By: Armanda Dervishi, PharmD Candidate c/o 2027

Introduction

Compounding has always been an important part of pharmacy practice. Patients often need medications that aren’t available commercially – whether it’s a dye-free suspension for a child, a topical cream, or hormone replacement therapy. However, in recent years, compounding has received more attention than ever before. In 2013, Congress enacted the Drug Quality and Security Act (DQSA), redefining federal oversight of compounding pharmacies in response to public safety concerns. Since then, both the FDA and state boards of pharmacy have worked to strengthen regulations but figuring out how to balance safety with patient access hasn’t been easy.

FDA Oversight: 503A vs. 503B

The DQSA created two main categories for compounding: 503A and 503B. Pharmacies that operate under 503A only prepare medications for individual patients when there is a prescription and remain under the oversight of state boards of pharmacy. On the other hand, 503B outsourcing facilities can produce larger batches for hospitals or clinics, but they must register with the FDA and adhere to stricter manufacturing standards, such as Current Good Manufacturing Practices (cGMP).¹ The FDA hoped this would provide a clearer system for oversight, but it also created some gray areas. Many small compounding pharmacies feel they are being held to the same standards as large manufacturers, which can be expensive and difficult to manage. At the same time, others argue that stronger oversight is necessary to ensure sterility and protect patients.¹ 

The Mix of State Rules

While the FDA sets broad rules, states still play a huge role. Every state board of pharmacy imposes its own requirements for personnel training, documentation, and facility standards. Some have quickly adopted USP <795>, <797>, and <800>, while others are behind.² This inconsistency makes things complicated, especially for pharmacies that ship across state lines. A pharmacy might meet one state’s requirements but fall short in another. It highlights why better collaboration between states and the FDA is needed – federal rules provide consistency, but local boards have the knowledge to enforce standards within their communities.³

Politics and Legal Battles

Compounding has also become a political issue. The FDA has been criticized for overreaching when it comes to restricting compounded products. Hormone therapies, veterinary compounding, and office use medications have all been points of conflict between regulators, providers, and patient advocates.⁴ Lawmakers are divided as well. Some support expanding FDA authority to protect public health, while others believe that too much regulation could limit access to therapies patients depend on. These debates reveal how challenging it is to strike the right balance between safety and accessibility.

Looking Ahead

The future of compounding will likely be shaped by a few key developments:

1. Stricter Standards – USP updates, including changes to beyond-use dates and hazardous drug handling, are expected to be adopted by more states.²
2. More FDA Enforcement – Hospitals and health systems are turning to FDA-registered outsourcing facilities for sterile injectables. This trend may continue, raising questions about whether more 503A pharmacies will need to transition into 503B status ¹
3. Advancing Technology – Cleanroom automation, environmental monitoring, and new equipment can help reduce contamination risks. While expensive, these tools may become necessary as expectations for safety rise.⁵

Conclusion

Compounding is at a pivotal point. Pharmacists recognize the importance of personalized medicine, but stricter regulations and higher standards are transforming the practice. Both the FDA and state boards aim to protect patients, yet their overlapping authority often confuses pharmacies caught in the middle. As the profession advances, pharmacists will need to not only uphold evolving standards but also advocate for fair regulations that ensure customized medications remain safe and accessible to the patients who need them most.

References

1. Center. Human Drug Compounding Laws. U.S. Food and Drug Administration. Published 2024. Accessed September 3, 2025. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws?
2. Open Forum Session Proposed Revisions to USP General Chapter 〈795〉 Pharmaceutical Compounding -Nonsterile Preparations.; 2022. Accessed September 3, 2025. https://www.usp.org/sites/default/files/usp/document/stakeholder-forum/795-open-forum-01-12-2022.pdf?
3. Eddy E. Compounding Pharmacy Accreditation | USP Chapter 797 & 795. National Association of Boards of Pharmacy. Published October 16, 2024. Accessed September 3, 2025. https://nabp.pharmacy/news/blog/nabps-compounding-pharmacy-accreditation-shows-your-pharmacys-alignment-to-usp-standards/
4. Watson CJ, Whitledge JD, Siani AM, Burns MM. Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors. Journal of Medical Toxicology. 2020;17. doi:https://doi.org/10.1007/s13181-020-00814-3
5. Manon E. Innovations In Sterile Compounding Equipment: Enhancing Safety And Accuracy | AsepticEnclosures. AsepticEnclosures. Published July 26, 2024. Accessed September 4, 2025. https://asepticenclosures.com/innovations-in-sterile-compounding-equipment/

Published by Rho Chi Post