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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: 225825" data-attributes="member: 3"><p>Unfortunately, the FDA has limited compounding pharmacies to shorter BUDs, even when they are able to do the same time-point stability studies that commercial pharmaceutical companies utilize. The maximum BUD under USP conditions is 1 year, however due to the high cost of doing stability studies most compounders strive for 3-6 months. In addition, many products that compounding pharmacies produce for HRT/Integrative health contain ingredients that do not remain stable for a long time. This includes many of the injectable nutrients, peptide hormones, etc. When a compounding pharmacy produces a batch that has been established with a 6 month BUD that doesn't mean there will be 6 months left of usage by the time the patient receives it, most compounders try to dispense everything with a min of 3 month remaining which usually accommodates most uses.</p><p></p><p>This might also be a good place to plug the current “BUD issue” where the FDA wants to limit compounders to 90 days BUD max. This will essentially put compounders out of business. Since there is zero scientific basis for this proposal everyone suspects it’s a “hail mary” to hinder compounding. There is a great white paper submitted by APC proving the FDA has no scientific reason for this. I believe there is a commenting period for providers/patients.</p><p></p><p>[MEDIA=vimeo]668435158[/MEDIA]</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 225825, member: 3"] Unfortunately, the FDA has limited compounding pharmacies to shorter BUDs, even when they are able to do the same time-point stability studies that commercial pharmaceutical companies utilize. The maximum BUD under USP conditions is 1 year, however due to the high cost of doing stability studies most compounders strive for 3-6 months. In addition, many products that compounding pharmacies produce for HRT/Integrative health contain ingredients that do not remain stable for a long time. This includes many of the injectable nutrients, peptide hormones, etc. When a compounding pharmacy produces a batch that has been established with a 6 month BUD that doesn't mean there will be 6 months left of usage by the time the patient receives it, most compounders try to dispense everything with a min of 3 month remaining which usually accommodates most uses. This might also be a good place to plug the current “BUD issue” where the FDA wants to limit compounders to 90 days BUD max. This will essentially put compounders out of business. Since there is zero scientific basis for this proposal everyone suspects it’s a “hail mary” to hinder compounding. There is a great white paper submitted by APC proving the FDA has no scientific reason for this. I believe there is a commenting period for providers/patients. [MEDIA=vimeo]668435158[/MEDIA] [/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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