Animal Drug Compounder Survey
The Animal Health Compounding Special Interest Group is conducting a survey to assess the impact of recent regulations on veterinary compounding practices and the buying behavior of veterinarians and animal caregivers. Your participation will help all of us gain insights into the current landscape and provide data for future advocacy efforts. About the Survey: This survey should take approximately 10 minutes to complete. All responses will be kept confidential. We will share the anonymized results with the Animal Health Compounding Special Interest Group members and the broader APC membership.
What percent of your compounding is for use by veterinarians or animal caregivers?
*
Please Select
0-20%
21-40%
41-60%
61-80%
81-100%
How familiar are you with the FDA's Guidance for Industry #256 (GFI #256) on Compounding Animal Drugs from Bulk Drug Substances?
*
Not at all familiar
Somewhat familiar
Expert
For what areas of GFI #256 compliance do you need more education
*
The under review, listed, and not listed lists
How to nominate drugs for the lists
What is considered essentially of copy of a commercially available medication
Rationale for using bulk drug substances
Capturing clinical rationale
Reporting adverse events on Form 1932a
Herd and litter prescribing
Prescribing for free ranging wildlife and food chain animals
What challenges are you facing with GFI #256 compliance?
How have the changes introduced by GFI #256 impacted your veterinary compounding practice? (select all that apply)
*
Increased costs
Reduced product offerings (discontinued items)
Reduced demand
Increased demand
No significant impact
Improved regulatory clarity
Business differentiation opportunities for marketing purposes
Other
If other, please specify
What feedback are you getting from veterinarians regarding implementation of GFI #256?
Are you familiar with the recent changes to the United States Pharmacopeia (USP) chapters <795> and <797> for compounded medications?
*
Yes
No
Does your state board of pharmacy require compliance with the latest USP chapters for compounded medications?
*
Yes
No
Unsure
For what areas of the new USP (<795>, <797>, and <800>) do you need more education for compliance?
*
USP <795>
USP <797>
USP <800>
All
None
What challenges are you facing with complying with the new USP Chapters?
What actions have you taken to be compliant with USP? (select all that apply)
*
Shortened BUDs
Conducted stability studies to provide longer BUDs
Changed formulas to be non-aqueous
Reduced product offerings
Increased BUDs on aqueous preserved products to 35 days
Became a member of a vendor that offers stability studies
Partnered with another pharmacy to perform stability studies
Stopped compounding sterile medications
I have not taken any actions to be compliant with USP
Other
If other, please specify
If "reduced product offerings" and/or "stopped compounding sterile medications was selected, approximately what percentage of your compounded offerings have been discontinued?
None
5-20%
21-40%
41-60%
61-80%
81-100%
How have the new USP requirements impacted your compounding costs?
In your experience, how has the prescribing behavior of veterinarians changed since the implementation of GFI #256 and the new USP chapters?
Looking ahead, do you anticipate increasing or decreasing your investment in providing veterinary compounding services for your prescribers and animal caregivers?
*
Increase
Decrease
Remain Stable
Briefly explain your reasoning.
It is possible that at some point, the industry would consider litigation challenging FDA's authority to regulate compounding for animals, including issuance of GFI #256. How interested would you be in this type of litigation?
*
Not at all interested
I'd like to see litigation, but I would not participate
I think the industry should strongly consider litigation and I would participate
Any parting thoughts?
Please leave your email address if you would like us to contact you regarding any questions.
Name:
E-mail Address
Thank you for completing our survey.
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