FDA Releases Guidance Directed at 503B Outsourcing Facilities
IACP Comments on the FDA's Press Release and Guidance Document Regarding "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act"
The  International Academy of Compounding Pharmacists (IACP) on behalf  of our more than 4,000 compounding pharmacists and the patients and providers they serve, is reviewing the statement and guidance document released by FDA regarding the FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities.  Upon our initial reading, there are strong concerns with this guidance and how it will impact patient access to compounded medications.  See  IACP's detailed response to FDA's statement and guidance below.  An excerpt of the FDA statement along with the link to full press release and link to the guidance document are listed below. 

IACP's Initial Comments Regarding the FDA Press Release, Guidance document and additional FDA comments

IACP's general impression is that the FDA's draft guidance, "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act", is a disincentive for anybody to register as a 503B, which makes it contrary to Commissioner Gottlieb's statements before the House E&C committee. As mentioned in the current guidance document lines 47-53, 

"Drug products compounded under the conditions in section 503B are not exempt from current good manufacturing practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act.5  Outsourcing facilities are also subject to FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that help to mitigate the risks of the drug products they compound.6 Outsourcing facilities may or may not obtain prescriptions for identified individual patients and can, therefore, distribute compounded drugs to healthcare practitioners for "office stock," to hold in their offices in advance of patient need. 7"
 
Within this framework, it is difficult to follow FDA's concerns about sources of pure ingredients (what FDA refers to as "bulk").  503B Outsourcing Facilities are required to purchase all ingredients according to statutory requirements, including that the pure ingredient manufacturers are FDA-registered and comply with all applicable quality standards.  Since FDA inspects the pure ingredient manufacturers and the outsourcing facilities to hold them accountable to those standards, the statements in this draft guidance that question the quality of the pure ingredients used by outsourcing facilities vs. those in FDA-approved drugs are false and misleading.
 
Further, the current draft guidance contains statements about the technical capabilities for a 503B outsourcing facility to accurately and safely prepare medications when using pure ingredients. These technical functions are exactly what compounding is, and that is why federal law requires outsourcing facilities to have a pharmacist in charge. FDA provides no evidence of enhanced accuracy or content uniformity when manipulating a manufactured product compared to producing the correct strength & dosage form at the outset using pure ingredients.  Further, the FDA's guidance for 503B Good Manufacturing Practice (issued July 2014) addresses these concerns, and if a registered entity is not compliant with the quality standards FDA has previously set out the Agency will no doubt cite them for it, as they do with all manufacturers and pharmacies they inspect.
 
The idea that a manufacturer should only be allowed to create finished products using a different manufacturer's version of the same finished goods is illogical and does not exist in any other industry that we are aware of, especially considering that both manufacturers operate under oversight of the same federal agency and deliver products to many of the same clients. Because of allowable variances in potency, starting a custom preparation from a finished FDA-approved product means the compounder does not know the actual potency of the starting materials.  Further, recalls on FDA-approved products are regular occurrences.  If those products are the sole source of starting materials for many outsourcing facility products, the risk of patient harm is significantly magnified.  There are outsourcing facilities today who only use FDA-approved products as their starting materials, such as PharmMEDium, yet FDA still finds significant quality-related issues during inspections. Looking at the full picture, it is clear that there is not evidence of enhanced safety or quality simply by requiring the use of finished drug products as the source of ingredients.
 
In addition, IACP has significant concerns regarding the "clinical need" definitions proposed in this draft guidance.  Determination of clinical need is made by the treating physician, yet FDA outlines several parameters they will use to determine clinical need for a manufactured drug that will be sold across the country.  FDA is inserting itself into the physician-pharmacist-patient triad relationship to dictate what they will consider a clinical necessity...but only if a pure ingredient is used.  If using an FDA-approved product, they apparently have no concerns over clinical necessity. 

Overall, this guidance does not prioritize the best interests of patients. To the contrary, this guidance prioritizes the market share of pharmaceutical manufacturers.
 
IACP would appreciate the opportunity to work with FDA on rules that truly consider what is best for the patient and preserves patient access to vital compounded medications.
FDA's Statement and Guidance Document Directed at 
503B Outsourcing Facilities


To read the guidance document "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act." Click  here .  

