Statement on Veterinary Compounding from the Veterinary Council in New Zealand

Statement on Compounding Veterinary Medicines

This statement should be read in conjunction with:

• Paragraph 6 of the Veterinary Medicines section of the VCNZ Code of

Professional Conduct and related explanatory notes

• MAF Guidance on Developing a Documented System to meet conditions of

exemption from registration for Compounded Veterinary Preparations under the

ACVM (Exemption) Regulations 2011

Definitions

Compounding means to combine ingredients (for example, generic chemicals or

biological compounds or trade name products) to prepare a medication to be

dispensed to a person to treat an animal. To prepare means not only the process of

combining ingredients in an appropriate manner for the intended purpose but also

placing the medication into appropriate packaging with appropriate labelling to allow

it to be dispensed to and used by a person other than the veterinarian who

compounded it.

Practices that are also included but do not strictly fit the above definition of

compounding are:

• decanting and breaking down trade name products into smaller quantities when

there is no change in the product itself

• reconstituting trade name products, and

• preparing medications to be used immediately by the veterinarian who prepares

the medication.

Compounding Classes--

Compounding Courses

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Aseptic Technique CompoundingMay 10-11
August 15-16

Contemporary Prescription Compounding

Jun 11-12

Basic Compounding for Pharmacy Technicians

June 19-20

Basic Veterinary Compounding

July 31 - Aug 1

High Risk Sterile Compounding

August 7-8

Women's Health Compounding

September 27-28

What The Proposed Federal Legislation Has to Say About Compounding from Bulk- Vets What Do You Have to Say? You Need to Be Voicing Your Opinions on How This Will Effect You!

Bulk Ingredient Qualifications and Restriction on Wholesaling

The bulk requirements in current section 503A are preserved, with one modification.  Current law requires that any drug compounded from bulk must use bulk active pharmaceutical ingredient that 1) either complies with an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, is part of an FDA-approved drug, or appears on a list established by the Secretary; 2) is manufactured in a registered establishment; and 3) is accompanied by a valid certificate of analysis.  The revised section 503A would permit the Secretary to identify a drug that only has an applicable USP or NF monograph as not suitable for compounding following the publication of the reasoning and consideration of comments submitted to a docket open for at least 30 days. Inactive ingredients also must comply with USP or NF.

If a drug is being compounded for a minor animal species, the same requirements on bulk chemicals apply. However, if a drug is compounded for a non-food major species or food-producing animal, compounding from bulk can only be performed if FDA has listed that bulk ingredient. The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats. Minor animal species are all other species.

Compounded drugs may only be sold by the entity that compounded that product, and all must be labeled “not for resale”. It is a prohibited act to resell a product labeled “not for resale”. 

quoted from the Senate's section by section paper.

Do vets have a problem with this proposed new federal legislation?  If so, you need to get your comments submitted by the May 3, 2013 deadline.

ASHP Statement on HELP Committee Proposed Pharmaceutical Compounding Bill April 30th, 2013 John Buck

The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.

“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a “compounding manufacturer” that would be overseen by the Food and Drug Administration (FDA).”

The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.

The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.

ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.

Source: ASHP

Question of the Day: 4/30/2013 Doesn't Congress Needs to Listen to the Experts in the Field--the Ones Who Deal with the Real World of Compounding?

In reading articles recently posted, it is apparent that there is still much misunderstanding about compounding, compounding pharmacies and the state of the law.  If as some commentators say, "the FDA dropped the ball"  then why is there a need for new federal legislation giving them authority over some compounders if in fact they had authority over all compounders or at least the group recently inspected by them?  If the FDA did not drop the ball  and thus did not have authority to regulate, then isn't it true the states dropped the ball and that there may be a need for additonal federal legislaton of some kind?

Doesn't it make sense for Congress to get more input from the people who actually deal with compounding everyday?  Why not call leading pharmcist in compounding and knowledgeable marketing directors that deal with the realities of compounding to testify before them and get their input in how the federal legislation should be drafted?

Health Canada Reviews Compounding Regulations Following Drug Scare

After reports of more than 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities, allowing admixing to continue under strict direction.

This article is viewable by subscribers only. 

International Regulatory Compliance Blog--Compounding Laboratories & Pharmacies – How Safe Are Your Products?

To read this blog 

click here

Will Senate fix compounding pharmacy oversight this time?

The 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.

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 outbreak tied to tainted injections made by the New England Compounding Center.

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.

continue reading here

BREAKING NEWS: TN governor signs bill easing compounding--No Requirement Anymore for Patient-Specific Prescription

Gov. Bill Haslam has quietly signed into law a bill that eliminates a Tennessee requirement that pharmacists have a patient-specific prescription before dispensing a specially compounded drug.

The measure, which was backed by the Tennessee Pharmacists Association and sponsored by two legislators who are licensed pharmacists, comes in the wake of a nationwide fungal meningitis outbreak blamed on a Massachusetts drug compounding firm.

Alexia Poe, spokeswoman for the governor, said state Health Department officials worked with legislators to put in safeguards to ensure patient safety.

Those provisions include a requirement that pharmacists doing compounding filequarterly reports with the state on the volume of compounded drugs they are producing. That reporting requirement, however, does not apply to hospital pharmacies.

continue to read here

How a Shadow Drug Industry Tries to Avoid Regulation

How a Shadow Drug Industry Tries to Avoid Regulation