The Texas Board of Veterinary Medical Examiners adopts an amendment to §573.43, regarding Controlled Substances Registration. The amendment is adopted without changes to the proposed text as published in the September 11, 2015, issue of the Texas Register (40 TexReg 6024) and will not be republished.

The amendment requires all practitioners to have a Drug Enforcement Administration (DEA) federal controlled substance registration if the practitioner administers, prescribes, dispenses, delivers, or orders delivered controlled substances. SB 195 provided that to manufacture, distribute, prescribe, analyze or dispense a controlled substance, a person must have a DEA federal registration. Dispensing includes prescribing and administering. Under SB 195, the practitioner is allowed to only possess without a DEA controlled substances registration. DEA has informed Board staff that it has never considered other practitioners within a clinic an "agent" for purposes of the agent exemption from DEA registration. DEA has stated that their definition of agent is someone who works on behalf of or at the direction of the practitioner. Another practitioner examining his or her own patients and not acting under the specific direction of another practitioner must be registered. No other health profession agency in Texas is permitting other practitioners to serve as agents under another practitioner's DEA registration. The idea is that a practitioner is acting independently and should therefore be responsible for their own controlled substances and any potential diversion of such controlled substances. Under the previous rule, every practitioner was required to have a Department of Public Safety (DPS) controlled substance registration. Under SB 195, the DPS controlled substances registration is discontinued as of August 31, 2016. With the DPS controlled substances registration going away, the Board was also concerned that there would be certain number of practitioners that would now have no controlled substance registration. There is a large and growing problem of diversion of controlled substances in society and this is becoming a larger problem in the veterinary community.

The rule is going into effect on September 1, 2016 in order to allow licensees plenty of time to get their DEA controlled substances registration and because the law on DPS controlled substances registration does not expire until August 31, 2016.

Two comments were received agreeing with the proposed amendments. One commenter noted that the DPS controlled substances registration was redundant so everyone should have a DEA controlled substances registration now that the DPS controlled substances registration is going away. Another commenter noted that each practitioner, whether working in a group practice or as a sole practitioner, is an independent entity and should possess all of the credentials for said practice. This commenter is concerned about blurring the lines as to who would be responsible for actions of individual practitioners. The Board agrees and believes this is the policy behind the recent legislation, SB 195.

Twenty comments were received against the adoption of the amendments to the rule, including from the Texas Veterinary Medical Association (TVMA). The comments were mostly concerned with the increased cost to practitioners. The Board believes that while this is a significant expense for approximately 2200 licensees, this is required by SB 195 which passed in the last legislative session. There is a large and growing problem of diversion of controlled substances and this legislations and the amendments to this rule are in an effort to address this societal problem. Board staff also spoke with DPS staff and DPS stated that the new statutory language was replacing DPS controlled substance registration with the DEA controlled substances registration. TVMA and a few other commenters also commented that the Board staff is incorrectly interpreting the language set out in SB 195. The Board disagrees as SB 195 was passed by the Texas Legislature replacing the term for DPS registrant with the term for DEA registrant throughout the statutory language. TVMA highlights that there is language added in SB 195 stating that "except as otherwise provided by this chapter, a person who is not registered with or exempt from registration with the federal DEA [a registrant], may not manufacture, distribute, prescribe, possess, analyze or dispense a controlled substance in this state". This, however, does not change that there is a later clear statement that only possession of controlled substances is allowed without a DEA registration. The Board also notes the systemic replacement of DPS registrant with DEA registrant throughout SB 195 as proof of legislative intent as well as the testimony at the legislative hearings on SB 195. The legislative sponsors for the bill testified that the DPS registration was completely duplicative of the DEA registration. The Texas Association of Business testified in favor of the bill stating millions of dollars are spent by businesses in the state on lost time from employees using diverted drugs and on health insurance costs due to the increasing number of employees using diverted drugs and their potential addictions from such use. One witness in favor of the bill testified that the DEA license process is efficient and that the DPS process would take months to cancel a license. No representative from the veterinary profession testified at the legislative hearings on this legislation. DEA has stated to Board staff that a person may not work under another person's registration and if DEA were to inspect a veterinarian's office they would require a veterinarian, which used controlled substances but was working under another licensee's DEA controlled substances registration, to get their own DEA registration. DEA has also provided guidance on the term agent or employee and they state that this is meant for individuals who could not otherwise get their own DEA registration. There were a few comments that are concerned that relief veterinarians have to change their address with DEA every time their practice address changes that this will be burdensome and require a new registration with DEA. The Board disagrees as DEA has stated that while a new registration is needed with a change of practice address, there is no additional fee and the process is expedited. There was also a commenter that stated every licensee would be required to have a DEA license. The Board disagrees as the DEA registration is only required if the practitioner is using controlled substances. SB 195 is clear that only possession of controlled substances is allowed without a DEA registration. There were also a few commenters who believe the cost is $731 per year is the cost of the DEA registration. According to DEA, the cost is $731 every 3 years, or about $244 per year. There were also a few commenters who stated that the increase in cost would mean that they as a licensee would then not prescribe pain medications or do surgeries when necessary due to the increase in cost. The Board disagrees as there is still a standard of care and if pain medications or surgeries are required then the animal would need to be referred to a licensee with a DEA registration so as to receive appropriate medical care.

The rule goes into effect September 1, 2016.

The amendment to §573.43 is adopted under the authority of the Veterinary Licensing Act, Occupations Code §801.151(b) which states that the Board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession.

Texas Occupations Code, Chapter 801, is affected by the adoption.