Duane Morris Summary of New Federal Draft Legislation

ALERTS AND UPDATES

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between "Traditional Compounders" and "Compounding Manufacturers"

April 29, 2013

While the Proposal's creation of two new regulatory categories for traditional compounders and compounding manufacturers represents a significant change, the most sweeping change under the Proposal is the inclusion of compounded drugs as a "new drug" under the Federal Food, Drug, and Cosmetic Act.

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on Health, Education, Labor & Pensions ("HELP") releasedproposed legislation ("Proposal") aimed at regulating compounding pharmacies. The Proposal makes compounds "new drugs" under the Federal Food, Drug, and Cosmetic Act ("FFDCA"), subjecting all compounds to federal regulation. The Proposal also draws a bright line, defining some compounders as "traditional compounders," and creates a new category called "compounding manufacturers." While the legislation has a long road until it becomes law, compounding pharmacies should consider closely analyzing the provisions now, as the Proposal fundamentally changes the regulation of compounding pharmacies.

What Is a "Compounding Manufacturer" Under the Proposal?

Compounding pharmacies are presently licensed under state pharmacy laws. The Proposal, however, divides compounding pharmacies into two categories for purposes of federal regulation: (1) traditional compounders and (2) compounding manufacturers.

Under the Proposal, a traditional compounder would be limited to entities where a drug is compounded by a licensed pharmacist, physician or veterinarian that compounds the drug either (1) upon receipt of a prescription order for an identified individual patient or (2) in limited quantities before receipt of a prescription order for an identified individual patient in certain limited circumstances.¹ Although a traditional compounder would continue to be state licensed pharmacies, under the Proposal, it would be subject to additional federal requirements.

However, a compounding manufacturer would be defined as an entity that compounds a sterile drug prior to receiving a prescription and introduces the drug into interstate commerce.² The new definition of compounding manufacturer also includes entities that pool sterile products or that repackage sterile, single-use, preservative-free vials. Under the Proposal, compounding manufacturers cannot be licensed as pharmacies under state laws.

What Are the New Requirements Under the Proposal?

While the Proposal's creation of two new regulatory categories for traditional compounders and compounding manufacturers represents a significant change, the most sweeping change under the Proposal is the inclusion of compounded drugs as a "new drug" under the FFDCA. This creates a presumption that compounded drugs are subject to the FFDCA's registration, new drug, manufacturing practices and other requirements, unless an exemption applies.

If any entity meets the new definition of a traditional compounder, it would be exempt from the FFDCA requirements for Current Good Manufacturing Practices ("CGMPs"), adequate directions for use regulations and the new drug provisions.

If an entity meets the definition of a compounding manufacturer, it would be exempt from the new drug and adequate directions for use regulations. Significantly, however, compounding manufacturers would be required to comply with the CGMPs and would not be exempt from the FFDCA's registration and inspection exemptions.

The Proposal would also require compounding manufacturers to:

• Compound products under the direct oversight of a pharmacist licensed in the state in which the compounder is located.
• Make biannual reports of drugs sold.
• Report serious adverse events within 15 days; investigate, follow up and report adverse event experiences; and maintain records of adverse events for 10 years.
• Develop enhanced labeling that includes a statement identifying the drug as a compounded drug. Compounded drugs without these labels will be deemed misbranded.
• Pay a $15,000 annual fee designed to defray the costs for inspection and regulation.³

Finally, the Proposal identifies three categories of drugs that may not be compounded: (1) complex dosage forms and biologics, (2) marketed drugs or "copies" and (3) drugs removed from the market based on safety and efficacy concerns.

Limitations on the Sale of Compounded Drugs

The Proposal also imposes certain limitations on the sale of compounded drugs. Compounded drugs, whether from a traditional compounder or compounding manufacturer, may not be sold by an entity other than the compounding manufacturer or traditional compounder that compounded the drug. Similarly, the compounded drug may not be sold to an entity other than a healthcare entity that provides medical services through licensed prescribers directly to patients, except in cases where a traditional compounder dispenses the drug directly to an individual or in inter-corporate transfers to a licensed pharmacy for the sole purpose of dispensing compounded drugs to the end user for self-administration. Drugs sold to healthcare entities must also be marked "not for resale."

