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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Your Access to More Economical hCG and FSH Ended in November 2021
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<blockquote data-quote="xqfq" data-source="post: 163848" data-attributes="member: 38167"><p>Damn, I was having such a nice day so far!!</p><p></p><p>I'm trying to figure out what's going on here. According to <a href="https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval" target="_blank">Biosimilar Development, Review, and Approval</a>, it sounds like there's a relatively new (2009?) pathway for 'biologic' products to be FDA approved.</p><p></p><p>What's potentially changing here? Was this 2009 law passed and it's just now going into effect or something?</p><p></p><p>So is the problem that, if HCG, FSH, etc is added to this list, that compounding pharmacies would have to get their "drug" approved via the "streamlined" approval process? Meaning a lot more up front investment to produce their products?</p><p></p><p>----</p><p></p><p>Edit: After reading a bit more, it sounds like the 2009 law was designed to..get this..lower prices of these 'biologic' drugs! But this is going to do the exact opposite, at least for those of us getting inexpensive HCG, FSH, etc from compounding pharmacies!</p><p></p><p>I wonder how much of this is truly just the FDA's interpretation of the law. It sounds like there may be a conflict between the law that governs the compounding pharmacies' ability to produce drugs without getting 'pre-approval' (or whatever it is, the process) and the 2009 biologic law. The 2009 biologic law could be interpreted to mean that 'pre-approval' (or whatever it is, the process) MUST be obtained even for compounding pharmacies.</p><p></p><p>I skimmed Section 351(a)(1) of the PHS Act and it seems like there could be an alternative interpretation. There has to be, otherwise wouldn't these compounding pharmacies have seen the writing on the wall since 2009?</p><p></p><p>So maybe this is the FDA basically interpreting this law in this particular way, which is coincidentally the way the big pharma companies would like it to be..</p></blockquote><p></p>
[QUOTE="xqfq, post: 163848, member: 38167"] Damn, I was having such a nice day so far!! I'm trying to figure out what's going on here. According to [URL='https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval']Biosimilar Development, Review, and Approval[/URL], it sounds like there's a relatively new (2009?) pathway for 'biologic' products to be FDA approved. What's potentially changing here? Was this 2009 law passed and it's just now going into effect or something? So is the problem that, if HCG, FSH, etc is added to this list, that compounding pharmacies would have to get their "drug" approved via the "streamlined" approval process? Meaning a lot more up front investment to produce their products? ---- Edit: After reading a bit more, it sounds like the 2009 law was designed to..get this..lower prices of these 'biologic' drugs! But this is going to do the exact opposite, at least for those of us getting inexpensive HCG, FSH, etc from compounding pharmacies! I wonder how much of this is truly just the FDA's interpretation of the law. It sounds like there may be a conflict between the law that governs the compounding pharmacies' ability to produce drugs without getting 'pre-approval' (or whatever it is, the process) and the 2009 biologic law. The 2009 biologic law could be interpreted to mean that 'pre-approval' (or whatever it is, the process) MUST be obtained even for compounding pharmacies. I skimmed Section 351(a)(1) of the PHS Act and it seems like there could be an alternative interpretation. There has to be, otherwise wouldn't these compounding pharmacies have seen the writing on the wall since 2009? So maybe this is the FDA basically interpreting this law in this particular way, which is coincidentally the way the big pharma companies would like it to be.. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Your Access to More Economical hCG and FSH Ended in November 2021
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