at compounding facilities in other states, as well as the fungalmeningitis outbreak linked to contaminated products compounded by the New England Compounding Center in Framingham, MA. New Jersey’s contract with NABP enables the Division to temporarily employ NABP inspectors on an as-needed basis.
Similar inspection programs are under consideration in a number of other states, and NABP is in discussion with these states regarding how the Association can assist with these efforts to ensure the safety of compounded medications. In addition, NABP plans to establish an e-Profile for each pharmacy in the US, which will include verifications of licensure, disciplinary checks, and verification that a timely and robust inspection has occurred for each pharmacy, including those performing sterile and nonsterile compounding. The information in the e-Profiles for pharmacies will be sent proactively to boards of pharmacy for use in making licensure and registration determinations for nonresident pharmacies.
A compounding inspection program conducted by NABP on behalf of the Iowa Board of Pharmacy was initiated in mid-December and is ongoing. More information about the Iowa compounding pharmacy inspection program and the information sharing network under development by NABP is included in the April 2013 NABP Newsletter article “Compounding Pharmacy Information Sharing Network Available to Boards Soon” (PDF).