Monday, April 29, 2013
Sunday, April 28, 2013
Question of the Day 4/28/2013 Is the FDA's and some states' Position on Bulk Compounding for Animals Unsound?
There are a number of reasons the FDA's position appears to be unsound in that in some cases in non-food producing animals it is medically necessary. It can be medically necessary when:
FDA-approved product is not commercially available,
FDA-approved drug is available but the needed compound cannot be prepared from it, or
The needed drug is not in an FDA-approved, commercially available form.
Fix 'compounding pharmacy' oversight: Our view
he first time most people heard of a "compounding pharmacy" was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.
ANOTHER VIEW: We're dedicated to patients' health
Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreaktied to tainted injections made by the New England Compounding Center (NECC).
More than 700 people in 20 states have been sickened, and many are still suffering.
In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?
The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency's authority does need to be clarified and expanded.
For more than a century, traditional compounders have provided a vital service, mixing prescriptions for individual patients who need something customized, such as a liquid for someone who can't swallow pills. By the late 1990s, however, some compounders envisioned big profits in making large batches of medicine and selling to clinics and hospitals all over the country — essentially acting like manufacturers.
The lethal problems range far beyond NECC. In recent inspections, the FDA found dozens of safety problems at large-scale compounders across the USA — from black particles in injectable medicines to rust and mold in supposedly sterile rooms. In a survey, Rep. Edward Markey, D-Mass., said he found compounders going "untracked, unregulated and underinspected" by states.
At the now-shuttered New England Compounding Center, the FDA and Massachusetts health officials knew of problems with company products, including the same medication suspected in the recent deaths, as far back as 2006. But aside from a pair of warnings, little action was taken until people started dying.
This month, FDA Commissioner Margaret Hamburg acknowledged to a House committee that her agency "should have more aggressively applied existing authorities." Last week, she told the USA TODAY Editorial Board that oversight of compounders is at "a critical moment" and that "the system is broken." Large-scale compounders, she said, should have to register with the FDA, meet uniform quality standards, label their products, report any adverse drug reactions and be barred from producing certain medications.
All that makes sense, and on Friday a bipartisan group of senators proposed a measure to reach those goals. But any new law faces hurdles, particularly from House Republicans who are so bent on blaming the FDA that they oppose providing the clarity and tools to ensure public safety.
Twice in the past decade, the Senate looked into mounting problems with compounders. After the International Academy of Compounding Pharmacists, the industry's trade group, opposed proposed solutions, Congress did nothing. A spokesman for the group says its leadership has changed, and it wants to work with the Senate. We'll see what happens this time, now that the deadly consequences of inaction are clear
Quoted from THE USAToday
State of Washington Board of Pharmacy Clarifies Pharmacy Compounding Standards
No. 1135 Clarification of Pharmacy
Compounding Standards
The Washington State Board of Pharmacy discussed pharmacy
compounding standards at the February 21, 2013 business
meeting, specifically WAC 246-878-020(4). The Board has
always read Section (4) in conjunction with other subsections
that specifically require a prescription for a compounded
drug. However, it agreed that Section (4), read independently,
could allow a pharmacy to provide compounded products for
a practitioner to give out to individual patients without a prescription
for a specific patient. Because this has clearly been
the belief of some compounding pharmacies in Washington,
the Board decided it will honor this interpretation of the rule.
On January 10, 2013, the Board authorized rulemaking regarding
compounding practices to ensure appropriate standards
are in place to protect the health and safety of the people of
Washington. The Board will invite stakeholders to participate
after filing the “Intent to Initiate Rulemaking” (CR101).
Quoted from State of Washington Board of Pharmacy April 2013 Newsletter
South Dakota Board of Pharmacy Distinction Between Compounding and Manufacturing
Compounding and Manufacturing
Over the last several months, there have been numerous
communications as to the definition of compounding
versus manufacturing. South Dakota Codified Law 36-
11-2(5) defines compounding “as the preparation, mixing,
assembling, packaging or labeling of a drug or drug
device as a result of a practitioner’s prescription drug
order or an initiative based on the pharmacist/patient/
practitioner relationship in the course of professional
practice,” eg, patient-specific. Manufacturing on the
other hand, as defined by the National Association of
Boards of Pharmacy® is “preparation of non-patient specific
products where the primary focus is on the product;
not the patient.” Organizations that are manufacturing
must be permitted by Food and Drug Administration.
Quoted from South Dakota Board of Pharmacy April 2013 Newsletter
North Carolina Board of Pharmacy--Compounding Working Group Report Likely to Be Presented in Spring
Item 2259 – Further Update on
Pharmacy Compounding Matters
Item 2252 of the January 2013 Newsletter updated
North Carolina pharmacists on compounding regulation
matters arising as a result of the New England Compounding
Center tragedy. The Pharmacy Compounding
Working Group has proceeded with its charge to make a
report and recommendation to the Board on any needed
regulatory changes (whether statutory, rule-based,
training-based, or resource-based). That report and
recommendation is likely to be presented to the Board
this spring.
There continues to be discussion and debate at the
federal level about the need for amendments to the
federal Food, Drug, and Cosmetic Act to shift, clarify,
or both, the line between prescription drug compounding
(regulated at the state level by boards of pharmacy)
and prescription drug manufacturing (regulated at the
federal level by Food and Drug Administration (FDA)).
Board staff participated in an intergovernmental conference
hosted by FDA in late December 2012, where
multiple issues were discussed among federal and state
regulators. Indications are that federal legislation will
be introduced this spring. Board staff will update North
Carolina pharmacists on any developments.
