Our DEA registered veterinarian is leaving the hospital and a new director is taking over.  How do we transfer the drugs currently in the hospital to the new director?

The DEA must be notified of the transfer at least 14 days in advance.  Send written notice to the DEA Area Office in charge of that location.  The notification must contain:

1. The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor),
2. The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee),
3. Whether the business activities will be continued at the same location or moved to another location (if the latter, the address of the new location should be listed), and
4. The date on which the transfer of controlled substances will occur.

Unless the DEA notifies the transferring registrant that the ownership transfer cannot take place, on the day that physical custody of the drugs changes, BOTH the losing and gaining registrants must physically count the drugs as follows:

1. If the substance is listed in Schedules I or II, make an exact count or measure of the contents; or
2. If the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules, in which case he/she must make an exact count of the contents. (Note: although an estimated count is allowed, we strongly recommend that all drugs be counted to the exact tablet, capsule or milliliter during such transfers).

A written record of that count must be generated with the following information:

1. Date,
2. Name, address and DEA numbers of both the gaining and losing registrant,
3. Name of each controlled substance present and the form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter),
4. The number of units or volume of each drug,
5. The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials), and
6. The signatures of the registrants or their agents.

At the time of transfer, any records generated by the "losing" registrant should be transferred to the "gaining" registrant for maintenance.  The losing registrant is still responsible for the accuracy and completeness of those records, but the "gaining" registrant is responsible for maintaining those records for the required time and making them available if requested.  The gaining registrant should not make ANY changes to the losing registrant's records!

NOTE TO CORPORATE HOSPITALS

Regardless of what entity actually paid for the purchase of the drugs, the DEA considers those drugs the property of the registrant whose number was used to order them.  In most practice sale scenarios, the parties agree that the drugs are considered an asset of the business and are included in the sale so there is no discrepancy in their transfer.  However, in recent years the veterinary profession has seen an explosion in the number of corporate owned practices and non-profit organizations that rely on the individual DEA registrations of the medical directors at each location. 

In those cases, the transfer of the drugs may not be so clear if the relationship sours.  We strongly advise any entity or veterinarian in such a situation to have a written agreement between the parties outlining how such a transfer of ownership will be handled when the veterinarian leaves the practice for any reason.  An example of such an agreement can be found in Appendix A of The Complete Veterinary Practice Controlling Controlled Drugs Manual.

This procedure is spelled out in Title 21 FCR Section 1301.52(d)
https://www.ecfr.gov/current/title-21/part-1301/section-1301.52#p-1301.52(d)

 

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Did You Know...?

Regardless of what entity actually paid for the purchase of the drugs, the DEA considers those drugs the property of the registrant whose number was used to order them.

The Complete Veterinary Practice Controlling Controlled Drug Manual contains detailed instructions on complying with the Controlled Substance Act and it's regulations.

Click here to read more about this valuable reference.