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities

For Immediate Release
March 23, 2018
Statement
Today, we're taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need - the 503B bulks list.
Today, we're issuing a critical policy document that addresses how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound drugs.
Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs. However, because compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness and quality; they also present a greater risk to patients than FDA-approved drugs. This was illustrated by the 2012 nationwide fungal meningitis outbreak. This tragic outbreak led to more than 750 cases of illness and the deaths of 64 individuals who had used a compounded drug for injection that was supposed to be sterile, but became contaminated.
In response to that public health tragedy, Congress enacted the DQSA in 2013 to enhance the safety and quality of these medicines. Advancing the FDA's compounding program is a high priority for the agency. We're fully committed to implementing the DQSA requirements in a way that preserves access to compounded drugs for patients who have a medical need for them, while protecting patients from poor quality or otherwise unsafe compounded drugs that could cause them serious harm.
The draft guidance we're releasing today is one part of a comprehensive policy framework. In January, we released our  compounding policy priorities plan, which lays out how the agency will implement, over the course of 2018, certain key provisions of DQSA and other requirements of the law relevant to compounders. The plan is comprised of a series of draft and final guidance documents, proposed and final rules, and a revised draft memorandum of understanding (MOU) between the FDA and states.  To read more click  here. 
IACP Members - This is not the time to sit on the sidelines!
Join us for CCH and walk the Halls of Congress

Registration for  Compounders on Capitol Hill  is 
NOW OPEN!

As a former Congressional staffer in the U.S. Senate and U.S. House of Representatives, I am often asked why storming the Hill during  Compounders on Capitol Hill (CCH) is so important and whether it's worth your time away from patients and your pharmacy. My answer is a resounding YES and here's why.
 
I've been on the other side of the table from you with the Senator and Congressman for many years during fly-ins on the Hill. Every other day, we met with lobbyists and attorneys and not to say that isn't important - but  no one can represent YOUR voice and the voices of your patients like YOU.  If you aren't showing up, you are gambling that someone else will represent your voice, your passion for preserving your industry and patient access, and share your personal stories - and that's a dangerous gamble to make. We have an incredible government affairs team at IACP that we are grateful for, but as they would also admit as former Congressional staffers - no voice is as powerful as YOUR voice. Compounding is personal and so are your stories and the stories of your patients.
 
Your Voice Matters - Your Vote Matters: The most common misconception I saw as a Congressional staffer was that pharmacists didn't understand how powerful their voice was and what makes them different from their opposition.  YOU have something that no one else has - YOUR vote which spans in every Congressional district.  You are a constituent; your patients are constituents and the providers you work with are constituents - and, constituents vote during elections, they tell those they work with, their families, and their friends how to vote as well. In times like these when our opposition is actively working against us on a daily basis - it's important to keep in mind that none of our opposition has this benefit that you have - but  you have to make that benefit count.  It's what makes you different and it's what makes 
YOUR presence as we Storm the Hill and walk the Halls of Congress at CCH so important.
 
If you are new to Hill day or feel that you want to ensure someone that is a Hill veteran goes to the Hill with you, don't let this hold you back!  We have added an option on the registration form where you can let us know! We have a vast army of volunteers from former Congressional staff, Corporate Members, and other Hill day veterans lined up ready to storm the hill with you!
 
We are also going to shake it up this year with some  incredible competitions coming your way for those who get the most folks to CCH!  We have some amazing prizes and awards in store! Stay tuned next week for the launch of these competitions and more information! No one's voice is more powerful than your voice on Capitol Hill and in getting your colleagues to join us at CCH!
 
Also, please note that in order to ensure you are able to attend all your scheduled meetings, please do not schedule your flight before 6 p.m. on Tuesday, June 26th!

So, tell your colleagues and tell your friends to  j oin us in Washington, D.C. for the 24th Annual  Compounders on Capitol Hill  (CCH), June 23-26, 2018 at the Renaissance Washington D.C. Downtown Hotel.

The stakes are too high, and this is not the time to sit on the sidelines and hope that someone else will represent your voice. 

Join your colleagues in preserving patient access and join us in the Halls of Congress to deliver this messaging like ONLY YOU can.
 Register TODAY for #CCH2018

Please contact IACP at [email protected] or 281.933.8400 with questions.

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