Quoted from the North Carolina Board of Pharmacy April 2013 Newsletter
LA Board of Pharmacy Disciplinary Action for 2012-13 (several re: compounding)
Disciplinary Actions (13-04-431)
During its December 2012 meeting, the Board took final action in the following matters:
David Collins Evans (PST.01481): Accepted voluntary sur- render, resulting in suspension of the license for an indefinite period of time, effective August 27, 2012.
Nancy Lynn Odom (PST.014796): Accepted voluntary sur- render, resulting in suspension of the license for an indefinite period of time, effective September 21, 2012.
Steve John Soteropulos (PST.011704): Accepted voluntary surrender, resulting in suspension of the license for an in- definite period of time, effective November 5, 2012.
Nicholas Matthew Bullard (PNT.046745): Accepted volun- tary surrender, resulting in suspension of the registration for an indefinite period of time, effective November 30, 2012.
Michael Wayne Lindsey (PST.015624): Granted request for reinstatement of the previously suspended license, convert- ed the suspensive period from an indefinite term to a term of 10 years and stayed the execution of the suspension, and then placed the license on probation for 10 years, effective December 12, 2012, subject to certain terms enumerated in the consent agreement.
Michael Scott Gallotte (PST.020036): Authorized the issuance of license by reciprocity on January 1, 2013, suspended the newly issued license for a period of time ending November 18, 2019, and stayed the execution of the suspension, and then placed the license on probation for the entire suspensive period, subject to certain terms enumerated in the consent agreement.
Northlake Pharmacy (PHY.006184): Revoked the permit; for five counts, including failure to properly close pharmacy and dispose of patient prescription records.
Michael Roger Chamberlain (PST.014768): Issued letter of reprimand and assessed a fine of $1,000 plus costs; for seven counts, including failure to properly close Northlake Pharmacy.
Steven’s Pharmacy (PHY.004535 and CDS.038660): Suspended the permits for five years and stayed the execution thereof, and then placed the permits on probation for five years, effective October 1, 2012, subject to certain terms enumerated in the consent agreement, and further, assessed a fine of $10,000 plus costs; for eight counts, including failure to report theft or loss of controlled substances (CS) and accountability for shortages of CS.
Steven Walter Gough (PST.013199): Suspended the license for five years and stayed the execution thereof, and then placed the license on probation for five years, effective October 1, 2012, subject to certain terms enumerated in the consent agreement, and further, assessed a fine of $5,000 plus costs; for eight counts, including failure to report theft or loss of CS as well as accountability for shortages of CS as pharmacist-in-charge (PIC) of Steven’s Pharmacy.
Danna Marie Harris (CPT.010899): Issued letter of reprimand, and further, assessed costs; for six counts, including continuing to practice with an expired credential.
Walgreens Pharmacy No. 11413 (PHY.005926): Assessed a fine of $1,000 plus costs; for seven counts, including al- lowing multiple pharmacists to administer immunizations without the proper credentials to do so.
Emile Henry Clay III (PST.017461): Issued letter of repri- mand, and further, assessed a fine of $500 plus costs; for seven counts, including administration of immunizations without the proper credentials from the Board to do so.
Emma Osiris Dolmo (PST.017273): Issued letter of repri- mand, and further, assessed a fine of $250 plus costs; for seven counts, including administration of immunizations without the proper credentials from the Board to do so.
Village Pharmacy of Port Vincent (PHY.006278 and CDS.039387): Revoked the permit, and further, perma- nently prohibited the acceptance of any future application for the reinstatement of the permit, and further, assessed investigative costs; for 17 counts, including dispensing fraudulent prescriptions for CS, failure to exercise corresponding responsibility for dispensing prescriptions for CS, failure to comply with reporting requirements for the Louisiana Prescription Monitoring Program, and failure to maintain accurate prescription records for CS.
Kirkland Daniel Jeane (PST.018892): Revoked the license, and further, permanently prohibited the acceptance of any future application for the reinstatement of the license, and further, permanently prohibited any ownership interest in any pharmacy licensed by the Board; for 22 counts, as owner and PIC of Village Pharmacy of Port Vincent.
Stacy Shields Corcoran (CPT.005104): Revoked the certificate, and further, permanently prohibited any future appli- cation for reinstatement of the certificate or for any other credential issued by the Board; for five counts, including diversion of CS from her employer pharmacy.
Shaasta Monique Moore (CPT.009526): Revoked the certificate, and further, permanently prohibited any future application for reinstatement of the certificate or for any other credential issued by the Board; for five counts, includ- ing the acceptance of forged prescriptions at her employer pharmacy.
Melisa Ann Cowan (CPT.004438): Revoked the certificate, and further, permanently prohibited any future applica- tion for reinstatement of the certificate or for any other credential issued by the Board; for five counts, including diversion of CS from her employer pharmacy.
Robert Joseph Gaspard, Jr (PTC.017871): Revoked the registration, and further, permanently prohibited any future application for reinstatement of the registration or for any other credential issued by the Board; for five counts, including diversion of CS from his employer pharmacy.
Franck’s Compounding Pharmacy (PHY.005484): Ac-cepted voluntary surrender of the credential, resulting in active suspension of the pharmacy permit for an indefinite period of time, effective August 31, 2012.
Paul Ryan Lemaire (PST.018503): Accepted voluntary surrender of the credential, resulting in active suspension of the license for an indefinite period of time, effective October 15, 2012.
New England Compounding Center (PHY.005145): Accepted voluntary surrender of the credential, resulting in active suspension of the pharmacy permit for an indefinite period of time, effective October 29, 2012.
Barry James Cadden (PST.017479): Accepted voluntary surrender of the credential, resulting in active suspension of the license for an indefinite period of time, effective
December 3, 2012.
Ginger Marisa Greenwood (SWP.000222): Accepted voluntary
surrender of the credential, resulting in active suspension
of the special work permit for an indefinite period of
time, effective December 12, 2012.
