In December 1999, concerns uncovered during Food & Drug Administration (FDA) inspections of Ganes Chemical, Inc. led the company, which is the only U.S. manufacturer of the raw ingredient sodium pentobarbital, to temporarily halt production. The FDA cited Ganes Chemical Company for problems with the manufacturing process and sterility of the drug. These problems never affected the efficacy or performanace of the sodium pentobarbital when used to provide humane euthanasia. Now, according to the FDA, Ganes Chemical has corrected the manufacturing violations uncovered by FDA. However, some distributors of sodium pentobarbital may still be having trouble filling orders completely and some shelters are suffering. Vortech Pharmaceuticals is currently filling orders for sodium pentobarbital. The HSUS strongly discourages shelters from resorting to alternative methods of euthanasia during this shortage. Instead, The HSUS is asking shelters that can spare some of the drug to share their supply with shelters in need. The following instructions provide a legal method whereby shelters can "sell" a few bottles of sodium pentobarbital to a neighboring shelter in states where it is permitted. If shelters work together, along with members of the veterinary community, this situation can be resolved. Please be sure to check with your state Board of Pharmacy to make sure the transfer of sodium pentobarbital is legal in your state. If you need further assistance, please contact HSUS Animal Sheltering Issues staff members Betsy McFarland or Kate Pullen at 202-452-1100; or e-mail bmcfarland@hsus.org or kpullen@hsus.org. If it is legal in your state, it is essential that you follow this protocol to be in compliance with Drug Enforcement Agency (DEA) regulations: Schedule II Drugs (Fatal Plus-solution/powder, Sleepaway, Euthanasia-6, and Socumb) If you have Schedule II drugs, you may "sell" bottles to another shelter in need by following these steps: - The shelter receiving the drug must complete DEA Form 222 and send copies 1 and 2 of the form to the shelter that will be providing the drug(s).
- The providing shelter then must complete the left side of the form to include the quantity being "sold" and the date of "sale."
- The green copy (copy 2) of the form must be sent to the local DEA office as a permanent record of the transaction.
The same process must be followed when the receiving shelter replaces the donated drug(s). Schedule III Drugs (Beuthanasia-D and Euthasol) The transfer of Schedule III drugs can be handled using a standard invoice process showing the number of bottles "sold"; both the buyer's and seller's names, addresses, and DEA numbers; the date of the sale; the strength of the drug; the name of the product; and the size of the bottle (in milliliters). Both parties involved in the transfer will need to file a copy of the invoice as part of their records for two years.
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