Q - What is MNVD (or MNVP)?
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
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