Friday, June 28, 2013

Job Opening For Veterinary Pharmaceutical Representative

Animal Health Sales - DGW 204

General
Location
San Antonio, Texas
Job code
DGW 204
Function
Sales
Call point
-Other-
Segment
Veterinary
Category
Pharmaceutical
Date Expires
07/20/2013
Compensation
Compensation
$105,000 - $115,000
Comp Type
Salary + Commission + Bonus
Salary
$65,000 - $75,000
Bonus
---
Commission
$20,000 - $50,000
Auto package
Company Car
Travel
20 - 30%

Thursday, June 27, 2013

Senators Join Slaughter In Push For Animal Antibiotic Restrictions Sen. Diane Feinstein (D-CA) Thursday (June 27) introduced legislation similar to a House bill requiring FDA to phase out the non-therapeutic use of antibiotics in animals.

source found here

The Law of Compounding Medications And Drugs: Other Actions for Junk Faxes Filed by Dr. Mark W. ...

The Law of Compounding Medications And Drugs: Other Actions for Junk Faxes Filed by Dr. Mark W. ...: In previous post found here , the case against Lowlite Investments Inc d/b/a Olympia Pharmacy was highlighted.  It appears the other acti...

Update on Status of Dr. Mark W. Sturdy v. Lowlite ...

The Law of Compounding Medications And Drugs: Update on Status of Dr. Mark W. Sturdy v. Lowlite ...: Defendant John Does 1-10 Date Filed # Docket Text 04/30/2013 1   COMPLAINT  against John Does 1-10, Lowlite Investments, Inc., d/b/a...

How an animal health hub is developing on Canada's 'Million-Acre Farm' - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

How an animal health hub is developing on Canada's 'Million-Acre Farm' - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Piedmont secures first US approval for soft chew analgesic - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Piedmont secures first US approval for soft chew analgesic - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Misbranded drugs seized in FDA operation - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Misbranded drugs seized in FDA operation - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

US legislators mull veterinary compound policies - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

US legislators mull veterinary compound policies - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

FDA funding to support US veterinary lab network - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

FDA funding to support US veterinary lab network - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Zoetis officially becomes biggest animal health firm - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Zoetis officially becomes biggest animal health firm - Animal Pharm - Your single source of animal health and nutrition business intelligence including latest news, analysis and data

Textbook Addresses Compounding and Vet Issues



Textbook of Veterinary Internal Medicine
By Stephen J. Ettinger, DVM, DACVIM and Edward C. Feldman, DVM, DACVIM
Chapter 160 – Compounding Drugs
Ron Johnson

One of the greatest challenges to veterinarians can be the availability of appropriate drug dosage forms that enable easier dosing of small dogs and cats and improve owner compliance. Although advances have been made with new drugs and dosage forms approved for veterinary medicine, clearly there is an unmet need with drug formulation options and dosages. As such, drugs approved in one animal species are frequently used in another species, including human-approved drugs. Compounded drugs can alleviate some of the drug-related issues facing veterinary medicine provided compounding is approached in a rational manner. There is little doubt that compounded drug formulations can offer effective and safe delivery options to veterinary patients. Support for this comes from the large number of pharmacies offering compounded drug products for veterinary patients and the increasing number of peer-reviewed journal articles that involve compounded veterinary …


UNDERSTANDING RISKS VERSUS BENEFITS WITH COMPOUNDED DRUGS
Pharmaceutical Issues
Compounding by medical professionals and pharmacists is not equivalent to the formulation of commercially manufactured products by reputable pharmaceutical firms. Drug formulation requires an understanding of the physical and chemical characteristics of the active pharmaceutical ingredient, along with the other agents (e.g., vehicles, excipients) used to produce the administered dosage form, in order to maintain the administered drug's effectiveness and safety profile. To this end, a compounded drug must possess adequate purity, potency, and demonstrate stability (shelf life) to maintain acceptable bioavailability (extent of systemic drug absorption) of the active pharmaceutical ingredient, but not produce toxicity or an ineffective preparation. However, for the vast majority of drugs compounded by veterinarians and most pharmacists, there is a lack of adequate pharmaceutical and clinical testing to ensure …

