The International Academy of Compounding Pharmacists (IACP) is the first pharmacy association to submit comments to the FDA on its Request for Bulk Drug Substances for both Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.

IACP is ensuring that the voice of our pharmacy compounding members is heard! We urge our members to use our language or positions in submitting your own bulk drug lists to the FDA, which are due by March 4, 2014. 

“IACP is committed to working closely with the FDA and Congress to assure that the Drug Quality and Security Act is implemented swiftly so that no patient or physician experiences any disruption in medication treatment,” said IACP President Pat Stephens, PharmD.  “Thanks to the efforts of our members and the leadership of the IACP Foundation, we were able to identify and present our comments on the request for APIs that traditional compounders need access to in order to assure patient care.”

There are four submission letters for each type of compounder – a pharmacy or an outsourcing facility. One is a nomination letter that submits all homeopathic medications. One is a nomination letter requesting acceptance of drug monographs and standards in alternative compendia (e.g., the British Pharmacopeia). One is a nomination letter requesting acceptance of all nutritional/dietary supplements and food chemicals that appear in USP publications other than the official USP/NF. One is a nomination letter and spreadsheet of more than 2,400 drug substances. That spreadsheet was created by the IACP Foundation leadership and without the Foundation’s expertise in research, education and quality, we could not have assembled such an extensive set of documentation in the very short timeline provided to us by the FDA.

What can YOU do? 

The more submissions the FDA and the Pharmacy Compounding Advisory Committee receives, the greater the likelihood that they will initiate a review of the nominated bulk ingredient. It’s simple.  We’ve done the hard work…all you have to do is take the language in our submissions, put it on your own letterhead, and follow the instructions further down on how to file your own nomination electronically with the FDA.

Remember, the deadline is before midnight on Tuesday, March 4, 2014.

PLEASE NOTE: You must be an IACP Member to access this material. Please click here to log into the IACP Member Center to view the documents below.

IACP Comments to FDA Regarding 503A for Your Review

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding for 503A – En Bloc Submission of The Homeopathic Pharmacopeia of the United States.

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A – En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP).

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A – En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC).

IACP’s Nominations on Bulk Ingredients 503A.

IACP Nominations on Bulk Ingredients 503A Non USP Non Approved Drug Substances – List.


IACP Comments to FDA Regarding 503B for Your Review

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The Homeopathic Pharmacopeia of the United States.

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP).

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC).

IACP’s Nominations on Bulk Ingredients 503B.

IACP Nominations on Bulk Ingredients 503B Non USP Non Approved Drug Substances – List.


Instructions for Submitting Your Own Bulk Drug Comments to FDA

IACP’s Comparison Chart of 503A and 503B – The Drug Quality and Security Act of 2013.

Instructions on how to Submit your Own Bulk Drug List to FDA – Due by March 4, 2014.

 

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 3,600 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding.  Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. Visit www.iacprx.org to learn more.

Please email iacpinfo@iacprx.org with any questions regarding this information.

 

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