Fairly regularly, we get asked why HCG and peptides can\u2019t be compounded and why APC can\u2019t do something about it. Here\u2019s the skinny:<\/p>\n
HCG was swept up in legislation passed by Congress a dozen years ago (but which did not take effect until March 2020) that reclassified a number of substances as biologics, which put them outside the reach of most 503A compounders. Despite our efforts, FDA has shown no interest in exercising enforcement discretion in allowing HCG to continue to be compounded. Over the past 24 months we\u2019ve put out at least two calls for our members to help us collect data demonstrating patient harm \u2014 demonstrating that patients have not been able to access essential therapies \u2014 that has resulted from the reclassification, but the fact is, we\u2019ve not received any such data. We do believe that kind of data would be useful in making a case to FDA.<\/p>\n
\u201cWhy not just change the law?\u201d you\u2019re probably thinking. Easy answer: Big Pharma and its regiment of lobbyists. It\u2019s frankly not a Capitol Hill fight we think we can win, and to have to give our limited bandwidth to such a fight will take our attention away from other important and more winnable battles.<\/p>\n
Peptides<\/em> are a bit different. Peptides<\/em> are not restricted per se. The reason you generally can\u2019t compound them (and there are exceptions, like semaglutide and sermorelin) is because they DO NOT MEET FDA\u2019S CRITERIA: They don\u2019t have a USP or NF monograph, they\u2019re not part of an FDA-approved drug product, and they\u2019re not on the Category 1 or \u201cpositive\u201d lists.<\/p>\n And that\u2019s the explanation you should give to prescribers who push you to compound them.<\/p>\n","protected":false},"excerpt":{"rendered":"