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Tuesday, July 31, 2012


Marketed Unapproved Drugs and False Claims Act Activities


Information is found at FDA website located  here.

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval Unapproved Drugs Initiative

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval Unapproved Drugs Initiative

Consumer Updates Use Caution with Over-the-Counter Creams, Ointments

Consumer Updates Use Caution with Over-the-Counter Creams, Ointments

Stop online sales of counterfeit drugs, say industry big boys

Stop online sales of counterfeit drugs, say industry big boys

Eu's Newly-Changed Rules On Cgmp Certificate For Bulk Drug Exports



Date :31-Jul-2012
Subject :EU's newly-changed rules on cGMP certificate for bulk drug exports
With the European Union (EU) changing the rules for importing active substances into EU for medicinal products for human use, India may convey the apprehensions of the Indian active pharmaceutical ingredients (API) exporters about the rising cost of transaction costs and seek exemption.

The Commerce Ministry is learnt to have taken note of the changed rules by the EU to be made effective from January 2013 on making mandatory the current good manufacturing practices (cGMP) certificate from the local regulatory authority for all bulk drug exports.

The industry had also apprised the Drug Controller General of India (DCGI) about the hardships including the increase in transaction costs due to the amended laws. Industry leaders, terming the new laws as another non-tariff trade barrier, had urged the Commerce Ministry and the DCGI to take up the matter with the European Union.

Sources said India may convey these apprehensions to the EU in a formal way and seek exemption as sought by some countries like Israel and Switzerland. “The matter is under consideration of the authorities,”a senior official from the Commerce Department said.

To read the remainder of the article click here.

USA: Prescription drug case; ex-Cabell County doctor enters guilty plea

USA: Prescription drug case; ex-Cabell County doctor enters guilty plea

Gustavo Buenrostro in Scandal Involving Prescription Medication Services Company


An indictment returned charges Gustavo Buenrostro, 49, of Arlington Heights with conspiracy to commit bribery in a scandal involving a prescription medication services company. To read entire article, click here.

High Drug Prices Fuel Medicaid Fraud and U.S. Drug Safety Problems

High Drug Prices Fuel Medicaid Fraud and U.S. Drug Safety Problems

Additional Briefs That Have Been Filed in U.S. v. Gary D. Osborn and Apothecure

To view Gary D. Osborn's Brief Relating to Apprendi/Fine argument click here.
To view Government's Response Brief to Osborn's Apprendi/Fine argument click here.
To view Government's Reply Brief click here.

APhA Publishes Fourth Edition of The Art, Science and Technology of Pharmaceutical Compounding


July 25, 2012
WASHINGTON, DC – The American Pharmacists Association (APhA) recently published the fourth edition of the leading textbook on pharmaceutical compounding, The Art, Science and Technology of Pharmaceutical Compounding.
The book is geared to both student pharmacists taking laboratory classes and practicing pharmacists. In a logical and progressive format, it presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding.
For practitioners who already compound prescription medications, the hardbound book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered.
The book is authored by Loyd V. Allen Jr., PhD, Editor in Chief of the International Journal of Pharmaceutical Compounding, Edmond, OK, and Professor Emeritus at the College of Pharmacy, University of Oklahoma, Oklahoma City. Allen has written more than 200 refereed publications and abstracts in the scientific and professional literature. He is a principal author of Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems and he has written a monthly compounding column since 1988 for the trade journal U.S. Pharmacist.
To read remainder of news article and for information on ordering click here.

Monday, July 30, 2012

Oregon Board of Pharmacy to Discuss Registration for Compounding Outlets

The Oregon  Board of Pharmacy has announced its agenda for their meeting scheduled on August 7-8, 2012.  One of the topics on the agenda is the "Appropriate Registration for Compounding Outlets – Schnabel (15 min) #M."  The entire agenda can be found here.

