In 2011 the Risks Associated With Veterinary Compounding Pharmacy Choices Was Pointed Out--Confirming One Must Know the Compounding Pharmacy They Are Doing Business With

Risks Associated with Veterinary Compounding Pharmacy Choices (AAEP 2010)

By Nancy S. Loving, DVM

Updated: Wednesday, February 9, 2011 9:00 AM
Posted: Wednesday, February 9, 2011 12:00 AM

Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/61240/risks-associated-with-veterinary-compounding-pharmacy-choices-aaep-2010#ixzz2P3Ge22ds

Virginia Board of Veterinary Medicine Use of Compounded Drugs in Vetererinary Practice Adopted Februrary 7, 2013-includes office use

Virginia Board of Veterinary Medicine

Use of Compounded Drugs in Veterinary Practice

Applicable Laws

§ 54.1-3401. Definitions.

As used in this chapter, unless the context requires a different meaning:

"Compounding" means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed prescribing patterns; (ii) by or for a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (§ 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or A 19 of § 54.1-2901, or a person supervised by such practitioner or a licensed nurse practitioner or physician assistant pursuant to subdivision A 4 of § 54.1-2901 shall not be considered compounding.

 

§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.

A. A pharmacist may engage in compounding of drug products when the dispensing of such compounded products is (i) pursuant to valid prescriptions for specific patients and (ii) consistent with the provisions of § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.

Pharmacists shall label all compounded drug products that are dispensed pursuant to a prescription in accordance with this chapter and the Board's [Pharmacy] regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.

B. A pharmacist may also engage in compounding of drug products in anticipation of receipt of prescriptions based on a routine, regularly observed prescribing pattern.

Pharmacists shall label all products compounded prior to dispensing with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy's assigned control number that corresponds with the compounding record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (iv) the quantity.

C. In accordance with the conditions set forth in subsections A and B, pharmacists shall not distribute compounded drug products for subsequent distribution or sale to other persons or to commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding takes place.

A pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.

A pharmacist may also provide compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their professional practice, either personally or under their direct and immediate supervision.

Pharmacists shall label all compounded products distributed to practitioners for administration to their patients with (i) the statement "For Administering in Prescriber Practice Location Only"; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility's control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (v) quantity.

E. Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.

J. Practitioners who may lawfully compound drugs for administering or dispensing to their own patients pursuant to §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.

Guidance

Q: May a veterinarian prescribe a compounded drug product?

A: A Virginia licensed veterinarian may prescribe a compounded drug product by preparing a valid prescription pursuant to federal and state laws and regulations for an individual patient with which there exists a valid veterinarian-client-patient relationship. The client may obtain the compounded drug product from a pharmacy of their choice that is properly licensed by the Virginia Board of Pharmacy. The payment arrangements for a prescribed compounded drug product are not under the purview of the Board of Veterinary Medicine. However, a pharmacist must be compliant with the Virginia Board of Pharmacy regulation, 18VAC110-20-390(A), which states “A Pharmacist shall not solicit or foster prescription practice with a prescriber of drugs or any other person providing for rebates, ‘kickbacks,’ fee-splitting, or special charges in exchange for prescription orders unless fully disclosed in writing to the patient and any third party payor.”

Q: May a veterinarian obtain compounded drug products from a pharmacy for administration in their office?

A: Yes, a Virginia licensed veterinarian may obtain compounded drug products from a pharmacy that is properly licensed by the Virginia Board of Pharmacy for administration in the course of their professional practice. Pursuant to Virginia Code § 54.1-3410.2(C) the pharmacist is required to label the compounded drug product with the statement “For Administering in Prescriber Practice Location Only.”

Q: May a veterinarian dispense a compounded drug product?

A: A veterinarian may dispense a compounded drug product if compounded by the veterinarian pursuant to Virginia Code § 54.1-3410.2(J).

Q: May a pharmacy provide compounded drug products to a veterinarian for the veterinarian to dispense to his patients?

A: No, Virginia Code § 54.1-3410.2 prohibits pharmacists from distributing compounded drug products for subsequent distribution or sale to other persons.