During the same meeting, the Board granted approval of
four petitions for modification of previous orders from three
pharmacists and one pharmacy intern. The Board also granted
approval of reinstatement applications for lapsed credentials
for one pharmacist and two technicians contingent upon the
satisfaction of certain terms in the consent agreement, and
for one technician with no further action required. The Board
also issued a letter of warning to one pharmacy and a letter
of reprimand to one pharmacy technician. Finally, the Board
suspended the controlled dangerous substance (CDS) licenses
for four physicians and one physician assistant whose medical
licenses were suspended by the Louisiana State Board of Medical
Examiners as well as for one physician who had surrendered
his Drug Enforcement Administration registration.
During its March 2013 meeting, the Board took final action
in the following matters:
Kerry Michael Finney (PST.013535): Granted request for reinstatement
of the previously suspended license, converted
the suspensive period from an indefinite term to a term of
15 years and stayed the execution of the suspension, and
then placed the license on probation for 15 years, effective
March 6, 2013, subject to certain terms enumerated in the
consent agreement.
Wade Randall Veillon (PST.011709): Granted request for reinstatement
of the previously suspended license, converted
the suspensive period from an indefinite term to a term of
15 years and stayed the execution of the suspension, and
then placed the license on probation for 15 years, effective
March 6, 2013, subject to certain terms enumerated in the
consent agreement.
Steve John Soteropulos (PST.011704): Granted request for
reinstatement of the previously suspended license, converted
the suspensive period from an indefinite term to a
term of 15 years and stayed the execution of the suspension,
and then placed the license on probation for 15 years, effective
March 6, 2013, subject to certain terms enumerated
in the consent agreement.
Roger Thi Ly (PST Applicant): Denied application for
licensure by reciprocity and refused to issue the license
for disciplinary action in another jurisdiction.
Derek Anthony Sapone (PST Applicant): Denied application
for licensure by reciprocity and refused to issue the license
for failure to declare prior history.
David Allen Guillory (PST.015750): Suspended license
for 54 months and stayed the execution thereof, and then
placed the license on probation for 54 months, effective
March 6, 2013, subject to certain terms enumerated in the
consent agreement.
CVS Pharmacy No. 5349 (PHY.005943): Assessed a fine
of $25,000 plus costs; for five counts, including allowing
a technician candidate to work with an expired registration
for four months.
Madisonville Compounding, LLC, dba The Compounding
Corner (PHY.006070 and CDS.039279): Suspended both
credentials for one year and stayed the execution thereof,
and then placed both credentials on probation for one year,
effective January 1, 2013, subject to certain terms enumerated
in the consent agreement, and further, assessed a fine
of $5,000 plus costs; for seven counts, including distribution
of samples to physicians for further resale.
LA Has a New Compliance Officer
New Compliance Officer (13-04-430)
The Board is pleased to announce the appointment of a new pharmacist compliance officer, effective April 8. Carey D. Aaron completed his pharmacy education at the Northeast Louisiana University School of Pharmacy (now University of Louisiana at Monroe College of Pharmacy) in 1995, and has accumulated over 15 years of experience in community phar- macy practice. Mr Aaron resides in the Shreveport, LA, area and will be responsible for inspecting pharmacies and other facilities in the northwestern part of the state.
quoted from source found here
The Board is pleased to announce the appointment of a new pharmacist compliance officer, effective April 8. Carey D. Aaron completed his pharmacy education at the Northeast Louisiana University School of Pharmacy (now University of Louisiana at Monroe College of Pharmacy) in 1995, and has accumulated over 15 years of experience in community phar- macy practice. Mr Aaron resides in the Shreveport, LA, area and will be responsible for inspecting pharmacies and other facilities in the northwestern part of the state.
quoted from source found here
LA Promulgated Several New Rules in Feb. and Mar. 2013
New Rules (13-04-429)
The Board completed the promulgation process for several new rules in February and March. More information about these new rules can be found on the Board’s Web site. The 2013 update for the Louisiana Pharmacy Law Book is scheduled for publication before the end of April.
♦ Regulatory Project 2012-5 ~ Institutional Pharmacies: Effective February 20
♦ Regulatory Project 2012-6 ~ Interstate Remote Process- ing: Effective February 20
♦ Regulatory Project 2012-7 ~ Security of Prescription Department: Effective February 20
♦ Regulatory Project 2012-8 ~ CDS License for Non- resident Distributor: Effective February 20
♦ Regulatory Project 2012-9 ~ CDS in Emergency Drug Kits: Effective February 20
♦ Regulatory Project 2012-10 ~ Prescription Monitoring Program: Effective February 20
♦ Regulatory Project 2012-11 ~ Durable Medical Equip- ment: Effective March 20
quoted from source found here
The Board completed the promulgation process for several new rules in February and March. More information about these new rules can be found on the Board’s Web site. The 2013 update for the Louisiana Pharmacy Law Book is scheduled for publication before the end of April.
♦ Regulatory Project 2012-5 ~ Institutional Pharmacies: Effective February 20
♦ Regulatory Project 2012-6 ~ Interstate Remote Process- ing: Effective February 20
♦ Regulatory Project 2012-7 ~ Security of Prescription Department: Effective February 20
♦ Regulatory Project 2012-8 ~ CDS License for Non- resident Distributor: Effective February 20
♦ Regulatory Project 2012-9 ~ CDS in Emergency Drug Kits: Effective February 20
♦ Regulatory Project 2012-10 ~ Prescription Monitoring Program: Effective February 20
♦ Regulatory Project 2012-11 ~ Durable Medical Equip- ment: Effective March 20
quoted from source found here
Arkansas Compounding Pharmacy Inspections and Reminders
In response to the recent
outbreak of fungal meningitis due to the inappropriate
compounding of products,
the Arkansas State Board of
Pharmacy reminded licensees of its inspection requirements. The Board has completed regular inspections
of its pharmacies for years
and it makes every effort to
inspect each one at least once
annually. The Board’s review
of the 2012 inspections
shows that 667 of the 748
pharmacies in Arkansas were
inspected between January 1 and December 7. This
number does not include additional site visits for changes
of location, new openings, or
the multiple visits and walk-
throughs that the Board con-
ducts routinely for its major
compounding pharmacies.