Transdermal Delivery of Drugs in Organogels
Transdermal administration of drugs for animals has the potential to be effective, safe, and can certainly enhance compliance. Absorption of drug via the transdermal route is primarily passive. As such, ideal molecules for this route of delivery are low molecular weight (<400 Daltons), lipophilic, and soluble in both water and oil.[10,11] Attention in veterinary medicine has focused on transdermal delivery of various drugs in organogels formulated for pulsed (single dose) therapy versus continuous release reservoirs (e.g., fentanyl patch (Duragesic).[12]
The growing list of drugs available in transdermal organogel formulations from compounding pharmacists includes antimicrobials, anticonvulsants, hormones, antineoplastics, prokinetic drugs, analgesics, and antiinflammatory agents. The vast majority of these compounded products are prepared in a pluronic lecithin organogel (PLO) vehicle. Lecithin is an emulsifying agent that forms a viscous gel when …
COMPOUNDING BY THE VETERINARIAN AND PHARMACIST: ROLES AND RESPONSIBILITIES
Compounding should be conducted in accordance with good pharmacy and compounding practices, relevant scientific literature, and applicable state laws. Pharmacy facilities used for compounding should have adequate room and equipment, be maintained in a clean and sanitary condition according to standard operating procedures in order to be effective, and prevent contaminations and errors. The USP 31-NF 26 contains a general chapter <1075> that addresses components of good compounding practices. These include responsibilities of the compounder, compounding facilities and equipment, recommendations for minimal training, and requirements for product packaging, labeling, and record keeping.[8]Importantly, there is now recognition of a separate veterinary compounding category by the USP-NF. The FDA Center for Drug Evaluation and Research has put forth a concept paper that evaluates drug products for human use that …
REFERENCES
1..  U.S. Code of Federal Regulations, Title 21—Food and Drugs: Part 530, Extralabel Drug Use in Animals, 1994.
2.. Center for Veterinary Medicine, US Food and Drug Administration Web site: Compounding of Drugs for Use in Animals.  Compliance Policy Guide. Ch 6 608.400. Available atAccessed August 2008 www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
3.. Geyer RE: Extralabel drug use and compounding in veterinary medicine. Food Drug Law J  1997; 52(3):291-295.
4.. Davidson G: The compounding controversy: what veterinarians should know to protect themselves and their patients. J Am Anim Hosp Assoc  2003; 39:13-17.
5.. Jordan DG: Pharmacist compounding vs veterinarian compounding: similarities and differences. J Am Vet Med Assoc  1994; 205(2):256-260.
6.. Riddell MG: AVMA's position on compounding for animals. Int J Pharm Comp  2005; 9(3):247-248.
7.. Papich MG: Drug compounding for veterinary patients. Am Assoc Pharm Sci  2005; 7(2):E281-E287.
8..  United States Pharmacopeia: Good compounding practices, The United States Pharmacopeia 31-National Formulary 26, Rockville, Md, 1075:500-503, 2008.
9..  United States Pharmacopeia: Pharmaceutical compounding-nonsterile preparations, The United States Pharmacopeia 31-National Formulary 26, Rockville, Md. 795:315-319, 2008.
10.. Marks SL: Transdermal therapeutics. J Am Anim Hosp Assoc  2003; 39:19-21.
11.. Riviere JE, Papich MG: Potential and problems of developing transdermal patches for veterinary applications. Adv Drug Deliv Rev  2001; 50:175-203.
12.. Davidson G: Update on transdermals for animal patients. Int J Pharm Comp  2005; 9(3):178-182.
13.. Bennett N, Papich MG, Hoenig M, et al: Evaluation of transdermal application of glipizide in a pluronic lecithin gel to healthy cats. Am J Vet Res  2005; 66:581-588.
14.. Hoffman SB, Yoder AR, Trepanier LA: Bioavailability of transdermal methimazole in a pluronic lecithin organogel (PLO) in healthy cats. J Vet Pharmacol Ther  2002; 25:189-193.
15.. Sartor LL, Trepanier LA, Kroll MM, et al: Efficacy and safety of transdermal methimazole in the treatment or cats with hyperthyroidism. J Vet Intern Med  2004; 18(5):651-655.
16.. Center for Drug Evaluation and Research, U.S. Food and Drug Administration: Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness.  Rockville, Md, FDA Concept Paper, 2000.
17.. Davis J: Compounding for creatures: what works. Int J Pharm Comp  1999; 3(3):182-185.