Alabama Rules Regarding Medicaid Reimbursement

Alabama Rules Regarding Medicaid Reimbursement provide:


Compound Drugs for Non-Pharmacy Providers
The compound drug must not be commercially available, and the active
ingredient of the compound drug must follow coverage policy of drugs
(FDA approved, non-DESI, not obsolete, etc).
When a provider administers a drug that must be purchased from a
compounding pharmacy because it is no longer commercially available
(e.g. due to the manufacturer no longer marketing the product), the
applicable claim form may be submitted for consideration of payment.  The
billed amount should represent the lesser of the actual acquisition cost for
the drug or Medicaid rate on file (ASP CMS pricing) at the time of service.
When billing the HCPCS code for a purchased compounded drug, only
one NDC can be used per procedure code.  Providers must use the
HCPCS procedure code, billing units and corresponding covered NDC
number on the claim form; for example, J1094 Injection, dexamethasone
acetate, 1 mg.  The NDC billed should be the one that represents the drug
as described in the HCPCS code definition, in this case dexamethasone
acetate.  See the section entitled “Calculation of Billing Units and
Wastage” for information on calculating billing units.
The Agency does not reimburse non-pharmacy providers for prescription
compounding time or non-covered ingredients used in the compounding
process.  The Alabama Medicaid Agency only reimburses for the
compounding time by the billing of NDC numbers through the Pharmacy
Program.
This guideance can be found here.
.

Recent Docket Entries in US v. Gary Osborn and Apothecure


07/06/2012 32 REPLY filed by USA as to Gary D Osborn, Apothecure Inc re: 28 MOTION Preclude Raising the Fine Ceiling Based on Judge-Found Facts (Claud, John) (Entered: 07/06/2012)
07/09/2012 33 MOTION for Leave to File Reply Brief filed by Gary D Osborn, Apothecure Inc (Attachments: # 1 Exhibit A) (Shields, Robert) (Entered: 07/09/2012)
07/09/2012 34 NOTICE of Intent to Travel Internationally as to Gary D Osborn. (Shields, Robert) Modified filers on 7/10/2012 (axm). (Entered: 07/09/2012)
07/10/2012 35 RESPONSE by USA as to Gary D Osborn, Apothecure Inc re: 33 MOTION for Leave to File Reply Brief (Claud, John) (Entered: 07/10/2012)
07/12/2012 36 ORDER granting 33 Motion for Leave to File Reply Brief as to Gary D Osborn (1), Apothecure Inc (2). Replies due by 7/20/2012. (Ordered by Judge Barbara M.G. Lynn on 7/12/2012) (cea) (Entered: 07/12/2012)
07/13/2012 37 REPLY filed by Gary D Osborn, Apothecure Inc re: 28 Motion to Preclude Raising the Fine Ceiling Based on Judge-Found Facts (Man, Christopher) Modified doc. linkage on 7/16/2012 (ctf). (Entered: 07/13/2012)
07/17/2012 38 NOTICE OF ATTORNEY APPEARANCE by Abbe D Lowell appearing for Gary D Osborn, Apothecure Inc. (ctf) (Entered: 07/17/2012)

New Rules Adopted in Alabama

The Alabama State Board of Pharmacy has amended Title 34 PRACTICE OF PHARMACY
 ACT 205
 as was discussed during the July 18-19th meeting (see here).   Previous post addressed the incident in Alabama where 9 people died and the need for reform.  (see here).   The amendments are effective July 20, 2012, and can be found here.



Sunday, July 29, 2012

Compounding to Be Discussed at Utah State Board of Pharmacy Meeting on July 31, 2012


The Utah State Board of Pharmacy will be meeting on July 31, 2012 at 8:30 am at the Heber M. Wells Building, 160 E. 300 S., Room 474-4th Floor, Salt Lake City, Utah.  The second published agenda provides notice that there will be a discussion regarding the definition of "extensive" compounding and adopting compound rules consistent with CFR.  The notice of agenda can be found here

Preventing Compounding Errors in Wyoming


This article appeared in the December 2011 Wyoming State Board of Pharmacy Newsletter:

Preventing Compounding Errors
By Amy Puckett, PharmD Candidate
There are an estimated 30 to 40 million prescriptions compounded
nationally each year. A small portion of those are for Wyoming
residents and the compounding pharmacy must follow Wyoming
Pharmacy Act Rules and Regulations. Being familiar with the
Wyoming Pharmacy Act Rules and Regulations can help reduce
compounding errors. Rules are designed to help protect both the
pharmacist and the public. A compounded product can be prepared
for three reasons: as the result of a practitioner’s order; for research,
teaching, or chemical analysis; or in anticipation of orders if the drug
product is regularly prescribed. It is not considered compounding
when mixing or reconstituting as a result of following the manufacturer’s
directions on the labeling. Pharmacies cannot compound
medications or dosage forms that are commercially available and
they cannot sell compounded products to other pharmacies for
resale. A pharmacy may, however, sell a compounded product to a
practitioner or an institutional pharmacy if it is to be administered
to patients in the practitioner’s office or institution. The provision to
this is that neither the transfer pharmacy nor the transferee pharmacy
can exceed 5% of their total prescription drug sales revenue when
selling the compounded products.

