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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Do compounded medications expire more quickly? WARNING TO PATIENTS
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<blockquote data-quote="Nelson Vergel" data-source="post: 225826" data-attributes="member: 3"><p>USP’s proposed changes to <em>sterile</em> compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add “likely cost-prohibitive” to that list: Stability studies have a price tag of around $30,000, Davis said.</p><p></p><p>The proposals would also limit batch sizes across the board to 250 units – a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times.</p><p></p><p>USP’s proposals would also impose arbitrary upper BUD limits as low as 60 days — even if existing, rigorous stability data justify a longer BUD.</p><p></p><p>“At the end of the day, these proposals won’t do anything for patients except require them to refill more frequently and increase the costs of those refills,” said Grzib.</p><p></p><p><strong>For more detail, on the USP proposals, <a href="https://a4pc.org/files/2022-01-20_Presentation-Proposed-USP-Updates-for-Providers.pdf" target="_blank">you can read the slides presented at the town hall here</a> (PDF)</strong></p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 225826, member: 3"] USP’s proposed changes to [I]sterile[/I] compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add “likely cost-prohibitive” to that list: Stability studies have a price tag of around $30,000, Davis said. The proposals would also limit batch sizes across the board to 250 units – a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times. USP’s proposals would also impose arbitrary upper BUD limits as low as 60 days — even if existing, rigorous stability data justify a longer BUD. “At the end of the day, these proposals won’t do anything for patients except require them to refill more frequently and increase the costs of those refills,” said Grzib. [B]For more detail, on the USP proposals, [URL='https://a4pc.org/files/2022-01-20_Presentation-Proposed-USP-Updates-for-Providers.pdf']you can read the slides presented at the town hall here[/URL] (PDF)[/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Do compounded medications expire more quickly? WARNING TO PATIENTS
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