All of the Board’s pharmacy
inspectors, as well as executive and assistant directors,
are licensed pharmacists
with experience and expertise in various areas of pharmacy practice. Board staff
has sought out and received
training in United States
Pharmacopeia standards
such as Chapter 797 and has
incorporated sterile com-
pounding inspection surveys
into the Board’s workflow
for any pharmacies that are
preparing sterile products.
While the Board does not
claim this to be an absolute
safety net, the Board continues to pursue additional
opportunities for training
and learning opportunities
to continually improve it efforts in inspecting com-
pounding pharmacies.
The Board notes that any
pharmacies that are prepar-
ing compounded products
for distribution in or into
Arkansas, should review
Regulation 07-02: COM-
POUNDING, pertaining to
pharmacy compounding,
which details Board require-
ments for sterility, potency,
and endotoxin testing that
must be followed prior to
dispensing or administration
of products.
Quoted from source found here
Quoted from source found here
109th Annual NABP Meeting--Compounding/Manufacturing Debate: When Is a Duck Not A Duck?
May 18-21, 2013
Saturday, May 18, 2013
9 am - 7 pm
Registration/Information Desk Open
2 - 4 pm
Pre-Meeting CPE
The Compounding/Manufacturing Debate: When Is a Duck Not a Duck? ACPE #205-000-13-001-L03-P
(0.2 CEUs – 2 contact hours)
5 - 6 pm
Annual Meeting and District Meeting Orientation
7 - 10 pm
President’s Welcome Reception
Sponsored by Express Scripts Honoring NABP President Michael A. Burleson, RPh Dinner will be served
Dress: business casual
Sunday, May 19, 2013
Institute of Medicine Cites VAWD and VIPPS in Recommended Actions for Fighting Substandard Drugs in the US and Globally
Substandard and falsified medications have led
to thousands of cases of illness, injury, and death around the world, includ- ing the recent cases in the United States involving the distribution of a contaminated compounded inject- able drug to pain clinics and hospitals in 19 states, and the distribution of
fake cancer medication to numerous clinics around the country. Regulators tackling the problem – both in the US and abroad – face challenges including the complexity of the global pharmaceutical distribution chain and varied standards, regulations, and enforcement efforts.
continue to read here
to thousands of cases of illness, injury, and death around the world, includ- ing the recent cases in the United States involving the distribution of a contaminated compounded inject- able drug to pain clinics and hospitals in 19 states, and the distribution of
fake cancer medication to numerous clinics around the country. Regulators tackling the problem – both in the US and abroad – face challenges including the complexity of the global pharmaceutical distribution chain and varied standards, regulations, and enforcement efforts.
continue to read here
Iowa Compounding Inspection Program Progresses With Member Support
Iowa Inspection
Program Ongoing
In late 2012, the Iowa
Board of Pharmacy partnered with other states
and NABP to conduct inspections of all nonresident pharmacies includ- ing those believed to be delivering compounded drugs into the state. Ongo- ing surveys are focused on inspecting all nonresident pharmacies shipping into the state of Iowa for the purpose of facilitating licensure and to confirm that all pharmacies provid- ing product and services
to patients in Iowa, in particular those entities engaging in sterile or other drug compounding, are doing so in a safe and legal manner.
and NABP to conduct inspections of all nonresident pharmacies includ- ing those believed to be delivering compounded drugs into the state. Ongo- ing surveys are focused on inspecting all nonresident pharmacies shipping into the state of Iowa for the purpose of facilitating licensure and to confirm that all pharmacies provid- ing product and services
to patients in Iowa, in particular those entities engaging in sterile or other drug compounding, are doing so in a safe and legal manner.
Under the contract
with the Iowa Board, since mid-December, NABP surveyors have completed inspections of 100 pharmacies in nine states. Inspections are ongoing across the nation and as such are not consigned to any one state. On average, NABP surveyors complete 15 to 20 inspections a week, with reports submitted directly to the Iowa Board.
with the Iowa Board, since mid-December, NABP surveyors have completed inspections of 100 pharmacies in nine states. Inspections are ongoing across the nation and as such are not consigned to any one state. On average, NABP surveyors complete 15 to 20 inspections a week, with reports submitted directly to the Iowa Board.
NABP works in part-
nership with the boards
of pharmacy in each state, and in several states board inspectors have accompa- nied NABP surveyors on inspections.
Aggregate data reports with relevant survey findings, along with Surveyor Scoring Reports are disseminated to the Iowa Board of Pharmacy on a weekly basis. Initial results of the inspections include a wide range of observations on the entities inspected
to date. For example, when visiting some sites, surveyors discovered that the facilities ceased compounding activity in late 2012. In a few instances, the address of the company was no longer valid, and it must
be determined whether
the entity moved, or is no longer in operation, and whether they notified the home or nonresident states in which they hold licenses. Some facilities had voluntarily surrendered their Iowa license prior
to the date of inspection but their products are still being used in Iowa, and some indicated they main- tained Iowa licensure only as part of the company’s contingency planning,
and were not distributing or dispensing drugs into the state. In those cases an inspection is done because distribution to Iowa can occur at any time. Other initial observations for the Iowa Board include documentation that some pharmacies are distributing sterile or other compounded drugs for office use, and some are using central fill processing for sterile and non-sterile compounded drugs.
of pharmacy in each state, and in several states board inspectors have accompa- nied NABP surveyors on inspections.