To continue reading this article, click here.

Managing Drug Recalls in the Compounding Environment : July 2012 : Drug Distribution - Pharmacy Purchasing & Products Magazine

Managing Drug Recalls in the Compounding Environment : July 2012 : Drug Distribution - Pharmacy Purchasing & Products Magazine

Saturday, July 28, 2012

IND for Estriol in hormone therapy

From FDA website Obtaining an IND for Estriol Some menopausal hormone therapy drugs compounded by pharmacies contain the ingredient estriol. Estriol is not a component of any FDA approved drug and it has not been shown to be safe and effective for the uses for which it is being prescribed. Under a well-established policy, pursuant to an Investigational New Drug Application (IND), FDA permits drug compounding with active ingredients that - like estriol - are not components of FDA-approved drugs. The Agency's position has been improperly cast as a ban on estriol. But FDA has repeatedly stated that it respects a healthcare provider's decision that his or her patient should receive estriol. At the same time, FDA must assure that patients receive accurate information about the risks and benefits of unapproved drug therapies so that they can make informed decisions about those therapies. The requirement for patients to give informed consent when receiving a product under an IND ensures that patients receive important safety information. Another advantage of INDs is their requirement that practitioners collect and report adverse event information to FDA. There are some misconceptions that obtaining an IND is a costly, cumbersome, and time consuming process. To the contrary, INDs are well known, well understood, and widely used in the healthcare community. Thousands of physicians use INDs every day to treat patients with drugs that have not been approved by FDA. FDA does not charge a fee to file an IND, although review fees may be charged by private Institutional Review Boards. In addition, FDA has streamlined the IND process for estriol to make it as efficient and convenient as possible for practitioners, while still maintaining patient safety. Under this streamlined process, FDA is willing to accept INDs covering multiple patients, on behalf of multiple health care providers, and for a range of doses. The general requirements for practitioners filing an IND application for estriol are: Completed FDA Form 1571 Drug formulation and chemistry information including: Names and addresses of the pharmacies making the drugs Attestation from the pharmacies that they will use only USP/NF grade ingredients and adhere to USP processes and procedures when preparing the compounded products Detailed description of the drug formulation that will be used (ingredients, quantities, and production processes) Clinical information including: Number of patients Types of symptoms that will be treated by the drugs Dose ranges for each formulation Monitoring procedures, including safety monitoring Copy of current medical license of the practitioner For more information regarding IND or new drug application submissions for drugs containing estriol, please contact Margaret Kober in the Division of Reproductive and Urologic Products at 301-796-0934. Please submit all completed IND applications for estriol to the following address: Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville, MD 20705 Attn: Margaret Kober -

"Office Use" in Tennessee: Does this Apply to Compounded Drugs?


This article appeared in the Tennessee Board of Pharmacy January 2012 newsletter, which is found here:

