FDA Denies Petition to Allow Compounding Pharmacies to Make Testosterone Pellets

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Jinzang

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Testosterone pellets have been placed on the "difficult to compound" list, preventing compounding pharmacies from manufacturing them. A petition to reconsider this decision was denied. If I read the decision correctly, it was because proper procedure for contesting the decision was not followed. The decision is available as a pdf online.
 
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Misleading. This does not mean that the FDA said no. It means that compounders should include pellets in the petition process that is happening now. Here is the letter:
 

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  • FDA-2015-P-4601-0005 fda pellet.pdf
    2.1 MB · Views: 215
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