Criminal Penalties

It is important to note that the Proposal makes it unlawful to resell a compounded drug that is labeled "not for resale." These sales are not prohibited under the FFDCA and carry penalties of up to one year in prison and/or up to a $1,000 fine. Additional penalties may be imposed if the resale is committed with the intent to defraud or mislead; such sales are punished by up to three years in prison and/or up to a $10,000 fine.

Continue reading here

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

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  

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.

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.

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.

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 

Texas State Board of Pharmacy Meeting Scheduled for May 7, 2013; Task Force on Compounding of Sterile Preparations Is In Agenda

To view complete agenda click here

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 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 

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.

We're dedicated to patients' health: Another view by David Miller

David G. Miller6:29 p.m. EDT April 28, 2013

  Source quoted from USAToday

Let state boards enforce national standards

STORY HIGHLIGHTS

• NECC was essentially manufacturing drugs, not compounding.
• We're studying the bill released by several senators Friday.
• We're concerned that some provisions could reduce patient and physician access to customized medications.

When the tragic news of the deaths and sickness associated with products made at the New England Compounding Center came out last fall, the nation's attention appropriately focused on what went terribly wrong — and what steps to take to keep anything like it from ever happening again.

OUR VIEW: Time to fix 'broken' system

Pharmacists were more concerned than anyone because our profession is dedicated to one thing: the health of the patients we serve by compounding drugs upon request from authorized prescribers, such as doctors. NECC was essentially manufacturing drugs, not compounding.

The difficult matter that the public, the industry, policymakers and Congress are wrestling with is what regulations, laws or jurisdictions must be changed to make sure no NECCs happen again.

The International Academy of Compounding Pharmacists, representing 3,000 pharmacists nationwide, is studying the bill released by several senators Friday. We applaud the steps the Senate is taking to ensure that compounded medications are as safe as they can be.

But we believe aspects of the draft will need further discussion and refinement, and we intend to work with the committee on these. We plan to offer suggestions on improving standards to raise the quality of compounded medications.

Our group is also concerned that some provisions could reduce patient and physician access to customized medications, the very essential services that compounding pharmacists provide. We support nationwide standards enforced by each state's board of pharmacy, the entities that have traditionally regulated compounding pharmacies.

We also want to eliminate loopholes and don't believe that any group of pharmacies should be exempted from regulatory change, as this bill would do.

The states are responsible for licensing and oversight of medical providers, including compounding pharmacies, and the FDA is and should be responsible for pharmaceutical manufacturers. The terminology and some definitions in the proposed category of "compounding manufacturers" create confusion and blur authority of regulators. Our group will recommend improvements to make the proposed categories clearer.

Our members look forward to finding the right steps to ensure the safety of patients everywhere — steps that won't prevent compounding pharmacists from continuing to serve the public's vital health needs.

David G. Miller is CEO of the International Academy of Compounding Pharmacists.

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.
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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

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

By Cathy Dombrowski / Email the Author / Apr. 26, 2013 

Word Count: 1080 / Article # 14130426008 / Posted: April 26 2013 6:55 PM

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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.

U.S. Files 2nd Suit Accusing Novartis of Kickbacks to Doctors - Top Headlines on DecaPost.com

U.S. Files 2nd Suit Accusing Novartis of Kickbacks to Doctors - Top Headlines on DecaPost.com

Compounding pharmacies may be source of lethal injection drugs

Compounding pharmacies may be source of lethal injection drugs

PharMEDium Supports Draft Legislation, Efforts to Strengthen Oversight of the Compounding Industry

PharMEDium Supports Draft Legislation, Efforts to Strengthen Oversight of the Compounding Industry

Numerous Free Powerpoint Presentations on Compounding

can be found here

Powerpoint on Inspection of Pharmacy for Compliance to Florida Law done on April 8, 2013

can be viewed here

COMPOUNDING – Are you following the rules? Dr. Lynne White-Shim MS, DVM Assistant Director, Scientific Activities American Veterinary Medical Association Powerpoint

can be viewed here

Compounding Policy Update from AVMA

April 25, 2013 | AVMA@Work Editor |

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

Excellent Powerpoint presentation by Gigi Davidson on Compounding for Lab Animals

can be viewed 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

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]