Saturday, November 1, 2014

Proliferation of Rogue Online Drug Sellers Feeds Prescription Drug Abuse Epidemic, NABP Reports


 Topics: Counterfeit Drugs and Buying Medicine Online
The National Association of Boards of Pharmacy® (NABP®) today issued a report highlighting a connection between the proliferation of rogue online drug sellers and the prescription drug abuse epidemic.
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Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--FDA DocketID: FDA-2013-N-1525

view all 213 comments received:

here

IACP's comments Docket ID: FDA-2013-N-1525 Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations

 
  • Thank you for the opportunity to submit our comments on FDA’s request for a list of bulk drug substances that may be used in pharmacy compounding as defined within Section 503A of...
  • Public Submission
     
  • Posted:
     
    08/11/2014
     
  • ID:
     FDA-2013-N-1525-0107

Third Question of the Day November 1, 2014 Are there any compounding pharmacies that verify Certificates of Analyses (CoA) data with further testing? If so, is the testing for all parameters and results listed on the CoA's? If no verification is done and there is no warranty, isn't this problematic because of grey markets, counterfeit and substandard bulks that threaten the supply chain?

Second Question of the Day November 1, 2014 Does anyone know of any repackager that provides warranty for results stated on CoAs for API or Bulk Chemicals?


Bulk Compounds: Docket ID: FDA-2013-N-1525: There were over 200 comments--Check out PCCA's list and note the appended Certificates of Analyses (CoA's) have disclaimer of warranty; express or implied. Also note the disclaimer states that PCCA may be relying on a supplier's (broker/agent) data with further testing.

To Whom It May Concern: Please find attached PCCA's cover letter
 and spreadsheet of nominated items to the list of "Bulk Drug Substances 
That May Be Used To... View Comment
Posted: 10/31/2014
ID: FDA-2013-N-1525-0218

Updated List as of 10/24/2014 Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

Question of the Day November 1, 2014 Why would a supplier of API or bulk chemicals to be used in compounded preparations rely on what their supplier says the chemicals are? Why would they not test and provide a warranty that the chemicals are what they say the chemicals are?


Kudos to the New Mexico Board of Pharmacy for Adding Share Buttons so that their Agendas and Minutes are easily shared with others!!


Mexico Board of Pharmacy Minutes from August 2014 Meeting Discusses a Number of Rule Changes

http://www.rld.state.nm.us/boards/Pharmacy_Members_and_Meetings.aspx