{"id":3912,"date":"2022-03-18T10:37:56","date_gmt":"2022-03-18T14:37:56","guid":{"rendered":"https:\/\/a4pc.org\/?p=3912"},"modified":"2022-04-29T10:39:13","modified_gmt":"2022-04-29T14:39:13","slug":"cc-march-18-2022","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-03\/cc-march-18-2022\/","title":{"rendered":"CC: March 18, 2022"},"content":{"rendered":"
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\"Masthead\" <\/p>\n

The voice for pharmacy compounding | March 18, 2022<\/p>\n<\/div>\n

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\"Our<\/a><\/p>\n<\/div>\n

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\u27a4 From APC\u2019s President<\/h1>\n

SWOT, Part 5<\/h2>\n


\nDavid J. Miller, RPh
\nAPC President<\/p>\n

Last week, I addressed APC\u2019s opportunities \u2014 including membership, Tricare, FDA and technicians.<\/p>\n

The \u201cT\u201d in SWOT stands for threats<\/em>.<\/p>\n

APC and pharmacy compounding have always faced threats, small and large. FDA overreach is an ongoing fight and probably the greatest threat we face; the agency just seems to become ever emboldened in its efforts to marginalize our profession.<\/p>\n

Just last month, in a letter to members of Congress<\/a> who had written to the agency to urge caution in restricting compounded hormones, the agency stated:<\/p>\n

\u201cFDA believes the results of NASEM\u2019s research provide important information that will increase public understanding regarding cBHRT products. When developing agency policies, FDA intends to consider the information in the NASEM report,<\/strong> along with information and comments received from members of the public, while taking into account patient access concerns.\u201d<\/p><\/blockquote>\n

FDA sticking with that debunked report isn\u2019t a surprise \u2014 but now there are rumors that it could move to put hormones on the \u201cdemonstrably difficult to compound\u201d list as early as this summer. We all know that hormones are not<\/em> difficult to compound; three-quarters of APC members do it regularly, and they rely on compounded hormones as a clinical and business line. Without cBHT, many of us would cease to exist as compounders.<\/p>\n

(And don\u2019t forget that FDA also commissioned a NASEM report on compounded topical pain therapies. If it\u2019s successful with limiting cBHT, you can bet it will take similar action on those.)<\/p>\n

These threats doesn\u2019t apply only to humans. In its Guidance for Industry #256<\/a> the agency shows its intent to meddling in the practice of veterinary<\/em> medicine \u2014 prohibiting compounding for animals from pure ingredients in most circumstances.<\/p>\n

These are threats, but they\u2019re also opportunities. And that\u2019s why I\u2019ve stressed increasing our membership, strengthening CompPAC, and working with agencies like FDA. Please help.<\/p>\n