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

Register Online!

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