Understanding the Correct Transfer for ‘Office Use’
Pharmacists have often asked how to follow the proper procedures
when transferring a medication to another pharmacy
or prescribing practitioner. Please note that the only place in
the Tennessee Board of Pharmacy rules that mentions “office
use” is in Rule 1140-06-.02 (5), which states “ . . . A nuclear
pharmacy practice site may also furnish radiopharmaceuticals
for office use to authorized practitioners for individual patient
use . . . ”
Therefore, what is allowed? Refer to Tennessee Board of
Pharmacy Rule 1140-09-.01, which states:
“ . . . (3) The requirement of a license [referring to a
Manufacturer/Wholesaler license] shall not apply to
the following types of distributions . . . [*](i) The sale,
purchase or trade of a prescription drug, or an offer
to sell, purchase or trade of a prescription drug by a
pharmacy practice site to another pharmacy practice
site or to authorized prescribing practitioners, except
that the total gross dollar volume of such transfers
shall not exceed five percent (5%) of the total medical and
prescription orders sales revenue of either the
transferor or transferee pharmacy during any twelve
(12) consecutive month period . . . ”
Therefore, instead of transferring pursuant to a prescription
for “office use only,” pharmacists are advised to invoice
the medication or medical device while complying with section (i),
and hold this readily retrievable record for two years.
In this manner, the medication can then be delivered to the
prescribing practitioner’s office or pharmacy.
Furthermore, the rules change/add when dealing with a
controlled substance. For a Schedule II medication, Drug
Enforcement Administration (DEA) Form 222 must be
completed between the seller and buyer, while one copy is
kept in the pharmacy for two years per Title 21, Code of
Federal Regulations (CFR) 1307.11, which may be found at
the following Web link: www.deadiversion.usdoj.gov/21cfr/
cfr/1307/1307_11.htm. An invoice with the following information
must also be kept for Scheduled III through V medication
including the name, address, and DEA registration number of
both parties, the name, strength, quantity, and dosage form of
the drugs, and the date of the transaction, pursuant to CFR
1304.22. CFR 1304.22 may be found at the following Web
link: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.
htm. It is advised to obtain a signature of each registrant
on the invoice. This record must be kept for two years per
DEA CFR 1304.04., found at the following Web link: www
.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm.
According to CFR 1307.11, the pharmacy must make certain
that the distribution “. . . does not exceed 5% of total dosage
units of controlled drugs dispensed and distributed during the
same calendar year unless licensed as a distributor by DEA .
. . ” This regulation is in addition to the Tennessee Board of
Pharmacy rule stated previously, which refers to 5% of total
order sales revenue. (See asterisked section of Rule 1140-
09-.01 referenced at the beginning of this article.)

Bienick v. Franck's Lab: Extension of Time Granted

In Bienick v. Franck's Lab, Inc., the court has granted Franck's an extension of time to file a response to the complaint.  Franck's response is now due on August 14, 2012.  See docket entry below.


7/24/2012 11   ORDER GRANTING 10 Motion for Extension of Time to File Response to Complaint to/including 8/14/12. Signed by Magistrate Judge Roger B Cosbey on 7/24/12. (jcp) (Entered: 07/24/2012)

Friday, July 27, 2012

Drug Shortage Articles


The following resources regarding drug shortages can be found here:

Prednisone shortage worries medical professionals

“Drug shortages are a national healthcare crisis because what we’re seeing is that because of unavailability of certain medications, healthcare providers are having to rely on second or third line medications, which they may not be as familiar with,” said Melinda Burnworth, a pharmacist and professor at Midwestern University.
She also said several factors can contribute to drug shortages, including large companies consolidating, drug contamination and discontinuation of medical products. She said if you are affected by this or think you might be, have a conversation with your doctor.
You can also visit these sites for more information:
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

...Read more from CBS5 KPHO News:

http://www.kpho.com/story/19126517/prednisone-shortage-worries-medical-professionals

...Related News Articles:

  1. Paramedics turn to expired drugs due to shortages SALEM, OR (AP) - Emergency responders in various jurisdictions, including Arizona, have reported struggling to deal with a shortage of drug supplies created by manufacturing delays and industry changes. Some paramedics are injecting expired medications, despite a risk they won’t work as intended. Others are...
  2. FOX 10 News – Phoenix, AZ | KSAZ-TVOkla. inmate: Drug shortage should halt … By SEAN MURPHYAssociated Press OKLAHOMA CITY (AP) – A death row inmate has asked a federal court to halt his execution next month because Oklahoma has only one dose left of a lethal injection drug, and it might not work. Pentobarbital has become hard to...
  3. Valley hospitals face drug shortage, forced to use smaller doses – ABC15.com (KNXV PHOENIX – Hospitals around the country, including ones here in the Valley, are having a tough time getting drugs they use everyday. According to the AZ Board of Pharmacy, at least 200 drugs are in short supply, including painkillers and anesthetics. A drug shortage has...
  4. FDA thinks shortage of cancer drug for kids can be averted By Steven ReinbergHealthDay Reporter TUESDAY, Feb. 14 (HealthDay News) — The U.S. Food and Drug Administration said Tuesday that it was cautiously optimistic that a feared shortage of a life-saving drug used to treat a form of childhood leukemia will be averted. The drug, methotrexate,...
  5. ADHD drug shortage pushes parents to seek substitutes By Serena GordonHealthDay Reporter FRIDAY, Jan. 6 (HealthDay News) — If the current shortage of some drugs used to treat attention-deficit/hyperactivity disorder (ADHD) has left you searching for something else for your child to take, experts suggest you choose a substitute carefully because the effects...

