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Breaking Regulatory News
New!! Veterinarian Agrees To Pay $15,000 Settlement To Resolve Allegations Of Inadequate Recordkeeping Of Controlled SubstancesBOSTON – A Dedham veterinarian has agreed to resolve allegations that he maintained inadequate records of controlled substances, improperly stored controlled substances at his office and residence, ordered controlled substances without a Drug Enforcement Administration (DEA) registration, and failed to report he was on probation on his DEA registration forms.
Read more here: https://www.dea.gov/press-releases/2022/09/21/dedham-veterinarian-agrees-pay-15000-settlement-resolve-allegations
Former Veterinarian Pleads Guilty to Drug Charges
LYNCHBURG, Va. – Former veterinarian pleaded guilty to a pair of misdemeanor drug charges related to his diversion of hydromorphone, an opioid drug also known under the trade name of “Dilaudid.”
Read more here: https://www.justice.gov/usao-wdva/pr/former-veterinarian-pleads-guilty-drug-charges
DEA will stop accepting printed, mail-in application or renwal forms after May 11, 2022
Starting on May 11, 2022, the DEA will require all applications for DEA registrations, and renewal of those registrations, to be submitted online.
https://www.federalregister.gov/documents/2022/04/11/2022-07570/requiring-online-submission-of-applications-for-and-renewals-of-dea-registration
DEA Updates Order Form Requirement for Schedules I & II Drugs
The DEA released the final rule redesigning the DEA Form 222 order form. When the DEA first proposed the change in 2019, they allowed the old triplicate order forms to be used until October 30, 2021. Now the old triplicate versions of the form are obsolete and no longer useable. Unused triplicate DEA Form 222’s should be returned to the DEA for destruction.
https://www.ecfr.gov/current/title-21/chapter-II/part-1305#1305.20
Now would be a great time to order your own copy of The Complete Veterinary Practice Controlling Controlled Drugs Manual! See the box on the right of this page.
On August 10, 2020 OSHA issued a Letter of Interpretation relating to the exclusive use of on-line or virtual training materials to satisfy requirements in the regulations. Although the letter ultimately said that each situation would have to be evaluated based on the individual circumstances, but they did give some insight into their thinking. In the memo, Mr. Patrick J. Kapust, Acting Director for the Directorate of Enforcement Programs writes:
" Employers need to examine the standards applicable to their workplaces and determine whether the training tools (such as online or virtual reality) they are using advance their employees’ overall comprehension and understanding of workplace hazards.
Effective safety and health training should include hands-on instruction and exercises, which provide employees the opportunity to become familiar with protective measures such as personal protective equipment, and safe workplace practices. For example, the purpose of hands-on training in the donning and doffing of personal protective equipment is two-fold: first, to ensure that workers have an opportunity to learn by experience and second, to assess whether workers have learned to use the protective gear competently."
Here's a link to that interpretation letter:
https://www.osha.gov/laws-regs/standardinterpretations/2020-08-10
It's long been our position that training aids such as videos, Powerpoint slideshows and even our own training workbooks are great tools for the trainer but can never REPLACE the trainer!
Here's a link to an excellent OSHA Pamphlet entitled Resource for
Development and Delivery of Training to Workers:
https://www.osha.gov/Publications/osha3824.pdf
And if safety training videos
are something you find useful, we're pretty partial to the AAHA
BeSafe! veterinary specific videos (Hint, Phil is the author of the
content so that's why we like them so much!)
Click here to learn about the AAHA BeSafe videos!
For 2022, OSHA increased the minimum
penalty for a Serious Violation to $1,036. The maximum fine
per infraction has been raised to $14,502 for all types of
violations, including Serious, Other than Serious, Willful or
Repeated AND Posting requirements.
https://www.osha.gov/memos/2022-01-13/2022-annual-adjustments-osha-civil-penalties
In 2021 the minimum penalty for a
Serious Violations stayed at $964 per infraction but the maximum
fine has been raised to $13, 653 for both Serious & Other Than
Serious Violations:
https://www.osha.gov/memos/2021-01-11/2021-annual-adjustments-osha-civil-penalties
In 2020, the minimum penalty for a Serious Violation is $964 per infraction and a maximum of $13, 494. For an Other-than-Serious violation (usually administrative violations), the minimum can be as little as zero dollars and as much as $13,494 per infraction. Read the entire document here: https://www.osha.gov/sites/default/files/2020-01/20200110124448588.pdf
Chemotherapy & Dangerous Drugs
Exposure to Hazardous Drugs is an issue of concern and alot of attention to the provisions of USP Standard 800 has been in the professional news lately. It has been our position that USP 800 DOES NOT APPLY to the use of commercially prepared chemotherapy drugs in a veterinary hospital. Our position is that OSHA's General Industry Standard is the governing authority for such activities. On November 25, 2019, the USP issued an updated FAQ on the provisions of USP 800.
In that updated FAQ, section 2 clearly states, "USP <800> only applies to handling of hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment. USP <795> and <797> were intended to contain reference to <800>, which would make <800> apply to compounding. For HDs, this means only when a practitioner is “compounding” (as that term is defined in <795> and <797>) would <800> be applicable. For example, since administration and dispensing final dosage forms is out of scope of <795> and <797>, <800> would not apply in this context.
You can read that FAQ here:
https://go.usp.org/General-Chapter-800-FAQ
Eye Injuries from canine otic medications
The U.S. Food and Drug Administration is alerting pet owners and
veterinary professionals about reports of eye injury and irritation
in both people and dogs following application of the canine ear
medications Osurnia® or Claro® to dogs.
https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm587781.htm
As of July 1, 2017, Gabapentin is now a
schedule V controlled drug in Kentucky. Other states are
expected to follow.
Click here to read the press release
On July 2, 2014, the DEA issued the final notice making Tramadol a schedule IV FEDERAL controlled drug effective August 18, 2014. Veterinary practices must now inventory, secure and record all uses of Tramadol. Read the notice here: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0702.htm
On August 22, 2014, the DEA issued the final notice changing all hydrocodone products from a Schedule III to a Schedule II classification. This will result in more restrictive ordering and prescribing rules. The effective date of this new rule is October 6, 2014. Read the notice here: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0822.htm
Did You Know...
Controlled substance regulations do vary slightly state by state, but they can never be less stringent than the federal rules.
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.
