Saturday, August 31, 2013

From NABP Association Supports Member Boards With Development of Electronic Resource for Verifying Pharmacy Licensure State Compounding Pharmacy Inspection Programs Continue and Iowa Inspection Program Update

NABP member boards continue efforts to ensure the safety of compounded drug products, including a new initiative undertaken by the Association.
At the request of member state boards of pharmacy, NABP has begun develop- ing an electronic resource
to facilitate the sharing of pharmacy licensure and related information among the states. The Verified Pharmacy ProgramTM (VPPTM), scheduled to launch by the end of 2013, will store licensee data and inspection report compo- nents in a uniform format. Data will be available to boards of pharmacy with the aim of supporting licensing decisions, of par- ticular interest when boards are considering applications for nonresident licensure.
In addition to developing VPP, NABP continues to conduct pharmacy inspec- tions, including surveys of compounding pharmacies, on behalf of the Iowa Board of Pharmacy and in partner- ship with state agencies in New Jersey.

Verified Pharmacy Program
Relevant data on li- censed pharmacies will be stored in VPP in the form of a pharmacy e-Profile. Pharmacy e-Profiles will allow NABP to collect and verify the following infor-
mation for reporting to the boards of pharmacy:
Pharmacy licenses (resi- dent and nonresident).
(PIC) licenses (resident and nonresident).
Disciplinary information.
The pharmacy e-Profile will also indicate whether
a qualified inspection has been performed by the resi- dent state or a designated agent.
Information in the pharmacy e-Profiles will be accessible to boards through the Board e-Profile Connect interface. The informa-
tion will also be proactively reported to boards.

In requesting that the Association initiate the de- velopment of VPP, member boards noted that the sys- tem would be particularly beneficial when considering applications for licensure from nonresident pharma- cies. Under the current system, boards may be asked to make licensing decisions about nonresident phar- macies with incomplete or outdated information. Chal- lenges creating this situa- tion include differing laws and regulations, as well as differing levels of resources from board to board. For example, some boards may not have the fiscal or human resources to conduct the same frequency and type
of pharmacy inspections as others with more robust budgets.
To help address the differences in regulatory structure and operations among the boards, VPP
will facilitate the sharing
of licensure information about pharmacies across
the country. Several exist- ing NABP programs and services are the foundation for the development of VPP, including the Electronic Li- censure Transfer Program® (e-LTP®); NABP Clear- inghouse, which includes disciplinary information; accreditation programs; and inspection services.

In fact, VPP is a natu-
ral extension of e-LTP, on which the Association was founded. In developing VPP, the Association is building on the success of e-LTP to create a means for boards to share information pertinent to the licensure of pharma-
cies. Pharmacy e-Profiles will allow boards to verify that a qualified inspection of the facility has been conducted and its licensure status
in other states. A future planned capability is for the
pharmacy e-Profiles to be in- terconnected with e-Profiles for pharmacists and pharma- cy technicians. This capabil- ity would assist boards in tracking PICs to ensure they meet state requirements, including verifying licensure and reviewing disciplinary information of both resident and nonresident PICs.
The primary impetus for the VPP was the linking
of the November 2012 mul- tistate fungal meningitis outbreak to contaminated injectable drugs com- pounded by the New Eng- land Compounding Center (NECC), a tragedy that brought to the forefront the need for boards to be able to verify inspection and other data when licensing nonresident pharmacies. More information about VPP and an application will be available on the NABP Web site by the end of Sep- tember 2013. In addition to initiating the development of VPP following the NECC compounding tragedy, some member state boards of pharmacy requested NABP’s assistance in conducting compounding pharmacy inspections.
Iowa Inspection Program
NABP began conduct- ing pharmacy inspections on behalf of the Iowa Board of Pharmacy in December 2012. As of press time, NABP surveyors have conducted inspections of 384 nonresident pharma- cies dispensing drugs to patients in Iowa. Inspec- tions are ongoing across the nation and as such are not consigned to any one state. Aggregate data reports with relevant survey findings are submitted directly to the Iowa Board. Trends from 

Pharmacy Inspection Update
(continued from page 167)
expired compounded
drugs that were
“returned to stock.”
A facility where
a cleanroom was
identified as ISO Class 7 certified, though it failed to meet the criteria for
that designation.
Air changes per hour did not meet the standards at some facilities and
were significantly below the average observed at other pharmacies. (Cover articles in the
May 2013 NABP Newslet- ter and the June-July 2013 NABP Newsletter provide additional background and updates on the Iowa compounding inspection program.)
New Jersey Inspections
The state of New Jersey has also requested the assistance of NABP to con- duct inspections of New Jersey pharmacies engaged
in the practice of com- pounding. NABP survey- ors are assisting the New Jersey Division of Con- sumer Affairs (Division) with planned inspections, under a contract with the Division and the state’s Attorney General Jeffrey S. Chiesa. NABP surveyors began inspections in mid- July 2013. Updates on the program will be provided in future Newsletters.
Future Actions
Through the leadership and guidance of its mem- ber boards, NABP will continue efforts aimed to- ward ensuring the safety of compounded medications. At the NABP 109th An- nual Meeting in May 2013, members adopted three resolutions pertaining to compounding. Resolu- tion 109-1-13 in particular calls on the Association to encourage boards of phar- macy to reference sterile compounding quality stan-
dards, including but not limited to those contained in United States Pharma- copeia Chapter <797>, as the standard for sterile compounding in their state. Further, in accor- dance with the resolution, NABP will also encourage boards to conduct quali- fied surveys of pharmacies. NABP will also review its Model State Pharmacy Act and Model Rules of the Na- tional Association of Boards of Pharmacy and determine if it is necessary to make amendments addressing the appropriate regulation and inspection of pharma- cies engaged in sterile com- pounding.
The Association will continue to provide up- dates on actions taken to support member boards in their efforts to strengthen regulation of compound- ing in order to prevent an- other incident such as the meningitis outbreak linked to NECC products.
the reports were shared by Lloyd K. Jessen, JD, RPh, executive director/drug control program adminis- trator, Iowa Board of Phar- macy, during a continuing pharmacy education session at the NABP 109th Annual Meeting, May 18-21, 2013. (See the 2013 Special Issue of the NABP Newsletter for details.) Additional observa- tions from Iowa inspections include the following:
Compounded products being shipped to states where the pharmacy did not hold a pharmacy
  • license.
    Products being shipped
    “for office use” to entities that did not hold a pharmacy license in
  • that state.
    Sterile products being

  • improperly labeled. Facilities with improperly labeled or  

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