Tramadol-Containing Products Will Be Classified as Schedule IV Drugs in Oklahoma Effective July 12, 2012


This notice appears on the Oklahoma State Board of Pharmacy website located here:

July 12, 2012
Effective November 1, 2012, tramadol and all tramadol-containing products will be classified as Schedule IV in the State of Oklahoma. Pharmacies are required to take an inventory of their tramadol products on November 1st and keep it with their annual CDS inventory. Make sure that you start submitting all tramadol prescription information to the prescription monitoring program as required per OBNDD rules beginning November 1st as well.
Beginning November 1st:
  • All tramadol-containing prescriptions older than six (6) months will be expired.
  • All tramadol-containing prescriptions less than six (6) months old but with more than 5 refills already dispensed will be expired.
  • All tramadol-containing prescriptions less than six (6) months old but with up to 5 refills remaining should be valid for the remainder of the six (6) months period and up to the remaining but not to exceed the 5 refills on a controlled prescription.
The pharmacist may have to rewrite the prescriptions for filing purposes. They need to be sure to reference them back properly to the original prescription number.

CDC and ASCA meet to discuss Injectable Drugs in Single-Dose and Multi-Dose Vials and Whether A Compounding Pharmacy Can Divide Vials via 797

ASCA representatives met with Centers for Disease Control and Prevention (CDC) staff this past week to discuss issues affecting the ASC industry, particularly those related to injectable drugs packaged in single-dose and multi-dose vials. Attending the meeting were ASCA CEO Bill Prentice, ASCA Director of Education and Clinical Affairs Gina Throneberry, MBA RN CNOR ONC CASC, ASCA Board Member David Shapiro, MD, and ASCA consultant Marian Lowe.
The CDC gave ASCA an overview of the process behind their various recommendations, including their position on single-dose/single-use vials. An outline of past and recent outbreaks of infectious diseases associated with unsafe injection practices was also discussed by the CDC.
The ASCA representatives voiced concerns received from members with regard to the lack of science behind these recommendations, and asked for clarity from the agency as to why a more nuanced process pertaining to single-use vials could not be developed that would protect patients while eliminating the drug waste that currently occurs. They also briefed the agency on the different injectable drugs that ASCA members were either in having difficulty obtaining or are hard to find in appropriate doses. Finally, they rebutted the CDC’s notion that ASCs could use a compounding pharmacy to divide single-use vials via the US Pharmacopoeia (USP) 797.
The CDC staff stated that they would work to develop a clearer explanation for their position on single-use vials and pledged to work with us and other federal agencies to address both the drug shortage and drug packaging issues that are impacting patient care in ASCs. We agreed to continue our discussions after ASCA meets with the US Food and Drug Administration (FDA) on these topics next month.I
For more information, contact Gina Throneberry at gthroneberry@ascassociation.org
This article is found here

August Meeting Agenda of Texas Board of Pharmacy Includes Recall Procedure Amendments Again


To view the August 2012 agenda for the Texas Board of Pharmacy meeting, click here.  On the agenda again in August for discussion are the amendments relating to the recall of compounded preparations

RULE ANALYSIS
Introduction: THESE AMENDMENTS ARE SUBMITTED TO THE BOARD FOR CONSIDERATION AS ADOPTED RULES
Short Title: Recall Procedures
Rule Numbers: §§291.131, 291.133
Statutory Authority: Texas Pharmacy Act, Chapter 551-566 and 568-569, Occupations Code:
(1) Section 551.002 specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; and
(2) Section 554.051 gives the Board the authority to adopt rules for the proper administration and enforcement of the Act.
Purpose: The amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Background: Board staff presents these recommendations to clarify the recall procedures for pharmacies compounding sterile and non-sterile preparations.
The Board reviewed and voted to propose the amendments during the May 8, 2012, meeting. The proposed amendments were published in the June 22, 2012, issue of the Texas Register at 37 TexReg 4523.

Texas Pharmacy Laws

For a list of pharmacy laws and regulations in the state of Texas, click here.

New Senate Report IDs Gray Market Players, Including Some Surprising Names

New Senate Report IDs Gray Market Players, Including Some Surprising Names

Courthouse News Service

Courthouse News Service

K-V v. FDA: K-V's Response to Amici Request to File Brief

To view K-V's Response to Amici Curiae Alere Women's and Children's Health LLC and Interested Physicians Request to file Brief click here.