Aggregate data reports with relevant survey findings, along with Surveyor Scoring Reports are disseminated to the Iowa Board of Pharmacy on a weekly basis. Initial results of the inspections include a wide range of observations on the entities inspected
to date. For example, when visiting some sites, surveyors discovered that the facilities ceased compounding activity in late 2012. In a few instances, the address of the company was no longer valid, and it must
be determined whether
the entity moved, or is no longer in operation, and whether they notified the home or nonresident states in which they hold licenses. Some facilities had voluntarily surrendered their Iowa license prior
to the date of inspection but their products are still being used in Iowa, and some indicated they main- tained Iowa licensure only as part of the company’s contingency planning,
and were not distributing or dispensing drugs into the state. In those cases an inspection is done because distribution to Iowa can occur at any time. Other initial observations for the Iowa Board include documentation that some pharmacies are distributing sterile or other compounded drugs for office use, and some are using central fill processing for sterile and non-sterile compounded drugs.
Additional information
about the Iowa inspection program results will
be presented at the NABP
109th Annual Meeting, May
18-21, 2013, in St Louis,
MO, and will also be
included in future issues of
the NABP Newsletter..
Quoted from the National Board of Pharmacy May 2013 Newsletter
Quoted from the National Board of Pharmacy May 2013 Newsletter
Interesting Discussion At March 2013 Utah State Board of Pharmacy Meeting Regarding Compounding
Mr. Steinagel met with the Board and reviewed the
Division’s response to recommendations made by the
Compounding Task Force.
The task force recommends that the Division enforce an inspection moratorium on compounding
pharmacies. The Division is uncomfortable with this
idea. The Division cannot cease issuing citations and
disciplining compounding pharmacies.
The task force recommends that DOPL investigators
and inspectors go through training on federal laws that
regulate the pharmacy profession. The Division
supports this idea and is willing to provide additional
training for investigators. Five investigators will go
through intensive NABP training in May that was
scheduled before the task force met to discuss
recommendations.
The task force encourages inspectors to educate licensees when they investigate them and follow-up on inspections. The Division supports this idea.
The task force recommends updating of the compounding self-inspection report. The Division agrees with this idea and will consult with Board members and others in the field as necessary as updates to the report are made. The Division will make updates to the report and submit a revised self- inspection report to the Board for review at the May meeting.
The task force recommends creation of self- inspection reports for Class B and C pharmacies. The Division is working on this.
The task force recommends that the Pharmacy Practice Act be revised. The Division is happy to provide input to Board members, legislators, and associations as they propose amendments to the Act. The Board will be discussing possible amendments to the Act during future Board meetings.
The task force recommends that standards regarding transferring compounds within the same institutional setting be clarified and that language in regard to manufacturing vs. traditional vs. non-traditional compounding be clarified. The Division is willing to work with the Board on these items.
The task force encourages inspectors to educate licensees when they investigate them and follow-up on inspections. The Division supports this idea.
The task force recommends updating of the compounding self-inspection report. The Division agrees with this idea and will consult with Board members and others in the field as necessary as updates to the report are made. The Division will make updates to the report and submit a revised self- inspection report to the Board for review at the May meeting.
The task force recommends creation of self- inspection reports for Class B and C pharmacies. The Division is working on this.
The task force recommends that the Pharmacy Practice Act be revised. The Division is happy to provide input to Board members, legislators, and associations as they propose amendments to the Act. The Board will be discussing possible amendments to the Act during future Board meetings.
The task force recommends that standards regarding transferring compounds within the same institutional setting be clarified and that language in regard to manufacturing vs. traditional vs. non-traditional compounding be clarified. The Division is willing to work with the Board on these items.
The task force recommends that DOPL send a letter to compounding pharmacies. A letter was sent last year
and the Division is willing to consider sending a
second one this year.
The task force recommends that network-network-
network become compliant with USP standards. This
is something the Division agrees that the industry can
work on.
Mr. Steinagel advised the Board that DOPL is interested in inviting NABP to come to Utah to make training available to representatives of pharmacies in Utah that engage in compounding. This training is three or four days and is very intensive. Mr. Steinagel advised the Board that it would require legislation to amend the laws upon which the inspection report is based.
The Board expressed concern regarding sending sterilized compounding out of state. Mr. Steinagel noted that currently pharmacies are self reporting to DOPL and encouraged the Board to consider the following options: (1) Creation of licensure for compounding pharmacy; (2) Require pharmacies to declare whether they do sterile compounding; (3) During renewal, have the pharmacy representative affirm whether they are engaging in sterile compounding. The Board will discuss this at a future meeting.
Quoted from Utah Board of Pharmacy March 3, 2013 minutes
Mr. Steinagel advised the Board that DOPL is interested in inviting NABP to come to Utah to make training available to representatives of pharmacies in Utah that engage in compounding. This training is three or four days and is very intensive. Mr. Steinagel advised the Board that it would require legislation to amend the laws upon which the inspection report is based.
The Board expressed concern regarding sending sterilized compounding out of state. Mr. Steinagel noted that currently pharmacies are self reporting to DOPL and encouraged the Board to consider the following options: (1) Creation of licensure for compounding pharmacy; (2) Require pharmacies to declare whether they do sterile compounding; (3) During renewal, have the pharmacy representative affirm whether they are engaging in sterile compounding. The Board will discuss this at a future meeting.