source and to preview textbook click here



Wednesday, June 26, 2013


WASHINGTON, June 26, 2013 /PRNewswire-USNewswire/ -- Professionals working in the pharmaceutical and biologics industries, especially lawyers, need to understand the current framework for creating and following current Good Manufacturing Practices (cGMPs), and the steep legal and regulatory consequences for failing to meet those standards. This one-day, Food and Drug Law Institute (FDLI), program is specifically tailored for lawyers, but appropriate for all drug and biologics stakeholders. The July 10 conference in Washington, DC will provide an overview of cGMPs (including revisions mandated by enactment of Section 711 of FDASIA), how FDA evaluates company compliance with cGMPs (including an examination of recent guidelines published by the International Conference on Harmonization and the latest developments on quality by design), and practical advice for how to remain current and compliant. Don't miss this opportunity to learn directly from FDA and industry experts about the most current methods for compliance and quality management.
Confirmed government participants: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Laura A. Rich, Chief, Regulations and Policy Staff, Office of the Center Director, Center for Biologics Evaluation and Research, Office of Medical Products & Tobacco, FDA; Douglas Stearn, Deputy Director, Policy and Analysis, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice.

Monday, June 24, 2013

AVMA July 2013 Issue Addresses Stability of Three Commonly Compounded Extemporaneous Enrofloxacin Suspensions

Stability of three commonly compounded
extemporaneous enrofloxacin suspensions
for oral administration to exotic animals
Enrofloxacin has been used in many exotic animal species, but
no oral suspensions of enrofloxacin are currently commercially
available. Thus, compounded formulations are often used. In
a study of the stability of 3 extemporaneous oral suspensions
of enrofloxacin mixed with readily available flavoring vehicles
and stored at room temperature in amber vials, the enrofloxacin
concentration in all 3 formulations was retained within acceptable limits (ie, 90% to 110% of the nominal concentration) for
up to 56 days. Subjectively, cherry syrup flavoring was better at
masking the smell and taste of enrofloxacin than was corn syrup
or liquid sweetener. See PAGE 85

