June 01, 2006

 

 DEA revokes pharmacy's registration - June 1, 2006

 

Regulations for obtaining controlled substances addressed

posted May 15, 2006
 

Veterinarians were reminded of the regulations for obtaining compounded controlled substances when the Drug Enforcement Administration revoked Wedgewood Village Pharmacy's certificate of registration in April. The DEA reported that the Swedesboro, N.J.-based pharmacy was operating beyond the scope of its registration as a retail pharmacy and was acting as a manufacturer and distributor of controlled substances and listed chemicals.

Wedgewood President George Malmberg said the pharmacy has filed a motion asking the DEA to reconsider its decision. The pharmacy plans to appeal the decision to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C.

In September 2003, the deputy assistant administrator of the DEA issued an order to show cause to Wedgewood, which was then based in Sewell, N.J. Wedgewood was registered by the DEA as a retail pharmacy. The order alleged that Wedgewood was not acting as a traditional retail pharmacy, but was holding itself out as a compounding pharmacy that manufactured controlled substances without the appropriate DEA registration, in violation of the Controlled Substances Act and provisions of the Federal Food Drug and Cosmetic Act. The order alleged that the pharmacy was distributing controlled substances and listed chemicals without being registered with the DEA to conduct those activities.

The order also alleged that a DEA investigation of the pharmacy determined that Wedgewood was not maintaining complete and accurate records and inventories of the controlled substances that it handled, and was unable to accurately account for the bulk controlled substances and listed chemicals it had received.

The order proposed to revoke the DEA certificate of registration issued to Wedgewood, and to deny any pending applications for renewal of registration. The order alleged that the continued registration of the pharmacy would be inconsistent with the public interest.  

Veterinarians' part  

According to the DEA, evidence in the case demonstrated that Wedgewood was not preparing or compounding medications containing controlled substances on an individualized patient basis, which is required to be exempt from the definition of manufacturer under the CSA. Wedgewood was also not dispensing, but distributing controlled substances to individual practitioners. To dispense controlled substances, the pharmacy must deliver those substances to the patient or ultimate user. DEA indicated that by Wedgewood's own admission, and documented by the pharmacy's records, it was distributing controlled substances to practitioners throughout the United States for further dispensing by these practitioners.

 

Veterinarians need to understand that they can be held liable for dealing with pharmacies that don't follow DEA guidelines, said Douglas S. Collier, special agent with the DEA New Jersey Division. "They have to understand the law and be prepared that the liability will fall on them if there's a similar situation like we had with Wedgewood Pharmacy."

In accordance with the DEA, veterinarians may not issue a prescription to obtain controlled substances for general dispensing to patients. Instead, veterinarians should prescribe for a specific patient, and then have the pharmacy dispense that prescription to the client.

 

In-office use 

Veterinarians who are looking to obtain compounded controlled substances from a pharmacy for in-office use should treat the transaction as a distribution between two DEA registrants and keep the required records and security.
 

In-office use differs from patient-specific compounding in that the former is the means by which veterinarians obtain compounded controlled substances for administration in their offices to future patients in need. For example, veterinarians might need to have on hand a compounded stanozolol formulation to treat a debilitated dog or horse with a chronic disease.

In-office use is generally understood to include carriage in a veterinarian's medical bag or vehicle for administration to an animal in a field setting, but to exclude leaving a substance behind, or dispensing.

Many but not all states allow veterinarians to obtain compounded controlled substances from a pharmacy for in-office use. If a state does not allow in-office use, DEA regulations do not authorize veterinarian registrants in those states to receive compounded controlled substances from pharmacy registrants.

If their state will allow in-office use of compounded controlled substances, veterinarians can then request a distribution from the pharmacy. When ordering, the DEA indicated, veterinarians should not write prescriptions with their name or the clinic name as the patient. DEA regulations allow registered pharmacies to distribute—without being registered to distribute—a quantity of compounded controlled substances to registered veterinarians for administration to their patients, provided that:

  • the veterinarian is DEA-registered to administer that controlled substance
  • the pharmacy records that it distributed the controlled substances, and the recipient veterinarian records that they received the controlled substances
  • an official order form (DEA Form 222) is used for substances listed in schedule II. Schedule III to schedule V drugs may be ordered using an invoice
  • the total number of dosage units of all controlled substances distributed by the pharmacy during the calendar year does not exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the same calendar year

If a pharmacy believes that the proportion of all controlled substances that will be distributed will exceed five percent, the pharmacy must obtain a distributor registration rather than a practitioner registration.  

Keeping records

DEA requires both the pharmacy and veterinarian to keep the following record of the distribution:

 

  • controlled substance name
  • dosage form
  • quantity, including number of units or volume in each commercial container (eg, 30-tablet bottle or 3-milliliter vial) and number of commercial containers distributed or received
  • date
  • name, address, and DEA registration number of distributing practitioner (pharmacy) and receiving practitioner (veterinarian)

Veterinarians who receive a distribution and subsequently administer the controlled substance under a state-allowed, in-office use provision are required to keep customary records of controlled substance administration. The record should include the name and address of the client and patient to which the controlled substance was administered, date of administration, number of units or volume administered, and name or initials of the individual who administered it.

Compounded controlled substances should be included in the practice's initial and biennial inventory. DEA regulations require all controlled substance records to be retained for two years. States may impose additional record-keeping requirements.

"It's important for proper records keeping (of) the controlled substance or listed chemicals, and that's for your own safety," agent Collier said. "In case you do get reviewed by DEA, it's a helpful tool. ... You'll see with Wedgewood, the record keeping was just inadequate."

The DEA deputy administrator reported that investigators conducted an audit at Wedgewood of selected controlled substances and found overages and shortages.  

Securing controlled substances 

Security is also a concern. Compounded controlled substances should be stored in a locked cabinet or other secure storage container with limited access by the office staff members. If a theft occurs, Collier said, report the loss immediately to local law enforcement and the local DEA office.
 

"Some people say, 'we contacted the local law enforcement,' but ultimately, the DEA needs to know that information also because you do have a controlled substance that you signed for and are culpable for," Collier said.

Overall, Collier said if veterinarians have questions about regulations, they should visit the DEA Office of Diversion Control's Web site, www.deadiversion.usdoj.gov, for information.

For more information on the Wedgewood case, see the April 3 Federal Register notice, which is available by visiting www.access.gpo.gov/su_docs/fedreg/frcont06.html.