In a recent update, the U.S. Food and Drug Administration (FDA) has introduced key tools to streamline the process of cosmetic product facility registration and listing, aligning with the mandates of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
- SPL Xforms: The FDA has released a new tool, SPL Xforms, for electronically submitting cosmetic product facility registrations and product listings. While electronic submission isn’t mandatory, it’s strongly encouraged.
- Paper Forms Available: Prefer the traditional route? No problem! Form FDA 5066 and 5067 offer a paper submission option.
- Register your facilities: Although an extension is granted, but all cosmetic manufacturers and processors were supposed to register their facilities with the FDA by December 29, 2023.
Your Action Plan:
- Review the Updated FDA Guidance: Familiarize yourself with the latest requirements and procedures.
- Choose Your Submission Method: Weigh the pros and cons of electronic tools like SPL Xforms versus paper forms.
- Seek Expert Support: Consider partnering with experienced consultants for a stress-free compliance journey.
Why Act Now?
- Avoid the rush: Leaving things to the last minute can lead to errors, delays, and potential FDA penalties.
- Gain a head start: Early compliance opens doors to valuable insights and potential adjustments before the deadline.
- Peace of mind: A proactive approach to MoCRA ensures your business operates seamlessly amidst the new regulations.
Register with FDA today
- Register your facility
- List your cosmetic products
- Designate a U.S. Agent for FDA communications
- Report serious adverse events
We understand the intricacies of MoCRA and its requirements, guiding you through every step of the registration and listing process. Contact us today at email@example.com to get FDA MoCRA compliant.
Quality Smart Solutions have served over 2000 brands for last two decades and have a distinct expertise to minimize your compliance risk in ever evolving regulatory landscape and ensuring your business operates smoothly and confidently.