Q: What is the penalty for a licensee of the Virginia Board of Veterinary Medicine who is found to be dispensing compounded drug product purchased from a pharmacy?

A: The licensee may be subject to disciplinary action.

source found here:  

1. 54.1-3410.2. Compounding; pharmacists' authority to compound ...

   https://www.dhp.virginia.gov/vet/guidelines/150-5.doc

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   Feb 7, 2013 – Use of Compounded Drugs in Veterinary Practice ... as incident to, research, teaching, or chemical analysis and not for sale or for dispensing

Question of the Day: Should Compounding Sales Reps or Compounding Marketing Reps Be Paid a Salary or a Commission? Have Salaries Dropped as Low As This Index Shows For These Jobs

Average Salary of Jobs Matching Your Search

In USD as of Mar 30, 2013		15k	30k	45k
Source from Indeed jobs.com Compounding Pharmacy Sales Representative in Katy, TX	$27,000

Average Compounding Pharmacy Sales Representative salaries for job postings in Katy, TX are 14% lower than average Compounding Pharmacy Sales Representative salaries for job postings nationwide.

After fungal meningitis outbreak, agencies do battle with pharmacies ...

By Maggie Fox, Senior Writer, NBC News

The Food and Drug Administration says it doesn’t have the power it needs to control compounding pharmacies that have expanded out of their traditional one-patient-at-a-time role to making mass drugs.

But consumer advocates say a recent crackdown by the agency shows it most certainly can – and should. A spate of recent FDA inspections have shown that the dirty conditions that led to an outbreak of fungal meningitis that killed 51 people and sickened more than 700 are anything but rare at pharmacies that mix up what are supposed to be “sterile” injectable drugs.

“We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk,” FDA commissioner Dr. Margaret Hamburg writes in her latest blog entry. “Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.”

That's a big step up from the previous pace, when FDA might inspect a facility, write a letter, and wait a few years before following up. Hamburg estimates there are more than 7,000 compounding pharmacies in the U.S. "We had a list of facilities we have been keeping our eye on," says FDA spokeswoman Erica Jefferson. The FDA sent Medi-Fare Drug & Home Health Center, Inc. of Blacksburg, S.C., a warning letter earlier this month, pointing out both that it wasn’t preparing products to match prescriptions and that it had “serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk.”Other FDA reports this year have pointed out patches of rust at one compounding pharmacy in St. Petersburg, Fla. and sloppy sterility practices at one in Swedesboro, N.J. It's about time, say some. “That’s the type of activity we were calling for,” says Dr. Michael Carome of the consumer group Public Citizen, which is agitating for the FDA to do more to regulate compounding pharmacies. Public Citizen has argued that the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act.

Luckily, so far, there’s not been another outbreak of illness like the one traced to the New England Compounding Center (NECC), in which 51 people have died of fungal meningitis and more than 700 infected after receiving contaminated injection steroids.

“We haven’t seen any other large-scale scale compounding outbreaks,” Dr. Michael Bell, acting director of the division of health care quality promotion at the Centers for Disease Control and Prevention, told NBC News. He says there’s a steady stream of requests from states to check, however.

The FDA is openly telling the pharmacies and drug manufacturers it regulates that things have changed since the outbreak tied to NECC. Hamburg was questioned by both House and Senate committees about how the incident could even have happened.

“They appear to have the authority to take actions against companies that engage in drug manufacturing,” Carome said. “What we are going to have to wait to see is will they stand behind the citations of violations they are making,” he added. “That is what they have failed to do previously. Hopefully it’s not just for show.”

Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. But the line between what is a manufacturer and what is a compounding pharmacy can be blurry.

Compounding pharmacies are supposed to mix prescriptions one at a time, on a per-patient basis. But there’s so much demand for special formulations that hundreds of these compounders have started large-scale production. Now, they closely resemble drug manufacturers – but without the very strict oversight and long list of sterility requirements that manufacturers must follow.

Jefferson says the crackdown hasn't gone entirely smoothly. "We still run into situations where a facility has not cooperated with us," she said. "We might not be able to take samples. They might say, 'No, you can't see this.'" Then FDA has to seek help from state authorities.

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