CERSI P.I.s and Collaborators:Ashlee Mattingly, Ph.D., Steven Hoag, Ph.D., James Polli, Ph.D.
FDA SMEs and Collaborators: Charles Ganley, M.D., Gabrielle Cosell, MSc, Sara Rothmen, MPH, Rosilend Lawson, Elizabeth Hanklen



In 2012, the New England Compounding Center meningitis outbreak killed over 60 people, due to contaminated steroid injections, which were typically being administered in an office or clinic setting to treat back and joint pain.  Although the New England Compounding Center was registered as a pharmacy, it was acting as a manufacturer by compounding medications on a much larger scale not pursuant to a prescription.

As a direct result, the Drug Quality and Security Act was passed.  This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created Section 503B.  This section creates a new category of compounders, outsourcing facilities, and grants the FDA the authority to regulate facilities that voluntarily register as such.  An outsourcing facility is a facility that is engaged in the compounding of sterile drugs.  They do not have to be licensed pharmacies, but compounding must be by or under the direct supervision of a licensed pharmacist, nor do they have to receive a prescription prior to compounding.  Drugs compounded by outsourcing facilities, similar to compounding pharmacies, are eligible for exemptions from new drug approval requirements, labeling with adequate directions for use, and the supply chain security requirements.  However, one key distinction is the requirement that outsourcing facilities adhere to current Good Manufacturing Practices.  Outsourcing facilities are also required to report to the FDA all of the products compounded at the facility within the previous 6 months. 

In an effort to ensure the safety and quality of the materials used in compounding at outsourcing facilities, bulk drug substances can only be used if they appear on a list of drugs approved by the FDA as demonstrating a clinical need.

Current status of list of bulk drug substances 
Several bulk drug substances were nominated by prescribers, patient advocates, and chemical companies.  Examples vary from acetylcysteine to zinc sulfate.  A list of nominated bulk drug substances can be found online.  This nomination list is composed of about 200 substances.  The next phase is for the FDA to evaluate each substance nominated to determine whether it should be included or excluded from this list. 
Project Overview 
The University of Maryland is helping the FDA identify what bulk drug substances are ordered as compounded medications for patients or for “office stock”.  In particular, we are interested in how bulk drug substances, after being compounded by outsourcing facilities, have been and/or are currently being used (e.g. drug and “indication” or type of patient, dose, dosage form, route of administration).

We do not want to miss any bulk drug substances that prescribers and their patients need, either taken by the patient at home or “office stock” for use in the clinic or office.  Missing bulk drug substances would cause difficulty in outsourcing facilities to make compounded drugs that have been ordered by prescribers. Since different type of prescribers may order the same drug, but for different types of patients, different doses, or different routes of administration, we wish to know how even the same drug is used in different medical conditions.

Learn more on the U.S. Food and Drug Administration website.