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
Showing posts with label Indiana Board of Pharmacy. Show all posts
Showing posts with label Indiana Board of Pharmacy. Show all posts
Thursday, March 6, 2014
Friday, March 8, 2013
INDIANA BOARD OF PHARMACY Will meet on Monday, March 11, 2013 8:30 a.m
INDIANA BOARD OF PHARMACY
Will meet on Monday, March 11, 2013 8:30 a.m.
Indiana Government Center South 402 West Washington Street Room W064 Indianapolis, Indiana 46204
I. PROBATIONARY APPEARANCES (W064) 7:30 a.m.
A. Douglas Anderson K. Dennis Mann B. Julie Coble L. Yomot McCloud C. Dennis Flanagan M. Nicholas Meyers D. Mark Fritz N. Jordon Nuger E. Thomas Goodge O. Arthur Pasquinelli F. Sandra Hayes P. Daniel Rushton G. Donovan Higgins Q. Amber Rodda H. Robert Hudson R. Donnielle Shead I. Travis Kleingartner S. Kathrine Walters J. Mark Lawson
CALL TO ORDER AND ESTABLISHMENT OF QUORUM 8:30 a.m.
II. PLEDGE OF ALLEGIANCE
III. ADOPTION OF THE AGENDA
IV. APPROVAL OF THE MINUTES FROM THE February 11, 2013 MEETING
V. FULL BOARD APPEARANCES 8:30 a.m. i. Dr. Hinchman ii. Ryan Freger - Pyxis iii. Cactus Sink
VI. STANDING COMMITTEE MEETINGS 9:30 – 11:00 a.m. A. Administration and Licensing Committee (Room W064) Appearances i. Health Care – Pharmacy Technician School ii. Emmy Kesler – pharmacy technician application– positive response iii. Wendy Stevens – pharmacy
Wednesday, February 13, 2013
Indiana Board of Pharmacy Revokes NECC's License
| 2/12/2013 Entry Description
INDIANAPOLIS – The Indiana Board of Pharmacy agreed to revoke the New England Compounding Center’s license for its connection to the meningitis outbreak.
The Massachusetts-based pharmacy reached a voluntary revocation agreement on Friday with Indiana Attorney General Greg Zoeller’s office. The board approved the agreement Monday during its meeting in Indianapolis.
“Public health and safety is a top priority and today’s action was a necessary step to ensure this company, which put patients unnecessarily at risk, does not operate within our state’s borders going forward,” Zoeller said.
Zoeller said a license revocation means the company cannot operate in Indiana for at least seven years. The company could apply for a new license after that time, but the board would have to approve the license application.
In November, the Indiana Board of Pharmacy voted to indefinitely suspend NECC’s non-resident pharmacy license and the Attorney General’s office recently filed a licensing complaint against the company. Zoeller said the pharmacy failed to ensure its epidural steroid injections were safe for patients which led to devastating harm.
As of Feb. 4, the U.S. Centers for Disease Control (CDC) identified 10 deaths and 79 total cases of fungal meningitis in Indiana stemming from epidural steroid injections produced by NECC. Nationwide there were a total of 696 cases and 45 deaths across 20 states.
In September, the CDC in coordination with the Food and Drug Administration identified the NECC as the compounding pharmacy that produced the epidural steroid injections that caused the onset of meningitis in certain patients. Shortly after, NECC ceased production and initiated a recall of the drugs.
As a licensed non-resident pharmacy whose products were distributed and sold in Indiana, NECC is legally responsible for the “proper and safe storage and distribution of drugs and devices.”
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| Contact Information: Name: Erin Reece Phone: 317.232.0168 Email: Erin.Reece@atg.in.gov Source found here |
Sunday, January 27, 2013
Indiana Board of Pharmacy Rule Change
Synthetic Drug Emergency Rules
Synthetic Drug Emergency Rules
Indiana Code 25-26-13-4.1 gives the Indiana Board of Pharmacy the authority to adopt emergency rules declaring a substance to be a synthetic drug if the substance has been scheduled or emergency scheduled by the DEA or scheduled, emergency scheduled, or criminalized by another state.
Controlled substances listed in IC 35-48-2-4 are included in Schedule I. “Synthetic drugs,” as defined in IC 35-31.5-2-321, are listed as Schedule I drugs under IC 35-48-2-4(d)(35). Indiana Code 35-31.5-2-321(9) includes in the definition of synthetic drug “any compound determined to be a synthetic drug by rule adopted under IC 25-26-13-4.1.”
