Behind the Scenes of PDA’s New Drug Compounding Interest Group

Arie Anahory and David Short are on an exciting mission to create a robust Drug Compounding Interest Group for industry peers. As co-chairs, they follow a successful Parenteral Drug Association (PDA) tradition of providing specialized interest groups for professionals offering them a safe space to share concerns, issues, successes and challenges in their day-to-day practices.  

The Drug Compounding Interest Group, available to anyone who wants to join, is the youngest of these professional communities and Arie and David are dedicated to making it relevant, dynamic and meaningful. They say they are also on an education mission: You need to educate people first and then bridge theories to practice. The compounding practice is one of continuous improvement, and the dedicated special interest group is designed to help shape its future.  

Leadership Expertise 

Both co-chairs are well-qualified professionally and super enthusiastic about their roles. Arie Anahory is Senior Director, XBU Strategy and Customer Excellence with a focus in providing industry-leading quality, regulatory, testing and technical consulting solutions to life-science clients facing challenges in processes of the product lifecycle. Her co-chair David Short is Chief Quality Officer at QuVa Pharma, Inc.  David has over 30 years of pharmaceutical experience and is knowledgeable in cGMPs specializing in parenteral drug manufacturing specifically with Quality and Research & Development. David has a strong background in operational excellence driving continuous improvement in processes and in people through coaching and training. 

Together they oversee the group and facilitate dynamic conversations and professional connections. Arie says her goal “is to encourage the compounding community and life science colleagues to engage in thought-provoking discussion on emerging regulations and challenges within the industry.” David adds “The group offers a platform within PDA to bring management and compounding expertise from a GMP vantage point as opposed to a pharmacy lens. PDA/FDA compounding training workshops offer a center of excellence for a reasonable fee.  Compounding should be an arm of the drug manufacturing world, so we need to get compounding work integrated with the manufacturing industry to learn by experience how to meet expectations and innovate in the compounding world.” 

Meet-Ups 

With two in-person meetings (at PDA Week and the PDA/ FDA Joint Regulatory Conference) and two virtual sessions to date, the group remains connected within an online forum 24/7 through PDA Connect, a chat tool designed to post questions, ideas and topics for the 82-member group. Arie adds, “The goal with our group is to start conversations, share best practices across the industry, and even fight for new technical documentation to provide clarity for compounding professionals.”   

Meeting Notes 

The Drug Compounding and Sterile Processing interest groups had a combined meeting during the Joint Regulatory Conference to focus on aseptic processing topics particularly as they relate to small batches/manual operations. Members discussed conducting aseptic process simulations (APS) on small batches that are conducted using manual operations, with the need to validate each operator performing the process given the variations resulting from fully manual and semi-automated processes. The new revision for PDA TR22 on APS contains considerations for small batch sizes and will be out next year. 

The meeting also covered how to establish an effective EM Sampling Plan using a robust risk assessment that includes facility, process, and product. Also, separating the process elements between setup, operation, and breakdown needs to be assessed so that each can be measured and trended separately. 

Disinfection efficiency was also discussed. Changeover is more frequent with small batch sizes, so an effective disinfection program is a critical requirement. There was a strong preference expressed among members for ready-to-use sterile disinfectants, with the caveat of the need to understand that they are being used correctly which includes having a robust process for measuring contact time. 

 Compounding Career Track 

The compounding profession requires an aseptic technique which is ultimately based on human expertise. It takes a particular talent to master the process of repetitive compounding time and time again. Arie envisions that the interest group will be helpful for compounding managers and leaders who struggle to hire and retain a workforce that performs a critical job dependent on continuous focus to detail. She says the challenge is to make compounding an attractive career choice, and the group can be useful in sharing their experiences on how to sustain the talent pool and make people aware of the critical role that compounding plays.  

Compounding Hot Topics 

David shares an important current issue: Hospital pharmacies, 503B Outsourcing Facilities, and Drug Product (DP) manufacturers have a synergistic relationship in the production of Ready to Administer (RTA) parenteral products.  

503B Outsourcing Facilities serve as an extension of hospital pharmacies by producing RTA parenteral products that were traditionally compounded in-house. Significantly, both 503B facilities and hospital pharmacies utilize the same drug product (DP) starting materials, emphasizing their mutual reliance. DP manufacturers serve as the primary raw material suppliers for both 503B Outsourcing Facilities and hospital pharmacies. 503B facilities supply hospitals with RTA products streamlining processes to reduce risk and cost while enhancing overall patient care in the hospital facility.   

By the application of cGMPs, the 503B is an extension of the drug manufacturer.  503B’s provide products in a format the drug manufacturer is not configured to do without intrusive changes to the manufacturing process and significant costs for initial and maintenance regulatory approval.  The 503B facility is the efficiency link between the pharmacy and the drug manufacturer, with application of FDA cGMP standards being the common link. The DP Manufacturers, 503B Outsourcing, and Healthcare industries need to foster dialogue on collaborative efforts with the FDA in advancing cGMP requirements, ensuring uniform confidence in 503B compounded parenteral products. 

There is an opportunity for the FDA to drive 503B’s to DP manufacturers’ requirements with cGMPs to improve resilience in these common areas and bolster product quality, reliability, and stakeholder confidence.  This will strengthen the mutual relationship between hospital pharmacies, 503B Outsourcing Facilities, and DP manufacturers, with a focus on enhancing RTA parenteral product quality and accessibility while navigating regulatory landscapes. This promotes a direction toward enhanced collaboration and patient-centric care. 

Participating Has Its Benefits 

One pathway to making a special interest group viable is to share success stories.  Arie says, “We don’t do that often enough. But we all need role models and a boost to celebrate our good work and results.” She adds that attending PDA conferences is a great way to get involved with industry peers and leverage experts who are out there to advance the industry. 

For anyone considering joining the group, Arie says, “Join us to bring forward discussions on emerging regulations and best practices and how to navigate the compounding regulatory landscape. You will increase your knowledge of the application of GMPs in daily operations. We are a community of industry colleagues that provide firsthand experience and knowledge to better prepare you for protecting patients with industry best practices for patient safety.”  David adds, “Who wouldn’t benefit from a free consultation with industry experts?  Where else can you get it?  There is a lot of innovative thinking for compounders and our group provides so much information and collaboration. Get in on the dialogue and share! You can make connections through the PDA Connect chat room in real time. You can meet up with other members -- not just compounders, but also professionals across the sector.” 

The interest group is open to all interested individuals. Being a PDA Member is not required. 

For more information and to join the PDA Compounding Special Interest Group, visit PDA’s website>