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Breaking Regulatory News

New!! OSHA has updated the Civil Penalties for violations.  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

NEW!!  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://www.usp.org/sites/default/files/usp/document/our-work/compounding/faqs-usp-800.pdf


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.


The Complete Veterinary Practice Regulatory Compliance Manual