Pharmacy Organization's Statement on HELP Committee Proposed Pharmaceutical Compounding Bill

Pharmacy Organization's Statement on HELP Committee Proposed Pharmaceutical Compounding Bill

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

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

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