The Compliant Landscape of Compounding Pharmacies

compounding pharmacies compliance

Blue Mountain recently conducted market research of the Compounding Pharmacies industry. From our research, we sought to uncover areas of the manufacturing process that require a more advanced solution for ensuring GMP compliance, as well as better understand how facilities are currently ensuring compliant manufacturing environments.

Key Insights

Following our secondary research of the industry, we held a focus group with employees from different compounding facilities on their asset tracking processes. Our responses told us that:

  • A large segment of compounding pharmacies are registered as outsourcing facilities under section 503B of the FDCA.
  • Of the respondents registered as outsourcing facilities, all have undergone FDA inspections.
  • All participants were from small facilities (having 100 or less pieces of equipment).
  • No one identified as having enterprise asset management software in place at their facility due to limited budget and size of company.
  • The majority of the way assets are tracked is with in-house databases and excel spreadsheets.


After analyzing the responses of our focus group participants, and comparing them to our secondary research, we were able to conclude a key insight:

All compounding pharmacies operate under FDA regulated environments. As the number of pharmacies opting to become registered outsourcing facilities and the number of FDA inspections in the Life Sciences industry continue to rise, compliance becomes more and more critical. Organizations must effectively track and manage their assets involved in the production process to ensure quality and compliance. A great solution for these companies is an enterprise asset management system (EAM). With an EAM designed specifically for the Life Sciences, similar to Blue Mountain RAM, compounding pharmacies can drive GMP compliance with features such as Part 11 work flows and automated OOT’s/failure notifications.



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