d. Discussion and Possible Action on Request from Det Norske Veritas to Renew Board of
Pharmacy Approval as an Accreditation Agency for Licensed Sterile Injectable
Compounding Pharmacies
Relevant Statutes
Business and Professions Code Sections 4127 – 4127.8 provides for the regulation of
pharmacies that compound sterile injectable drug products in a pharmacy. Pharmacy law
creates an exemption from the licensure requirements for a pharmacy that is accredited by a
private accreditation agency approved by the board (B&PC 4127.1 (d) and 4127.2 (c).
Background
For the past several years the board has been discussing several elements of pharmacies that
compound sterile injectable products, including the requirements for private accreditation
agencies. As part of the current approval process, such agencies apply to the board for
consideration and approval by the board.
Det Norske Veritas (DNV) was previously approved by the board for a three year period. This
approval will expire later this year. As such DNV has submitted a new request to the board.
Regrettably because the April Licensing Committee meeting was rescheduled, a representative
from DNV was unable to attend the committee meeting. The committee recommended to the
board to extend DNV’s approval for three months so that DNV would be able to attend the May
Licensing Committee meeting. The board approved this recommendation.
Supervising Inspector Janice Dang conducted an inspection of four hospitals accredited by DNV.
This summary was provided as part of the meeting materials.
The committee discussed the summary of inspections for the four hospitals accredited by DNV
inspected by Supervising Inspector Janice Dang. DNV was not present at the Licensing
Committee meeting. Chair Veale advised the committee of pending legislation SB 294
(Emerson) that if approved, will supersede accrediting approval by the board. Chair Veale
indicated if the bill fails, accreditation in lieu of licensure will be allowed.
A summary of hospital pharmacy initial and follow up inspections of hospital accredited by Det
Norske Veritas Healthcare Inc. was provided in the meeting materials.
Discussion
Supervising Inspector Janice Dang gave the board an overview of the report that was provided
in the meeting materials.
Dr. Castellblanch commented that the report reflected several violations and noted that he was
concerned about patient safety. Chairperson Veale provided that many of the violations in the
Minutes of July 30-31, 2013 Public Board Meeting
report were relatively minor and have since been corrected. Chairperson Veale asked Dr. Dang
if the locations would have been cited and fined for the violations she reported. Dr. Dang
responded that they would not.
Ms. Veale noted that the committee was disappointed that a pharmacist was not included in
the accreditation process by DNV.
Dr. Gutierrez added that while the violations noted were minor they should not be ignored.
Dr. Gutierrez asked the representative from DNV if they require full compliance with USP 797.
Troy McCan, from DNV, responded that DNV does not.
Ms. Herold added that the board has the capability to issue a cease and desist to a sterile
compounding pharmacy if the board finds significant violations that put the public’s health at
risk.
Dr. Gutierrez asked to clarify if the motion was to extend DNV’s accreditation for one year. Mr.
Brooks responded that the motion was to extend it, however extending it does not impede the
board’s ability to go into the sites and inspect them.
Chairperson Veale reported that DNV’s original request was to extend their accreditation for
three years. However the committee feels pending legislation (SB 294) will pass that will require
the sites to become licensed with the board making the three year extension unnecessary.
Dr. Castellblanch expressed his opinion that until a bill is signed they should not count on it
passing. Chairperson Veale responded that if SB 294 does not pass then in one year DNV will
have to come back to the board for approval. Additionally if it does not pass the board will
make changes to the requirements for the accreditation process to address the current
problems. Ms. Herold added that the board has a regulation they are holding back until they
know the outcome of SB 294, that will clearly define the requirements for becoming board
approved accreditation agency.
Committee Motion: One-year approval of DNV accreditation. Along with this approval the
board will send a letter requesting inclusion of the elements the board requires: adding a
pharmacist to the survey team, providing information to the board, and updating the board
when the deficiencies have been corrected.
Support: 8 Oppose: 2 (Gutierrez and Castellblanch) Abstain: 1 (Lippe)
quoted from here
Pharmacy Approval as an Accreditation Agency for Licensed Sterile Injectable
Compounding Pharmacies
Relevant Statutes
Business and Professions Code Sections 4127 – 4127.8 provides for the regulation of
pharmacies that compound sterile injectable drug products in a pharmacy. Pharmacy law
creates an exemption from the licensure requirements for a pharmacy that is accredited by a
private accreditation agency approved by the board (B&PC 4127.1 (d) and 4127.2 (c).
