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News & Press: ACAM Action Alerts

Compounded Medications are at Risk

Monday, October 21, 2019  
Posted by: Administrator
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Hello,

 

Thousands of patients are at risk of losing access to life-saving compounded medications, and we need your help.

 

Despite a long history of safe use and patient need,the FDA is in the process of reviewing and potentially blocking patient accessto more than 300 ingredientsused in compounded medications.The FDA’s current position is that if there is an approved pharmaceutical equivalent that will address the condition, the compounded ingredient is not needed.

 

By dismissing why patients need personalized medicine, the FDA is discounting functional medicine uses and only taking into consideration whether an ingredient addresses a specific disease.

 

In September, the FDA published a draft rule that - if finalized as currently written - would make 26 ingredients illegal to compound.

 

Ingredients Impacted

 

7-keto dehydroepiandrosterone (DHEA)

Acetyl-L-Carnitine

Alanyl-L-Glutamine

Aloe Vera 200:1 Freeze Dried

Artemisinin

Astragalus extract 10:1

Boswellia

Cesium Chloride

ChondroitinSulfate

Chrysin

Curcumin

D-Ribose

Deoxy-D-Glucose

Diindolylmethane

Domperidone

Epigallocatechingallate(EGCG)

Germanium Sesquioxide

Glycyrrhizin

Kojicacid

Nettle

Nicotinamideadenine dinucleotide(NAD)

Nicotinamideadenine dinucleotidedisodiumreduced (NADH)

Rubidium Chloride

SodiumDichloroacetate

VanadylSulfate

Vasoactiveintestinal peptide

 

Use your voice to submit a comment to the proposed rule. Please note, we are only looking for comments on the 26 ingredients. Comments that mention other ingredients will be ignored by the FDA. The last day to submit a comment is December 4.

 

Thank you for fighting to protect patient access to compounded medications.

 

 

To learn more, click here.


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