Quoted from Utah Board of Pharmacy March 3, 2013 minutes
State Inspector Recommends to Vermont Board of Pharmecy that it Make USP 797 Standard for All Compounding Pharmacies to Follow
Compounding Pharmacy Rules – Inspector Vincent spoke to the Board about the issues he sees when inspecting. He feels our Rules do not adequately address sterile compounding and suggested the Board consider making USP 797 the standard for all compounding pharmacies to follow. Ms. Eaton suggested making a small committee, possibly two Board members with counsel and Mr. Klein, to discuss the adoption of USP 797 and refining the institutional pharmacy regulations.
Source found at http://vtprofessionals.org/opr1/pharmacists/minutes_agenda/Pharmacy_Minutes_2013_0327.
Source found at http://vtprofessionals.org/opr1/pharmacists/minutes_agenda/Pharmacy_Minutes_2013_0327.
Drug Traceability Drafts Reflect Progress, Supply Chain Stakeholders Say
(Daily News - 04-26-2013)
CHICAGO -- The majority of supply chain stakeholders believe all sectors of industry should be subject to federal standards under a drug traceability system, according to a survey by the Pew Charitable Trusts that emerges as members of Congress prepared to debate the development of a drug track and trace system, including potential exemptions and considerations for small pharmacies.
subscription required
Meningitis spreads to finger-pointing
Apr. 27, 2013 10:19 PM Livingston County is all but the epicenter of the meningitis cases that have grown out of the scandal originating at a large-scale — and woefully unregulated — compounding pharmacy in Massachusetts. continue reading here
Saturday, April 27, 2013
The Chronicle of the Horse Has Interesting Discussion On-going Regarding Vets Liability or Compounded Medications
To read and follow this discussion click here
$15,000 Annual Fee for Compounding Manufacturers Could Net FDA $45 Million for Inspections
“No Compounding Allowed” Drugs Would Be Established Under Senate Draft Bill
Word Count: 1080 / Article # 14130426008 / Posted: April 26 2013 6:55 PM
Executive Summary
A $15,000 annual establishment fee for “compounding manufacturers” could net FDA $45 million for inspecting those compounding sites.
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Question of the Day: 4/27/13 Isn't IACP in fact correct that this bill will cause more confusion and blur the jurisdictional line?
IACP 'think[s] the term “compounding manufacturer” and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators." Isn't IACP in fact correct that this bill will cause more confusion and blur the jurisdictional line? Won't this bill in fact cause more court litigation over these definitions, the jurisdiction and who in fact fits within these definitions and falls under the FDA's jurisdiction?
IACP's Statement Regarding Draft Federal Legislation
U.S. Senate HELP Committee Releases Draft Compounding Bill
IACP just today received a copy of the draft bill and we are still reviewing it. We applaud the steps the Committee and the U.S. Senate are taking to ensure that compounded medications are as safe as they can be. IACP believes that the safety of patients must always be the first consideration of any pharmacy-oriented public policy.
From our preliminary review of that draft, we see that there are some aspects of the draft that will need further discussion and refinement, and we intend to work with the Committee on these. The draft does not contain any provisions that speak directly to standards aimed at raising the quality of compounded medications. Additionally, IACP is concerned that some provisions may reduce patient and physician access to customized medications, the very services that compounding pharmacists provide.
IACP reiterates its position that state boards of pharmacy are responsible for the licensing and oversight of compounding pharmacies and the FDA is responsible for overseeing and regulating pharmaceutical manufacturers. We think the term “compounding manufacturer” and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators. IACP will recommend improvements in the draft language to make the proposed categories more clear.
Most importantly, IACP is gravely concerned that compounding pharmacies located in hospitals and health systems have been exempted from many of the proposed changes. Such an exemption denies patients and their families the assurance, regardless of where they receive their medications, of the quality and safety that they deserve.
We look forward to continuing to work with the House and Senate on refining this legislation.
Compounding Policy Update from AVMA
We want to thank our members who shared their input on the proposed revisions to the AVMA’s Compounding and Compounding from Unapproved (Bulk) Substances policies. We received some great input.
Getting member feedback on these policies is critical, because we recognize there’s a balance to be struck between the necessity to use FDA-approved drugs with known safety and efficacy, while also meeting your compounding needs and those of your patients. We all recognize that compounding is a critical tool for specific patients with special needs that can’t always be met by FDA-approved drugs.
Word has it that the Senate is drafting federal legislation that could be introduced very soon. Therefore, our volunteer governance groups are going to be working as quickly as possible to solidify the AVMA’s compounding policies so that we can use them to advocate on your behalf on Capitol Hill, in defense of your compounding needs.
Stay tuned, because we will need your help communicating AVMA’s policies to members of Congress when legislation is ultimately introduced. In the meantime, we have helpful compounding resources on our website, including a new PDFyou can review to find out if you’re following the current rules.
Quoted from Source found here
Subcommittee on Oversight and Investigations Committee on Energy and Commerce Letter to Chairman Tim Murphy from Henry Waxman With Numerous Supporting Documents Attached and Linked
April 11, 2013
The Honorable Tim Murphy
Chairman
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, D.C. 20515
Chairman
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, D.C. 20515
Dear Chairman Murphy:
Next week, the Subcommittee will be holding our second hearing into the deadly meningitis outbreak caused by contaminated injectable drugs from the New England Compounding Center (NECC). You have invited Margaret Hamburg, the Food and Drug Administration (FDA) Commissioner to testify at this hearing. We think you should also invite the head of the International Academy of Compounding Pharmacists (IACP), the national organization representing compounding pharmacists.
