FDA issues new draft documents related to compounding of human drugs

Updated November 24, 2020

Links broke in the original post.

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Human Drug Compounding - FDA.gov

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Read the full press release, and find links to the guidances:
Press Announcements > FDA issues new draft documents related to compounding of human drugs - FDA.gov:

"Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states"

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14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com

Read the full article: 14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com:

"The arrests signal the beginning of criminal proceedings against the New England Compounding Center, whose contaminated drugs led to the deaths from fungal meningitis of 64 people in the fall of 2012. More than 680 people were sickened.

The contamination caused an uproar and prompted new legislation about compounding pharmacies, which make specialized formulations of drugs for patients with particular needs. Over the years, such companies have grown into mass manufacturers distributing medicine all over the country, virtually unregulated by the federal government."

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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute