Welcome to the FLAVORx Regulatory Hub
Know the Rules in Your State So You Can Flavor Medications with Confidence.
Pharmacists and pharmacy technicians, we created this site to help you understand the rules around medication flavoring to ensure your policies and procedures follow your State Board of Pharmacy regulations or guidance. Importantly, the information contained here reflects most State Board of Pharmacy rules or guidance passed after the November 2022 publication of new USP 795 non-sterile compounding standards.
If you have any questions, please don’t hesitate to contact us by sending an email to regulatory@flavorx.com
Click the map below to see how medication flavoring is treated in your state.
Map Legend
Flavoring not subject to USP 795 guidelines per BOP rule, guidance, enforcement discretion, or legislative statute. Click on your state to learn more.
Flavoring subject to USP 795 guidelines per BOP rule or inspection action.
Please Note: Massachusetts, Minnesota, North Carolina, South Dakota, and Virginia have fully adopted USP 795 and thus do consider flavoring to be compounding. However, either through formal guidance or the use of enforcement discretion, these states do not subject the practice of flavoring to the full scope of USP 795 requirements. They are generally most often concerned about documentation of flavors being added to medications for record-keeping purposes.
Documentation required in the following states:
WA, CA, NV, AZ, CO, NM, TX, KS, SD, MN, IA, MO, WI, NC, SC, MA, VT
State Board of Pharmacy Requirements to Flavor Medications
FAQs
USP establishes guidelines to follow for non-sterile compounding. It’s up to each state to determine whether those guidelines will be enacted or enforced. A few states require compliance with USP standards when flavoring, but most don’t. The consensus amongst State Boards of Pharmacy is that USP 795 standards are excessive when it comes to medication flavoring.
Simple. Ask your flavoring supplier for tests showing their flavors do not impact the stability of medications. FLAVORx regularly tests our flavors when added to medications to ensure they are inert. We are happy to share copies of these test with you if you need them. If you work at a chain pharmacy, your corporate office usually has them on file.
If your State Board of Pharmacy requires you to document each time you flavor, they will typically ask you to record the date, time, initials of the person flavoring the medications, drug name, and flavors added. Sometimes you’ll be asked to document lot numbers and expiry dates of the flavors. We’re happy to help you navigate documentation requirements specific to your state.
Have questions about your state’s rules or need help interpreting a regulation? We can help!
Email: regulatory@flavorx.com
Phone: 800-884-5771