Controlled substances significantly increase a practice’s compliance obligations, but it is nearly impossible to practice without them. Drugs—and certain chemicals used to make drugs—are classified into five distinct categories known as schedules (I-V), depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the abuse potential decreases, the drug schedule number increases, with Schedule V drugs representing the least potential for abuse.
The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States. DEA law enforcement has three divisions:
- Enforcement: the most important division
- Diversion: investigative power, but no law enforcement power without calling in the enforcement division.
Compliance with controlled sub stance regulations is essential. Vet practices are often targeted for theft of controlled substances, and these drugs can cause significant harm in society when they are used outside of the law. For example, ketamine has been used in cases of date rape.
A vet practice might come under the DEA spotlight through a complaint by a disaffected employee, the arrest of an individual with controlled drugs that were improperly dispensed, or a reported loss of large amounts of controlled substances.
Usually if a practice gets in trouble, it becomes a regulatory rather than a criminal prosecution. If a practice is visited by one DEA group (Diversion) in the morning and another (Enforcement) in the afternoon, this means that the regulatory division has called the enforcement division, and the situation is serious. If any false information is given to the Diversion division by practice representatives, or the Diversion division personnel have reason to believe that full cooperation is not being given by the veterinarian, the Enforcement division will be called.
If your practice discovers an issue with controlled substance compliance or theft, utilizing a DEA consultant is recommended. Most are former DEA employees who can provide valuable advice. It is best that any request for services of a DEA consultant originate from the practice’s attorney, so that there will be attorney/ client privilege about the findings of the consultation and deficiencies found.
Each practice is responsible for understanding and complying with the regulations described in Title 21 Code of Federal Regulations, PART 1300-END, which can be found at www.deadiversion.usdoj.gov/21cfr/cfr/index.html.
The following are some highlights from these regulations:
1. DEA Registration—Because each DEA registration requires separate control substance (CS) recordkeeping sites, separate storage of controlled substances and absolutely no co-mingling of controlled substances or controlled substance records, one option for practices is to have a “clinic” registration. All veterinarians are then listed and referenced under the clinic registration as -1, -2, etc. A simpler option is to have one registrant who acts as the primary registrant with subordinate agents. The primary registrant then has responsibility to supervise his agents, as he or she is responsible for their conduct. Remember: He/she is personally and fully responsible.
2. Background Checks—By law, practices are obligated to do background checks on all persons with access to controlled substances. Each person to be investigated needs to sign a written waiver before the background check is conducted. You can ask the local DEA diversion officer or your local sheriff or police department to do a NADDIS and NDIC check, and you should have a written policy in place regarding this.
3. Leadership—A Controlled Substance Officer (CSO) needs to be appointed for every practice. This person is responsible for training new employees about controlled substance policies and protocols, keeping biennial inventories and maintaining accurate records of controlled substances and Forms 222, etc.
4. Technicians—Federal law does not permit technicians to administer controlled substances. Some states have laws stating that technicians are “practitioners,” but the federal law supersedes state laws.
5. Biennial Inventory—This is a physical count documented in an exact way that is required every two years. Federal law requires keeping records for two years, and state laws vary. It is important to be aware of your state laws.
6. Form 222—Form 222 is used to order CII controlled substances such as sodium pentobarbital. The Form 222 must be signed personally by the registrant unless that person has a written Power Of Attorney on file. Upon receipt of the CII substances, the acknowledgement of receipt with the date must be made on the Form 222. The Form 222 must be stored separately and as securely as the controlled substances.
7. Destruction—When you have defective or expired controlled substances, one option is to directly destroy the substance, provided the registrant has at his or her registered site a method of destruction that is legal under local, tribal, state and federal law. The method must render the substance “non-retrievable,” which is defined as “permanently altering the substance’s physical or chemical condition or state through irreversible means so as to make it unavailable and unusable for all practical purposes” or “when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled-substance analog.”
If a registrant opts to destroy the substance on-site, the job may not be done solo. The regulations state: “Two employees of the registrant must handle or observe the handling of any controlled substance until the substance is rendered non-retrievable.” Mixing controlled substances with kitty litter or coffee grounds and disposing of the amalgam in the garbage does not meet the “non-retrievable” standard.
8. Reverse Distributions—These are used for defective or expired controlled substances. By using a reverse distributor company, registrants may dispose of unwanted product for a fee. In the case of returns or recalls, they can send the controlled substance to the individual, manufacturer or representative of the manufacturer from whom it was obtained. There are often different state and federal regulations. You can read more at news.vin.com/vinnews.aspx?articleId= 33945.
9. Separate Invoices—Distributors that ship controlled substances should send packing information on a separate invoice, because controlled substance invoices must be kept in a separate file. Make sure to note the date on which the shipment is received and the quantity that is included in the order.
10. Dispensing—In order to dispense controlled substances, one must write a controlled substance prescription. In some states, controlled substance prescriptions must be reported online within 24 hours. Dispensing without a prescription or pretending the drug was administered is grounds for criminal enforcement.
11. Loss or Theft—You must file Form 106 for all thefts and for “significant” losses within 24 hours. Form 106 is found online and must be completed and submitted electronically.
12. Employment Screening—It is the position of DEA that the obtaining of information from prospective employees about conviction of crimes and unauthorized use of controlled substances is vital to fairly assess the likelihood of an employee committing a drug security breach. It is, therefore, assumed by the DEA that the following questions will become a part of an employer’s comprehensive employee screening program. Failure to do so can cause the DEA to judge that your practice is not serious about compliance with the regulations.
a. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor, or are you presently charged (formally) with committing a criminal offense? Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial. If the answer is “yes,” furnish details of conviction, offense location, date and sentence.
b. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician?
13. Responsibilities to Report Drug Diversion—Employees who have knowledge of drug theft or diversion from their employers have an obligation to report such information to their employers. Employers have a responsibility to treat such information as confidential and to take all reasonable steps to protect the confidentiality of the information and the identity of employees furnishing information.
Failure to report drug theft or diversion information should be a critical factor in determining an employee’s continued employment. Employees who possess, sell, use or divert controlled substances not only subject themselves to state or Federal prosecution for any illicit activity, but should also become the subject of independent action regarding their continued employment.
Training files should include evidence of all background checks done on each employee with actual or potential access to controlled substances. They should also contain an acknowledgment from the employee that he or she has been trained in and understands the Standard Operating Procedures (SOP) relative to all aspects of controlled substances.
Regulations require that an employer advise each employee in writing of his or her obligation to report any instance of actual or suspected diversion of a controlled substance. This written notification should be part of each employee’s training file.
Careful attention to compliance with the regulations concerning controlled substances is not only the law, but also an obligation to protect the public. Taking this responsibility seriously is an essential part of ethical practice.
- Title 21 Code of Federal Regulations, https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html
- Practitioners Guide: deadiversion.usdoj.gov/pubs/manuals/pract/index.html
- Security Guide: deadiversion.usdoj.gov/pubs/manuals/sec/index.html