Recent Docket Entries for K-V v. FDA


07/24/2012 9   MOTION for Leave to File a Brief Amici Curiae in support of Defendants by ALERE WOMEN'S AND CHILDREN'S HEALTH, LLC, JOHN P. ELLIOTT, MICHAEL GORDON, JACK GRAHAM, KENNETH HIGBY, STEPHEN JONES, CHRISTOPHER LANG, MICHAEL MORETTI, SUE PALMER, MICHAEL RUMA, PETER S. SANFILIPPO, PHILLIP SHUBERT (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Appendix 1, # 4 Appendix 2, # 5 Appendix 3)(rdj) (Entered: 07/25/2012)
07/25/2012 10   RESPONSE re 9 MOTION for Leave to File Amicus Brief filed by K-V PHARMACEUTICAL COMPANY. (Pinkel, Michael) (Entered: 07/25/2012)
07/26/2012    MINUTE ORDER granting 9 Motion for Leave to File. It is ORDERED that the motion by Alere Women's and Children's Health, LLC, and interested physicians for leave to file an amicus brief is GRANTED. No response by plaintiffs is required. If plaintiffs choose to respond, they may file an additional pleading, not to exceed ten pages, addressing only any arguments raised by the amici that were not raised by the FDA, and not repeating any arguments already advanced by plaintiffs, by July 31, 2012. The Clerk is directed to docket Attachments 2, 3, 4, and 5 of 9 (Exhibit B and Appendices 1, 2, and 3). Signed by Judge Amy Berman Jackson on 7/26/12. (lcabj1) (Entered: 07/26/2012)
07/26/2012    Set/Reset Deadlines: If plaintiffs choose to respond to the submission of the Amici, they may file an additional pleading, not to exceed 10 pages, addressing only any arguments raised by the amici that were not raised by the FDA, and not repeating any arguments they have already advanced. Plaintiffs Response (if any) is due by 7/31/2012. (jth) (Entered: 07/26/2012)
07/26/2012 11   AMICUS BRIEF by ALERE WOMEN'S AND CHILDREN'S HEALTH, LLC. (jf, ) (Entered: 07/27/2012)

K-V v. FDA Amici Brief Filed By Alere Women's and Children Health, LLC and Interested Physicians

To view the brief filed by amici curiae Alere Women's and Children Health, LLC and Interested Physicians in K-V vs. FDA, click here.
To view exhibit 1 to brief filed by amici curiae, click here.
To view appendix 1 to brief filed by amici curaie, click here.
To view appendix 2 to brief filed by amici curiae, click here.
To view appendix 3 to brief filed by amici curiae, click here.
To view K-V's response to brief filed by amici curiae, click here.

Motion to Dismiss and Memorandum in Support filed by FDA in case filed by K-V

To view the motion to dismiss, click here.
To view the memorandum in support of the motion to dismiss, click here.
To view exhibit 1 to memorandum in support of the motion to dismiss, click here.
To view exhibit 2 to memorandum in support of the motion to dismiss, click here.
To view exhibit 3 to memorandum in support of the motion to dismiss, click here.
To view exhibit 4 to memorandum in support of the motion to dismiss, click here.
To view exhibit 5 to memorandum in support of the motion to dismiss, click here.
To view the proposed order to the motion to dismiss, click here.

Extension of Time for Franck's to Respond in Bienick case

7/20/201210 MOTION for Extension of Time to File Response/Reply (Unopposed) For Additional Time Within Which to Respond to Complaint by Defendant Franck's Lab Inc. (Peters, Stephen) (Entered: 07/20/2012)

07/24/201211 ORDER GRANTING 10 Motion for Extension of Time to File Response to Complaint to/including 8/14/12. Signed by Magistrate Judge Roger B Cosbey on 7/24/12. (jcp) (Entered: 07/24/2012)
Bienick