The Indiana Board of Pharmacy has promulgated the following emergency rules in accordance with IC 35-26-13-4.1:
LSA #12-493(E)
Indiana Code 25-26-13-4.1 gives the Indiana Board of Pharmacy the authority to adopt emergency rules declaring a substance to be a synthetic drug if the substance has been scheduled or emergency scheduled by the DEA or scheduled, emergency scheduled, or criminalized by another state.
Controlled substances listed in IC 35-48-2-4 are included in Schedule I. “Synthetic drugs,” as defined in IC 35-31.5-2-321, are listed as Schedule I drugs under IC 35-48-2-4(d)(35). Indiana Code 35-31.5-2-321(9) includes in the definition of synthetic drug “any compound determined to be a synthetic drug by rule adopted under IC 25-26-13-4.1.”
The Indiana Board of Pharmacy has promulgated the following emergency rules in accordance with IC 35-26-13-4.1:
LSA #12-493(E)
Thursday, January 17, 2013
Indiana AG files licensing complaint against NECC
By Bryan Cohen
INDIANAPOLIS (Legal Newsline) – Indiana Attorney General Greg Zoeller filed a licensing lawsuit Wednesday against the Massachusetts-based pharmacy that is linked to an outbreak of meningitis that killed 37 people across 19 states.
In November, Indiana’s Board of Pharmacy voted to indefinitely suspend the non-resident pharmacy license of the New England Compound Center. The formal licensing complaint will be considered by the board at its February 11 meeting to determine punitive measures.
“This pharmacy failed to ensure its epidural steroid injections were safe for patients which led to devastating harm,” Zoeller said. “This formal licensing complaint against the New England Compounding Center will soon be considered by the Indiana Board of Pharmacy which has the authority to determine the appropriate discipline.”
There were a total of 568 cases and 37 deaths across 19 states as a result of the fungal meningitis stemming from epidural steroid injections produced by NECC. As of Dec. 12, the U.S. Centers for Disease Control and Prevention had identified six deaths and 63 cases in Indiana alone.
In September, the CDC and the U.S. Food and Drug Administration identified NECC as the compounding pharmacy that produced the injections. Subsequently, NECC ceased production of the steroid injections and initiated a recall of the drugs.
As a licensed non-resident pharmacy distributing and selling products in Indiana, NECC is legally responsible for safe and proper storage and distribution of devices and drugs.
Zoeller
“This pharmacy failed to ensure its epidural steroid injections were safe for patients which led to devastating harm,” Zoeller said. “This formal licensing complaint against the New England Compounding Center will soon be considered by the Indiana Board of Pharmacy which has the authority to determine the appropriate discipline.”
There were a total of 568 cases and 37 deaths across 19 states as a result of the fungal meningitis stemming from epidural steroid injections produced by NECC. As of Dec. 12, the U.S. Centers for Disease Control and Prevention had identified six deaths and 63 cases in Indiana alone.
In September, the CDC and the U.S. Food and Drug Administration identified NECC as the compounding pharmacy that produced the injections. Subsequently, NECC ceased production of the steroid injections and initiated a recall of the drugs.
As a licensed non-resident pharmacy distributing and selling products in Indiana, NECC is legally responsible for safe and proper storage and distribution of devices and drugs.
Monday, December 24, 2012
Indiana State Board of Pharmacy Addresses Sterile Compounding Issue
D. Sterile Compounding Discussion (after administrative hearings)
The Board discussed sterile compounding and the recent meningitis outbreak. The Board discussed the fact that not all states inspect pharmacies, as the Board had previously believed. The Board directed the staff to request information from nonresident pharmacies regarding their compounding practices, including their last inspection report and USP 795/797 compliance. This information must be supplied to the Board by December 31, 2012. The Board plans to use this information to help develop an appropriate response to this issue. All nonresident pharmacy applications will be reviewed by the Board, which may delay processing of these applications. The Board discussed the possibility of having a committee regarding this issue. The Board also plans to further investigate third party inspections and accreditation options.