A key question for this hearing is why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs. At our November hearing, Commissioner Hamburg indicated that weak legislative authority, combined with a series of conflicting court decisions that caused uncertainty as to the validity of the authorizing statute itself, left the agency without adequate authority to act against drug compounders.[1]
IACP Briefing Provided to Congress on History and Status of Compounding for Animals
COMPOUNDING FOR ANIMALS
ISSUE BRIEFlNG
EXECUTIVE SUMMARY
Since its inception in 1930, FDA has allowed pharmacists to compound medications from bulk
active pharmaceutical in gredients (APIs) for non food an imal s, including companion, exotic, and
perfonnance animals.
However, in July 2003, FDA abruptly reversed this policy without any indication of the
reasoning or justification behind the substantial policy reversal. FDA's new prohibition on
compounding for non food animals will adversely affect the health and well-being of many pets
and will have broad repercussions on many small businesses.
IACP has repeatedly attempted to negotiate with FDA on these polici es. However, the Agency
remains unmoved. FDA sent infonnation to State Boards of Pharmacy in April 2004 announcing
the initiation of an inspection campaign against pharmacies that compound for animals.
Developments of this nature make this issue increasingly urgent for pharmacists and
veterinar ians who provide care for an imal patients.
NECESSITY OF VETERINARY COMPOUNDING
IACP strongly supports the rights of pharmacists to compound for non food animals from bulk
ingredients. Such compounding is part of the fundamental, historical practice ofphannacy and
necessary to preserve the health and well-being of many companion, exotic, and performance
animals. Ifphannacists are limited to using FDA-approved, commercially available drugs, many
animals will die, go untreated, or su ffer needlessly.
ISSUE BRIEFlNG
EXECUTIVE SUMMARY
Since its inception in 1930, FDA has allowed pharmacists to compound medications from bulk
active pharmaceutical in gredients (APIs) for non food an imal s, including companion, exotic, and
perfonnance animals.
However, in July 2003, FDA abruptly reversed this policy without any indication of the
reasoning or justification behind the substantial policy reversal. FDA's new prohibition on
compounding for non food animals will adversely affect the health and well-being of many pets
and will have broad repercussions on many small businesses.
IACP has repeatedly attempted to negotiate with FDA on these polici es. However, the Agency
remains unmoved. FDA sent infonnation to State Boards of Pharmacy in April 2004 announcing
the initiation of an inspection campaign against pharmacies that compound for animals.
Developments of this nature make this issue increasingly urgent for pharmacists and
veterinar ians who provide care for an imal patients.
NECESSITY OF VETERINARY COMPOUNDING
IACP strongly supports the rights of pharmacists to compound for non food animals from bulk
ingredients. Such compounding is part of the fundamental, historical practice ofphannacy and
necessary to preserve the health and well-being of many companion, exotic, and performance
animals. Ifphannacists are limited to using FDA-approved, commercially available drugs, many
animals will die, go untreated, or su ffer needlessly.
Oklahoma Veterinary Medical Board Veterinarian-Client-Patient-Relationship - VCPR FAQs
| Veterinarian-Client-Patient-Relationship - VCPR |  |  |
A certificate for display at your clinic regarding VCPR requirements is available - click here.
VCPR FAQs
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Q. What is a Veterinarian-Client-Patient Relationship (VCPR)?
A: While there are some differences in what is necessary to establish a valid VCPR for small animal medicine versus large animal medicine, the basic factors are the same: The veterinarian assumes responsibility for making medical judgments regarding the health of the animal based on a current thorough medical knowledge of the animal(s), such knowledge is gained by recently seeing or being personally acquainted with the keeping and care of the animal to the extent necessary to properly make appropriate medical decisions the veterinarian must keep readily accessible, written medical records of his/her knowledge and treatment of the animal with sufficient detail to clearly explain the initial exam and enable another veterinarian to take over treatment of the animal based on such records, the veterinarian must provide for some form of after care in case an emergency occurs after said care is provided; and the veterinarian's actions would conform to applicable federal law and regulations.
Q. What can happen when a valid VCPR doesn't exist?
A: Inappropriate prescription medications maybe given for undiagnosed or unrelated conditions;
Inappropriate dosages are given in unapproved locations;
Meat quality assurance guidelines are ignored;
A definitive diagnosis is never made; Evidence-based medicine is not practiced;
A food animal may go to slaughter with drug residue. ( A possible human safety issue caused by drug residue is the reason most, if not all new antibiotics are script drugs).
There are many variables or questions that must be considered or answered when establishing a valid VCPR, such as: Is your client a small animal owner; does the owner have a stocker/feeder cattle operation; or does the owner have a horse or horses for commercial reasons or for recreational use. If any one of the factors listed above is missing then a valid VCPR does not exist. If a veterinarian has any question about whether a valid VCPR exists, err on the side of caution and do not prescribe, dispense or administer drugs until a thorough medical exam is conducted. When dispensing medications for administration by an animal owner/client please be mindful of your client's ability to follow your instructions. The veterinarian must, can, or should weigh the relative risk of the medicine being properly administered to the patient as well as the risk of the medicine being diverted for improper use such as human consumption.
Any veterinarian prescribing, dispensing or administering medication to animals for which a valid VCPR does not exist is in violation of the Oklahoma Veterinary Practice Act.
Q. Why is a VCPR so important?
A: A valid VCPR involves a scientific/biological examination process, knowledge of pharmacology and experienced professional judgment exercised by a duly licensed veterinarian in deciding if, when and how medications are utilized for an animal. If you have a good working relationship with your veterinarian, he or she will be able to help, advise, and guide you in the use appropriate medications for your animal. By establishing this relationship, a veterinarian also gains a better understanding and working knowledge of your animal management practices. Therefore, your veterinarian can help you make medical judgments, assist you with withdrawal times in food animals, your recordkeeping system, and can provide “extra label” drug use when deemed necessary under special circumstances. (Some medications are dangerous and can compromise the patient's well-being). Seeking and following a qualified veterinarian's advice and supervision is highly recommended regarding drug use for animals, especially in any food animal.