Wednesday, July 25, 2012

Clinical Trial Deaths in India

http://www.pharmalot.com/2012/07/clinical-trial-deaths-in-india-dropped-but/

FDA Continues To Take Strong Action During Inspections

http://www.pharmalot.com/2012/07/fda-to-meet-sanofi-execs-over-vaccine-plants/

K-V Announces Additional Notification From NYSE Regarding Listing Criteria

http://www.biospace.com/company_profile.aspx?CompanyId=2299

Warning Letter Issued to Brunner Farms

Department of Health and Human Services Public Health Service Food and Drug Administration   Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7133 FAX: (612) 334-4142   July 12, 2012     WARNING LETTER     CERTIFIED MAIL RETURN RECEIPT REQUESTED                           Refer to MIN 12 - 38     Clyde J. Brunner Owner Brunner Farm 4757 Algoma Road New Franken, Wisconsin 54229   Dear Mr. Brunner:   On April 3 and 10, 2012, the Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at 4757 Algoma Road, New Franken, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.    Our investigation documented that you sold prescription veterinary drugs, such as dinoprost tromethamine, dexamethasone, ceftiofur hydrochloride, and flunixin meglumine, without a written prescription or oral order from a licensed veterinarian. Under section 503(f)(1)(C) of the FD&C Act, the dispensing of a prescription drug other than by or upon the lawful written or oral order of a licensed veterinarian results in the drug being misbranded.   In addition, the prescription drugs that you sold/dispensed are misbranded within the meaning of section 502(f)(1) of the FD&C Act because they lack adequate directions for use. Pursuant to Title 21, Code of Federal Regulations, section 201.5, “adequate directions for use” means adequate directions under which the layman can use a drug safely and for the purposes for which it was intended. Such adequate directions for use by laypersons cannot be written for prescription drugs because the drugs can only be used safely at the direction of, and under the supervision of, a licensed veterinarian.   You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.    Our investigation also revealed that you are not keeping complete drug treatment records and that you lack an adequate drug inventory system. Our investigator provided examples of drug treatment and inventory forms to you. In your affidavit dated April 10, 2012, you stated that you would review the forms and try to implement them.   You should notify this office in writing of the steps you have taken to bring your operation into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.   Your written response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.   Sincerely, /S/  Michael Dutcher, D.V.M. Director Minneapolis District     xc:   (b)(4)   Robert Ehlenfeldt, D.V.M. State Veterinarian Wisconsin Department of Agriculture Division of Animal Health P.O. Box 8911 Madison, Wisconsin 53708-8911 - - Page Last Updated: July 25, 2012 Letter is found at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312617.htm

Many Drugs Remain Legal After "Bath Salts" Ban by THE ASSOCIATED PRESS

http://www.npr.org/templates/story/story.php?storyId=157345017

Thursday, July 19, 2012

Update on Changes to Regulations in California Relating to Compounding

The 15-day comment period for the proposed changes to compounding regulations in California expires July 30, 2012.  The notice of proposed action can be found here.  The proposed Compounding Self-Assessment Form can be find here.  The Initial Statement of Reasons for the Changes can be found here.  The notice of modified text can be found here.  The modified proposed language can be found here.

Prior post on changes to California regulations relating to compounding can be viewed here.

Mississippi State Board of Pharmacy In Process of Revising Regulations

The Mississippi State Board of Pharmacy website indicates that the board is in the process of updating its current regulations.  This appears to include the regulations relating to compounding in Mississippi.  Notice of future changes can be viewed here.  Check back to this blog for future changes in Mississippi Pharmacy Law.


Also note that changes in the Pharmacy Practice Act and Regulations (effective January 1, 2012) require the pharmacist-in-charge of all non-resident pharmacies be licensed as a pharmacist in the State of Mississippi. In addition, all non-resident pharmacies and wholesalers are required to obtain a Mississippi Controlled Substance Registration issued by the Board.  See MS Senate Bill 2455 .


Instruction and Form for Filing for Application for Sterile Compounding Pharmacy Licence in Califorinia

The form for filing for application to compound injectable sterile drug in California is found here.  The form details who may compound injectable sterile drug products in California:
A pharmacy that is specially licensed with the board as a sterile compounding pharmacy, or a pharmacy that is operated by an entity that is licensed by the board or the State Department of Health Services and has a current accreditation from the Joint Commission on Accreditation of Healthcare Organizations or another accreditation agency approved by the board. The following private accreditation agencies have been approved by the board:

Accreditation Commission for Health Care, Inc. (ACHC) through February 2014,
Community Health Accreditation Program (CHAP) through February 2014,
Det Norske Veritas (DNV) through July 2013,
Pharmacy Compounding Accreditation Board (PCAB) through February 2014, or
American Osteopathic Association Healthcare Facilities Accreditation Program
(HFAP) through February 2014.
The form explains that "[a} license to compound injectable sterile drug products may not be issued until the location is inspected by the board and found to be in compliance with Article 7.5 of
Chapter 9, of Division 2 of the Business and Professions Code and regulations adopted
by the board."  The form also contains the following warning:  "All pharmacies that compound injectable sterile drug products must follow board regulations for sterile compounding. These regulations are found in Title 16 of the California Code of Regulations as Article 8, beginning with section 1751."  A $600 fee is required with the application.  Both a state and federal background check are required.  