quoted from here

Friday, June 21, 2013

New Federal Racehorse Drug Legislation Introduced

New Federal Racehorse Drug Legislation Introduced

RMTC Accredits First Two Laboratories

RMTC Accredits First Two Laboratories

Progress Cited on Racehorse Medication Penalty System

Progress Cited on Racehorse Medication Penalty System

AVMA passes 3 new policies on drug compounding


New policies offer guidance to legislators considering human/veterinary compounding laws
SCHAUMBURG, Ill.June 20, 2013 /PRNewswire-USNewswire/ -- The American Veterinary Medical Association's (AVMA) Executive Board recently approved three new policies to provide guidance on compounding to veterinarians and also legislators on Capitol Hill currently considering legislation on the issue.
"These policies are very important to our members and the animals they treat because veterinarians need compounded preparations in order to provide treatments to animals when drugs approved by the Food and Drug Administration (FDA) cannot be used," explains Dr. Douglas G. Aspros, president of the AVMA. "Our staff in Washington is currently meeting with members of Congress to ensure that compounded preparations are available to our patients when they need them. These policies will help in that educational process, not only by providing guidance to legislators considering compounding issues and legislation, but by informing our members on what is currently legal."
Compounded preparations are commonly used in veterinary practices across the country. Examples of drug compounding include mixing two injectable drugs, preparing an oral paste or suspension from crushed tablets, or adding flavoring to a drug to get a patient to accept the medication. These compounds can be created at the veterinary practices or through a prescription by a pharmacist. However, there is clear differentiation between compounding that is medically necessary in non-food patients and the very limited compounding that is used in food animal patients.
The Executive Board passed one new policy on veterinary compounding, in general, and two on compounding from bulk unapproved raw active ingredients. The new, general policy on veterinary compounding offers recommendations on how to compound in a way that minimizes the risk for adverse events, but also advocates for additional uses of compounded drugs. For example, the new policy recommends allowing veterinarians to maintain compounds in their office stock of drugs for urgent and emergent needs.
The other two policies, which address compounding from bulk unapproved substances, state that there are certain circumstances when bulk compounded drugs are useful and necessary. The policies establish very clear differentiation between medically necessary compounding needs in non-food animals from the very limited compounding in food animals.
The FDA and federal courts have held that compounding from bulk unapproved raw active ingredients is prohibited under federal drug law. The AVMA's two new policies on bulk compounding suggest how bulk compounding could be useful for veterinarians:
  • Compounding from Unapproved (Bulk) Substances in Non-Food Animals states that compounding from bulk is medically necessary in certain situations and should be allowed when the approved product is not commercially available (for example, during a drug shortage); when the approved product cannot be used to make the needed compound (for example, if the patient is allergic to the FDA-approved drug); or when there is no approved product from which to compound the needed preparation (for example, cisapride used for megacolon therapy in cats).
  • Compounding from Unapproved (Bulk) Substances in Food Animals states that compounding from bulk should be allowed specifically for and limited to euthanasia, depopulation and poison-antidote compounding. If adequate scientific information is not available to determine a withdrawal time, which is the known duration of time it takes for a drug to adequately clear an animal's system, the compound cannot be used in a food animal or the treated animal cannot enter the food supply.
The new AVMA policy on Veterinary Compounding replaces the Association's previous policy on the issue, and the Association's two new policies on Compounding from Unapproved (Bulk) Substances replace a previous policy on compounding from bulk substances.
For more information AVMA policies, please visit https://www.avma.org/KB/Policies/Pages/default.aspx, and for more information about veterinary compounding, visit https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx. For more information about the AVMA, please visit www.avma.org.
The AVMA, founded in 1863, is one of the oldest and largest veterinary medical organizations in the world, with more than 84,000 member veterinarians worldwide engaged in a wide variety of professional activities.
SOURCE American Veterinary Medical Association

Thursday, June 6, 2013

Great Veterinary Law Resources


Veterinary Law 


Chapter 6: Veterinary Medicine

Chapter of the FDA's Compliance Policy Guides dealing with veterinary medicine.  Explains how to follow FDA regulations related to veterinary medicine.

FDA and the Veterinarian

Website by the Center for Veterinary Medicine (CVM) on the practices and procedures of the FDA regarding veterinary medicine. Includes drug approval, classification, and reporting guidelines.  

State Veterinary Practice Laws

Map of the United States with detailed information on veterinary laws in each state. Can also search for laws by topic and species and find specific cases. Maintained by the Michigan State University College of Law.  

State Legislative Resources

Another map of the United States with state-specific information.  Links directly to state statutes, veterinary boards and associations, and other resources.  Compiled by the American Veterinary Medical Association.


General Veterinary Practice Issues 

A series of short articles summarizing general legal issues of veterinary practice, such as spay/neuter laws, pet damages, and veterinary malpractice suits. Maintained by the Michigan State University College of Law.  