Background
For the past several years the board has been discussing several elements of pharmacies that
compound sterile injectable products, including the requirements for private accreditation
agencies. As part of the current approval process, such agencies apply to the board for
consideration and approval by the board.
Det Norske Veritas (DNV) was previously approved by the board for a three year period. This
approval will expire later this year. As such DNV has submitted a new request to the board.
Regrettably because the April Licensing Committee meeting was rescheduled, a representative
from DNV was unable to attend the committee meeting. The committee recommended to the
board to extend DNV’s approval for three months so that DNV would be able to attend the May
Licensing Committee meeting. The board approved this recommendation.
Supervising Inspector Janice Dang conducted an inspection of four hospitals accredited by DNV.
This summary was provided as part of the meeting materials.
The committee discussed the summary of inspections for the four hospitals accredited by DNV
inspected by Supervising Inspector Janice Dang. DNV was not present at the Licensing
Committee meeting. Chair Veale advised the committee of pending legislation SB 294
(Emerson) that if approved, will supersede accrediting approval by the board. Chair Veale
indicated if the bill fails, accreditation in lieu of licensure will be allowed.
A summary of hospital pharmacy initial and follow up inspections of hospital accredited by Det
Norske Veritas Healthcare Inc. was provided in the meeting materials.
Discussion
Supervising Inspector Janice Dang gave the board an overview of the report that was provided
in the meeting materials.
Dr. Castellblanch commented that the report reflected several violations and noted that he was
concerned about patient safety. Chairperson Veale provided that many of the violations in the
Minutes of July 30-31, 2013 Public Board Meeting
report were relatively minor and have since been corrected. Chairperson Veale asked Dr. Dang
if the locations would have been cited and fined for the violations she reported. Dr. Dang
responded that they would not.
Ms. Veale noted that the committee was disappointed that a pharmacist was not included in
the accreditation process by DNV.
Dr. Gutierrez added that while the violations noted were minor they should not be ignored.
Dr. Gutierrez asked the representative from DNV if they require full compliance with USP 797.
Troy McCan, from DNV, responded that DNV does not.
Ms. Herold added that the board has the capability to issue a cease and desist to a sterile
compounding pharmacy if the board finds significant violations that put the public’s health at
risk.
Dr. Gutierrez asked to clarify if the motion was to extend DNV’s accreditation for one year. Mr.
Brooks responded that the motion was to extend it, however extending it does not impede the
board’s ability to go into the sites and inspect them.
Chairperson Veale reported that DNV’s original request was to extend their accreditation for
three years. However the committee feels pending legislation (SB 294) will pass that will require
the sites to become licensed with the board making the three year extension unnecessary.
Dr. Castellblanch expressed his opinion that until a bill is signed they should not count on it
passing. Chairperson Veale responded that if SB 294 does not pass then in one year DNV will
have to come back to the board for approval. Additionally if it does not pass the board will
make changes to the requirements for the accreditation process to address the current
problems. Ms. Herold added that the board has a regulation they are holding back until they
know the outcome of SB 294, that will clearly define the requirements for becoming board
approved accreditation agency.
Committee Motion: One-year approval of DNV accreditation. Along with this approval the
board will send a letter requesting inclusion of the elements the board requires: adding a
pharmacist to the survey team, providing information to the board, and updating the board
when the deficiencies have been corrected.
Support: 8 Oppose: 2 (Gutierrez and Castellblanch) Abstain: 1 (Lippe)
quoted from here
1 comment:
SB 294 is protective, particularly for sterile to sterile compounding. It is not protective, however, with respect to API non-sterile to sterile compounding.
The link between the NECC pharmacy and most all compounding pharmacies across the nation is a misplaced trust and reliance on chemical formulas purchased from compounding suppliers, given that the sellers or publishers are generally disclaimed of liability resulting from their use. The formulas contain ingredients taken out of context of the complicated issues that arise and that are mitigated during drug development and approval. NECC-like risks exist in all pharmacies where formulas are utilized "as if" they had been subjected to the rigors of the drug approval process, when in fact critical regulatory, clinical and pharmaceutical science have been set aside. Further complicating the issue but addressed to certain extent in 294, traditional compounding pharmacies escape surveillance and reporting requirements for drugs they make. Given the challenges with identifying drug induced illness even where reporting does occur, any comparative claim regarding the safety or efficacy of compounded drugs should be taken with great skepticism. Boards of Pharmacy, and any entity standing in for the Boards, should be asking, do pharmacies know what they don't know about the formulas they are relying on or are they also disclaiming any liability regarding safety, efficacy, and manufacturing quality?
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