Indian API production takes hit as APPCB shuts 12 plants

Indian API production takes hit as APPCB shuts 12 plants

Wednesday, July 18, 2012

Upcoming Veterinary Meetings

Aug. 2-4
Kansas City, Mo.
Academy of Veterinary Consultants Summer Meeting
            913-766-4373      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.avc-beef.org/meetings/future.asp
Aug. 4-7
San Diego, Calif.
American Veterinary Medical Association Annual Convention 
            800-248-2862      , ext. 6621, AVMAconvention.org
Aug. 11-15
Louisville, Ky.
Association of Avian Veterinarians 33rd Annual Conference and Expo — Avian and Exotic Medicine
            303-756-8380      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.conferenceoffice.com/aav
Aug. 16-17
Toronto, Ontario, Canada
2nd Annual CanCog Conference
on Behavior, Cognition and Aging in Companion Animals

Offered by International Veterinary Senior Care Society
http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.canineconference.com
Aug. 22-28
Kansas City, Mo.
CVC Kansas City
            800-255-6864      , ext. 6, TheCVC.com
Sept. 8-11
Birmingham, Ala.
American Holistic Veterinary Medical Association 30th Annual Conference
http://www.veterinarypracticenews.com/redirect.aspx?location=mailto:office@ahvma.org, meetings.ahvma.org
Sept. 15-18
St. Paul, Minn.
Allen D. Leman Swine Conference
Offered by University of Minnesota
            800-380-8636      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.cvm.umn.edu/vetmedce/events/adl
Sept. 18-21
West Lafayette, Ind.
Purdue Veterinary Medicine 2012 Fall Conference
Offered by Purdue University College of Veterinary Medicine
            765-494-0611      , /redirect.aspx?location=www.vet.purdue.edu/2012fallconference
Sept. 20-22 
Montreal, Quebec 
American Assn. of Bovine Practitioners 45th Annual Conference 
            334-821-0442      , AABP.org
Sept. 20-23
Dallas, Texas
Southwest Veterinary Symposium
http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.swvs.org
Sept. 27-30
Ithaca, N.Y.
New York State Veterinary Conference
Offered by New York State Veterinary Medical Society
and Cornell University College of Veterinary Medicine
            607-253-3200      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.vet.cornell.edu/education/Conferences/NYSVetConf
Oct. 10-13
Reno, Nev.
Wild West Veterinary Conference
            800-775-7062      , WildWestVC.com
Oct. 18-21
Las Vegas, Nev.
Veterinary Cancer Society Annual Meeting
Offered by Veterinary Cancer Society
            573-823-8497      , VetCancerSociety.org
Oct. 19-21
Vancouver, British Columbia, Canada
Veterinary Hospital Managers Association Annual Conference
            877-599-2707      , m360.vhma.org
Nov. 1-3
Washington, D.C.
American College of Veterinary Surgeons Symposium 
            301-916-0200      , ACVS.org
Nov. 8-11
Seattle, Wash.
26th Annual Veterinary Dental Forum
            931-438-0238      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.veterinarydentalforum.com
Nov. 13-15
Columbus, Ohio
2nd National Symposium on Antibiotic Use in Food Animals
Offered by National Institute for Animal Agriculture
            719-538-8843      , http://www.veterinarypracticenews.com/redirect.aspx?location=http://www.animalagriculture.org
Dec. 1-5
Anaheim, Calif.
American Association of Equine Practitioners 58th Annual Convention
            859-233-0147      , http://www.veterinarypracticenews.com/redirect.aspx?location=mailto:aaepoffice@aaep.org, AAEP.org
Dec. 5-9
San Diego, Calif.
CVC San Diego
            800-255-6864      , ext. 6, TheCVC.com

Source found here.