To review complete minutes of the November 5, 2012 meeting click here
Sunday, December 16, 2012
Indiana Board of Pharmacy November Meeting Discussion on Compounding
D. Sterile Compounding Discussion (after administrative hearings)
The Board discussed sterile compounding and the recent meningitis outbreak. The Board discussed the fact that not all states inspect pharmacies, as the Board had previously believed. The Board directed the staff to request information from nonresident pharmacies regarding their compounding practices, including their last inspection report and USP 795/797 compliance. This information must be supplied to the Board by December 31, 2012. The Board plans to use this information to help develop an appropriate response to this issue. All nonresident pharmacy applications will be reviewed by the Board, which may delay processing of these applications. The Board discussed the possibility of having a committee regarding this issue. The Board also plans to further investigate third party inspections and accreditation options.
Minutes of meeting found here
Sunday, December 9, 2012
Indiana Board of Pharmacy to Continue Discussion Regarding Compounding at Next Board Meeting
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Saturday, November 17, 2012
Indiana Also Discussed Sterile Compounding During November Meeting and Suspension of NECC
To view the agenda click here and then click on November 2012 agenda.
Indiana Board of Pharmacy Statement regarding compounding pharmacies
October 11, 2012
Indiana Board of Pharmacy
Statement regarding compounding pharmacies
The Indiana Board of Pharmacy takes patient safety very seriously, and the Indiana Code
and our administrative rules are aimed at protecting the public. Compounding is an
integral part of the practice of pharmacy. Compounding is safe when conducted within
the confines of the law and when it does not extend into the realm of manufacturing.
Sterile compounding is addressed at 856 IAC 1-30, and pharmacies engaging in sterile
compounding must comply with the USP 797 national standards. In-state pharmacies,
including those engaging in sterile compounding, are subject to inspection by the Board
of Pharmacy’s Compliance Officers. The Board’s administrative rules and our
inspections of sterile compounding facilities address, among other things: policies and
procedures; engineering controls/physical requirements; personnel training; labeling and
documentation/records and reports; and quality assurance measures. The Board of
Pharmacy works hard to ensure that our licensed facilities are thoroughly inspected.
Non-resident pharmacies registered in Indiana are required by Indiana Code to comply
with the laws and rules of the state in which they are domiciled. In order to be registered
as an Indiana non-resident pharmacy, an applicant must submit numerous documents and
fulfill various duties, including verification of the pharmacy’s licensure in its home state.
The Indiana Board of Pharmacy relies on other state Boards of Pharmacy to regulate
licensees in their jurisdiction.
The Board is following the developments of the meningitis outbreak closely. The New
England Compounding Center is licensed in Indiana as a non-resident pharmacy. The
Board has referred the matter to the Office of the Indiana Attorney General for
investigation.
Patient safety is of utmost importance to the Indiana Board of Pharmacy. The Board of
Pharmacy Compliance Officers thoroughly inspect our licensees with the aim of ensuring
patient safety.
Statement can be found here
Saturday, October 20, 2012
Statement from Indiana Board of Pharmacy Regarding New England Compounding Center
October 11, 2012
Indiana Board of Pharmacy Statement regarding compounding pharmacies
The Indiana Board of Pharmacy takes patient safety very seriously, and the Indiana Code and our administrative rules are aimed at protecting the public. Compounding is an integral part of the practice of pharmacy. Compounding is safe when conducted within the confines of the law and when it does not extend into the realm of manufacturing.
Sterile compounding is addressed at 856 IAC 1-30, and pharmacies engaging in sterile compounding must comply with the USP 797 national standards. In-state pharmacies, including those engaging in sterile compounding, are subject to inspection by the Board of Pharmacy’s Compliance Officers. The Board’s administrative rules and our inspections of sterile compounding facilities address, among other things: policies and procedures; engineering controls/physical requirements; personnel training; labeling and documentation/records and reports; and quality assurance measures. The Board of Pharmacy works hard to ensure that our licensed facilities are thoroughly inspected.
Non-resident pharmacies registered in Indiana are required by Indiana Code to comply with the laws and rules of the state in which they are domiciled. In order to be registered as an Indiana non-resident pharmacy, an applicant must submit numerous documents and fulfill various duties, including verification of the pharmacy’s licensure in its home state. The Indiana Board of Pharmacy relies on other state Boards of Pharmacy to regulate licensees in their jurisdiction.
The Board is following the developments of the meningitis outbreak closely. The New England Compounding Center is licensed in Indiana as a non-resident pharmacy. The Board has referred the matter to the Office of the Indiana Attorney General for investigation.
Patient safety is of utmost importance to the Indiana Board of Pharmacy. The Board of Pharmacy Compliance Officers thoroughly inspect our licensees with the aim of ensuring patient safety.
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