Wednesday, June 5, 2013

Veterinary User Fee Bills Pass Congress, Await Obama's Signature

Veterinary User Fee Bills Pass Congress, Await Obama's Signature

Junk Faxes 101: Reminder Regarding Law, Marketing, and Unsolicited Faxes from Compounding Pharmacies

The Telephone Consumer Protection Act, 47 U.S.C. §227 (“TCPA”), (to read entire statute click here), prohibits compounding pharmacies from sending unsolicited materials advertising their compounded product to doctors, dentists, veterinarians, hospitals etc. Specifically, section 227 makes it a federal violation to use any telephone facsimile machine, computer, or other device to send an unsolicited advertisement (a "junk fax") to a telephone facsimile machine.  TCPA gives private citizens the right to sue to: (i) enjoin future transmissions, (ii) recover the greater of actual monetary damages or $500 in damages for each junk fax, or (iii) an injunction plus damages.  If the court finds that the sender willfully or knowingly violated the Act, the court may increase the award up to three times the amount of damages.  Note, however, that not every fax is a junk fax that violates the federal law.  To be subject to TCPA, a fax must be an "unsolicited ad."  An ''unsolicited advertisement'' is any material advertising the commercial availability or quality of any property, goods, or services that is transmitted to any person without that person's prior express invitation or permission.  Many states have also enacted anti-junk fax laws.  A number of good articles about this subject exist on the Internet to educate yourself more in this area. One to start with is Richard Keyt, Federal Junk Fax Law Prohibits Sending Unsolicited Ads To Fax Machines,docket and complaint (December 3, 2001).

As previously noted on this blog, a case is currently pending LOWLITE INVESTMENTS, INC., doing business as OLYMPIA PHARMACY, and JOHN DOES 1-10  That will be a very interesting to case to watch since it deals specifically with an unsolicited advertisement sent from a compounder to a veterinary clinic.



2013 AAVPT/CVM Animal Drugs in Feeds Workshop

Tuesday, June 4, 2013

2013 Custom Compounding Centers, LLC 5/15/13

2013 Custom Compounding Centers, LLC 5/15/13

Drug shortage prompts veterinarians to warn dog owners about tick-borne diseases this summer | GazetteNet.com

Drug shortage prompts veterinarians to warn dog owners about tick-borne diseases this summer | GazetteNet.com

AVMA accepting nominations for animal welfare symposium


The AVMA is giving the animal welfare discussion a much larger stage with its upcoming symposium called "Can You Hear Me Now? The Conversation."
To ensure that the symposium is filled with lively, productive discourse, the AVMA is seeking opinionated veterinarians and veterinary students to participate in the two-day event scheduled for Nov. 14-15, 2013, in Rosemont, Ill.
According to the AVMA, the event will provide participants with a thorough education about animal welfare issues, as well as give them the chance to generate ideas that can gradually be fleshed out into actionable strategies for the veterinary profession to advance animal welfare.
Symposium schedule
According to the AVMA, the symposium's first day will feature lectures on the scientific, social, political, and legal aspects of decision-making regarding making animal welfare decisions. The second day will see participants involved in roundtable discussions about welfare-related dilemmas affecting how animals are used and cared for across all sectors of the veterinary profession.
On Nov. 16 and one more unannounced date, a smaller group selected from among all participants will be invited to build on symposium discussions by forging a strategy that can lead to ongoing dialogue about animal welfare.
How to get involved
Veterinarians and veterinary students can nominate themselves their colleagues for one of the 150 available spots, although nominees must be AVMA members or student AVMA members. Nominees can come from sectors across the veterinary profession, including companion animal, farm, zoo, laboratory, and government, the AVMA said.
The association must receive nominations on or before July 1, 2013.
To nominate a colleague or yourself, download and fill out a nomination form fromwww.avma.org/theconversation. Send the nomination form along with a one-page resume or curriculum vitae to officeEVP@avma.org, or by mail to the AVMA Office of the Executive Vice President, 1931 N. Meacham Road, Ste. 100, Schaumburg, Illinois 60173.