Friday, July 13, 2012

Inspection Report for Veterinary Practices in Virginia

In May 2012, Virginia revised its inspection report for Veterinary Practices operating in its state.  That report can be found here.  The report contains the following section:

Bulk Reconstitution of Injectable, Bulk Compounding or Prepackaging
 17  Major 18VAC150-20-190(J) Veterinary establishments in which bulk reconstitution of injectable, bulk compounding or the prepackaging of drugs is
performed shall maintain adequate control records for a period of one year or until the expiration whichever is greater.
 18 Major 18VAC150-20-190(J) Reconstitution, compounding and prepackaging records shall show the following:
1. Name of the drug(s) used;
2. Strength, if any;
3. Date repackaged;
4. Quantity prepared;
5. Initials of the veterinarian verifying the process;
6. Assigned lot or control number;
7. Manufacturer’s or distributor’s name and lot or control number; and
8. Expiration date.
Guidance: When drugs are taken from a stock bottle and put into another container prior to prescribing in anticipation of future dispensing, the drugs are considered to be prepackaged. Dispensing, labeling and recordkeeping requirements must be followed when prepackaging drugs. 
Transferring drugs to another container can affect the stability of the product. Expiration dates play an important role in maintaining the stability of a drug. The expiration date for a drug prepackaged is the same as the original stock bottle or is one year from the date of transfer whichever is less. Drugs should be stored under conditions which meet the United States Pharmacopeia and the National Formulary (USP-NF) specifications or manufacturers’ suggested storage for each drug.

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