14 Covetrus
|
ph:
855.724.3461
|
fx:
888.329.3861
|
northamerica.covetrus.com
References
1. Accreditation Commission for Health Care. Compounding pharmacy accreditation. ACHC website. https://www.achc.org/compounding-pharmacy. Accessed April 6, 2021.
5. United States Pharmacopeia. Compounded preparation monographs (CPMS). USP website. https://www.usp.org/compounding/compounded-preparation-monographs.
Accessed April 6, 2021.
6. United States Pharmacopeia. Approved USP compounded monographs. USP website. https://go.usp.org/l/323321/2020-04-30/36chsl/323321/106165/2019_02_approved_usp_
compounded_monographs.pdf. Accessed April 6, 2021.
7. United States Pharmacopeia. Compounded preparation monographs: failed studies. USP website. https://go.usp.org/l/323321/2020-04-30/36chwl/323321/106169/usp_
compounded_preparation_monographs_failed_studies.pdf. Updated April 9, 2020. Accessed April 6, 2021.
14. US Food & Drug Administration. January 31, 2018: New England Compounding Center pharmacist sentenced for role in nationwide fungal meningitis outbreak. US FDA website.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/january-31-2018-new-england-compounding-center-pharmacist-
sentenced-role-nationwide-fungal. Accessed April 6, 2021.
15. Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections. CDC website. https://www.cdc.gov/hai/outbreaks/meningitis.html.
Updated October 30, 2015. Accessed October 16, 2020.
16. US Food & Drug Administration. Compounding laws and policies. US FDA website. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies.
Accessed April 6, 2021.
17. US Food & Drug Administration. Information for outsourcing facilities. US FDA website. https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities.
Accessed April 6, 2021.
18. US Food & Drug Administration. Facts about the current good manufacturing practices (CGMPs). US FDA website. https://www.fda.gov/drugs/pharmaceutical-quality-
resources/facts-about-current-good-manufacturing-practices-cgmps. Updated June 25, 2018. Accessed October 16, 2020.
How is quality assurance enforced?
State boards of pharmacy (SBOP) are the primary
compounding quality enforcers. SBOP set quality standards
according to their state's pharmacy practice act, which may
or may not adopt USP standards. SBOP can inspect and
audit any licensed pharmacy without notice. Inspectors
will provide a list of any infractions and a time period to
make improvements; failure to do so can result in a revoked
pharmacy license and/or fines.
Conclusion
Quality assurance is critical in compounding. Staff, space,
equipment, ingredients, and procedures should be of the
highest caliber and routinely assessed. Teamwork and
communication between the veterinarian, the compounding
pharmacist, and the pet owner should be prioritized to
uphold patient safety.
In the Q4 Animal Health Solutions, we will have the
next and final article in this series exploring upcoming
regulatory and industry updates and changes.
About the author Jennifer Kobylarczyk, PharmD, FSVHP, is a clinical consultant pharmacist at and the owner of Avant
Pharm Care in Lakewood, Colorado, as well as a compounding pharmacist at Wise Pharmacy. She earned her PharmD from University
of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. She is also a clinical veterinary pharmacist with Plumb's
Veterinary Drugs and has received her veterinary pharmacotherapy certification and PCCA compounding certificate.
