IACP SEEKS FDA APPROVAL OF BULK DRUG SUBSTANCES

LIST FOR COMPOUNDING PHARMACISTS

WASHINGTON, D.C. (March 5, 2014) – The International Academy of Compounding

Pharmacists has responded to a request for submissions from the U.S. Food and Drug

Administration (FDA) under the recently enacted Drug Quality and Security Act for Active

Pharmaceutical Ingredients (APIs) commonly used by compounding pharmacists to ensure the

appropriate treatment of patients.

These APIs, commonly called bulk ingredients, are the raw chemical components used in

prescription drugs by manufacturers to produce finished drug products and by compounders to

prepare customized patient therapies. Unlike the finished drug products themselves, bulk

ingredients are not FDA approved. The IACP, responding to the FDA’s request for interested

parties to nominate substances, has submitted a list of more than 2,400 bulk drug substances

which are regularly used by compounding pharmacists but which have neither an official United

States Pharmacopeia (USP) monograph nor appear to be a component of an FDA-approved drug

product.

“The compounding community is working diligently to ensure that the FDA has all the

information the agency needs to move forward with the implementation of the Drug Quality and

Security Act,” said Pat Stephens, Pharm.D., President of the IACP. “We identified our list of

bulk drug substances through a poll of our membership, as well as a review of the latest scientific

and medical literature related to compounding pharmacy. Additionally, we are indebted to the

IACP Foundation for its tireless work in helping identify as much information about each bulk

ingredient as possible through the medical and scientific literature.”

The IACP also submitted for approval the drugs and standards contained within the following

official compendia recognized by the FDA but which were not explicitly included in the Drug

Quality and Security Act:

The Homeopathic Pharmacopeia of the United States, because compounding pharmacists

are frequently asked to prepare homeopathic medications;

 The British Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia,

because compounding pharmacy practice dictates that alternative compendia such as

these may be used to assure quality compounding preparation; and

 The Food Chemicals Codex and the USP Dietary Supplements Compendium, because

compounding pharmacists often prepare medications that contain dietary supplements or

food chemicals, especially dyes and additives for patients who are unable to obtain drug

dosage forms or strengths in commercially manufactured drugs.

The IACP has requested that the FDA’s Pharmacy Compounding Advisory Committee accept

and approve all of the bulk drug substances in these compendia as acceptable APIs for the

preparation of compounded medications under Section 503A and 503B of the Drug Quality and

Security Act, the recently enacted revisions to the Federal Food, Drug, and Cosmetic Act.

Section 503B covers compounding pharmacies which are designated by the FDA as “outsourcing

facilities” specializing in large-scale production of sterile medications.

The IACP also nominated for 503B outsourcing facilities all drug substances which appear in the

current edition of the United States Pharmacopeia/National Formulary. As written, the Drug

Quality and Security Act requires those life-sustaining medications to also undergo a review and

approval process before an outsourcing facility may use them in their compounding of sterile

preparations.

“We respectfully request that the Committee review each of the 2,403 drug substances we have

submitted for traditional compounding pharmacies and for 503B outsourcing facilities,” said

David G. Miller, R.Ph., the IACP’s Executive Vice President and Chief Executive Officer. “Our

Academy looks forward to working with the FDA on this important aspect of the law’s

implementation and we hope that the Pharmacy Compounding Advisory Committee works

quickly to assure that there are no disruptions in the access to and use of these critical substances

in the preparation of medicines that patients need each and every day.”

The IACP’s requests to the FDA may be found online by clicking here.

quoted from here