Q. Does the veterinarian have the right to refuse to provide a prescription?
A: Prescribing, dispensing or administering prescription drugs to an animal is generally in the discretion of the treating veterinarian. However, the Board has consistently held that it is unprofessional conduct for a veterinarian to refuse to provide a prescription to a client if deemed medically necessary and the veterinarian would have dispensed the medication for use by the patient from their own clinic. In other words, if the medication is deemed necessary by the veterinarian for treatment of a patient, then said prescription may be either dispensed by the veterinarian or if the client requests a written prescription so that the prescription can be filled by an external pharmacy. This does not mean that the veterinarian is compelled to release a requested prescription to an animal owner when there are medical or safety reasons for not releasing it or they would not dispense the medication from their own practice. If the veterinarian dispenses narcotics/controlled substances they must report it to the State's Prescription Monitoring Program (PMP). The PMP reporting process provides continuity of information between practitioners, pharmacies, and state law enforcement to help prevent prescription drug diversion and misuse of drugs in the State. In accordance with the PMP process, controlled dangerous substances must be reported within 5 minutes of dispensing.
Also, an owner and veterinarian should keep in mind that it is considered unprofessional conduct by a veterinarian to prescribe, administer or dispense any veterinary prescription drug to or for an animal solely for training, show or racing purposes and not for a medically sound reason.
The Board's staff is available to address questions concerning a valid VCPR and can be reached at 405-524-9006.
Material quoted from here
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Friday, April 26, 2013
Summary of Dr. Hamburg's Comments at FDLI Conference
Dr. Hamburg Opens Up FDLI Conference – Cites Budget Situation - Once again, FDA Commissioner Margaret A. Hamburg opened up the FDLI Conference here in Washington this week with an address that provided a comprehensive look at current agency activities and priorities. She noted that the times are challenging, though the challenges traditionally faced by an agency with such a large mandate is “made all he more difficult as we seek to fulfill our mission with the added pressure of the ‘new austerity’.” She said that FDA stands to lose approximately 209 million dollars this fiscal year – with $126 million in budget authority and $83 million of that in user fees because although the fees will continue to be collected, they will remain deposited with the U.S. Treasury. She also provided overviews on the status of implementation of key legislation such as the Family Smoking Prevention and Tobacco Control Act of 2009, the Food Safety Modernization Act and FDASIA as well as discussing aspects of the compounding issue.
Quoted from here
Quoted from here
Senate HELP Committee Seeks Input into Draft Compounding Legislation – In the wake of continuing high profile issues related to compounding, the Senate HELP Committee posted draft legislation this week, seeking input into the draft which is due to the Committee by May 3 at 6 PM (
A link to the draft legislation was posted earlier but is included on Eye on FDA tab that compiles resources related to the developing issues around compounding located on the blog.
Tinton Falls pharmacist in tainted drugs case accused of negligence, misconduct
NEWARK - A Tinton Falls pharmacist could lose his license, and a facility he supervised could lose its permit to operate in New Jersey after shipping mold-contaminated intravenous fluids to a Connecticut hospital.
State Attorney General Jeffrey Chiesa has filed a complaint seeking the revocation of Tinton Falls compounding pharmacy Med Prep Consulting and the revocation of the license of pharmacist-in-charge Stephen Kalinoski over allegations of gross negligence and professional misconduct.
"Our investigation uncovered a disturbing pattern of alleged failures and violations with potentially grave ramifications for public health and safety,” Attorney General Chiesa said. “The State entrusts pharmacies and pharmacists with the ability to safely dispense medications that can be very harmful if contaminated or prepared incorrectly. Pharmacies and pharmacists who have demonstrably failed to live up to that trust, in violation of our laws and statutes, must be held accountable.”
Med Prep Consulting Inc. halted operation in mid-March after recalling its entire line of drugs when contaminated bags of magnesium sulfate it had compounded and dispensed to Yale-New Haven Hospital were found.
No injuries were reported but state and federal regulators, and the company, launched an investigation.
The State Division of Consumer Affairs found a number of violations committed under Kalinoski's supervision, including:
- Incorrectly labeled, packaged and compounded products, with "significant discrepancies" between product and labels in some cases.
- Products inadequately tested for sterility, which "allegedly created the risk that patients would receive non-sterile injectable drugs and be exposed to an unacceptable risk of infection."
- Alleged failure to require the sterilization of equipment and disinfecting of employees.
- Improper use and extension of 'use-by' dates, in some cases, allegedly printing dates more than two weeks later than permitted by state regulation.
- Allegedly failing to properly document its practices and procedures.
- Allegedly falsely representing its practices and and personnel to customers and investigators.
A compounding pharmacy prepares fluids and medications in bulk for hospitals in advance of their use on patients. The 20-year-old company compounds and dispenses more than 80 drugs in infusion bags, plastic syringes and glass vials. The supply is sent to hospital pharmacies throughout New Jersey, Pennsylvania, Connecticut and Delaware.
After giving Med Prep the opportunity to submit an answer to the Attorney General’s Complaint, the Board of Pharmacy will determine whether it will hold a hearing, or refer the State’s Complaint to the Office of Administrative Law for a hearing.
Source found here
Copy of Draft Federal Legislation of FDA Authority Over Compounding
Draft Proposal on Pharmaceutical Compounding
Friday, April 26, 2013
This discussion draft reflects bipartisan efforts to develop consensus policy proposals regarding appropriate regulation of pharmaceutical compounding. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. The discussion draft is available below. Please submit your written comments to compounding@help.senate.gov by 6 PM on May 3, 2013.
Please click here to see the discussion draft.
Please click here to see the section by section.
Please click here to see the one-pager.
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