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FDA Peptide Mandate: FDA Announces Changes to Compounding of Peptide Supplements

FDA Peptide Mandate

In a recent development, the Food and Drug Administration (FDA) has introduced new regulations concerning the compounding of several peptide supplements, including Kisspeptin-10, AOD 9604, BPC-157, CJC-1295, and Ipamorelin, to name a few. These compounds, often sought after for their potential health benefits, are subject to updated guidelines aimed at ensuring safety and efficacy. The FDA Peptide Mandate is prompted by their decision to reclassify these peptides as Category 2 of the Bulk Drug Evaluation list. According to the FDA, pending further evaluation, drug products compounded using these peptides are not eligible for pharmacy compounding in the United States.

Thrive Health Solutions wants to be transparent and share that they do not support this move and are diligently working alongside industry partners to address this change. Thrive understands the profound impact these medications have had on patients with various ailments, especially those for whom traditional medications offer limited relief. Thrive’s belief remains firm that these compounds are highly beneficial and essential to patients, supported by available data and millions of patients that illustrate high efficacy and minimal safety risk.

In response to these regulatory changes, Thrive Health Solutions, a leading provider of peptide therapy in Colorado, has taken a proactive stance. Thrive has decided to temporarily halt all discounts on these peptides and will not receive any more inventory until further notice. However, Thrive understands that several of their clients have pending purchases, and some are on monthly regimens, so Thrive will continue to sell their existing inventory until it is depleted. Thrive is doing this to thoroughly evaluate and adapt to the new rules set forth by the FDA.

Thrive understands that this development may bring concerns and frustrations, and Thrive shares them wholeheartedly. Thrive is committed to not only addressing this issue through the appropriate channels but also empowering its community of pharmacies, providers, and patients to join in this endeavor.

Thrive needs your help! Your voice and insights are crucial to overturning this decision. Please express your concerns and frustrations directly to the FDA by submitting public comments here or by emailing compounding@fda.hhs.gov and druginfo@fda.hhs.gov. Please share this and urge them to send a message to the FDA. Together, our collective voices can emphasize the importance and safety of these peptides, fostering a reconsideration of this move.

Thrive sincerely apologizes for any inconvenience this may cause and assures you of our unwavering commitment to continue providing high-quality products and services that promote optimal health outcomes. Thrive Health Solutions remains committed to keeping its customers informed throughout this process. Updates on the status of these peptides and their availability will be provided as soon as they become available.

If you have any questions or require further information, please feel free to reach out to Thrive Health Solutions at info@thrivecolorado.com or by text at (303) 790-8446.

Thrive appreciates your understanding, support, and partnership as we navigate through this unfortunate development.

Best Regards,
Management at Thrive Health Solutions

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