Compounding Pharmacies

Compounding Pharmacy Compliance


Compounding Pharmacies are facilities that use practice of combining, mixing or adjusting the ingredients of a drug to create medications capable of meeting individual patient needs. These pharmacies provide a beneficial service to many patients. For example, they make it possible for a patient with an allergy to an ingredient in a drug approved by the U.S. Food and Drug Administration (FDA) to receive the treatment they need.


Compounding pharmacies produce drugs that benefit many patients with unique medical needs. However, there are risks associated with drug compounding, as well. As compounding pharmacies and facilities grow in number, the FDA has taken steps to mitigate risks to the public, including by implementing policies and regulations specific to compounding and by continuing risk-based investigation of compounding facilities. The FDA has begun placing more emphasis on compounding pharmacy compliance, and the regulatory landscape in this sector will continue to evolve in 2021 and beyond.


Regulatory Compliance Associates has provided support for compounding pharmacy clients facing Warning Letters, FDA 483 observations, and Consent Decrees for many of the largest compounders since the most recent FDA guidance went into effect in 2018.  We are actively supporting multiple 503B clients, and have worked with over ½ of the top ten compounders in the United States.


FDA’s Approach to Compounding Pharmacies 


In 2018, the FDA released its Compounding Policy Priorities Plan. This statement outlined how the administration would apply portions of the Drug Quality and Security Act (DQSA) and other regulations to compounders moving forward. This plan revealed an important insight for companies that perform compounding: compounded drugs produced in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act are exempt from certain current good manufacturing practice (CGMP) and labeling requirements, while compounded drugs produced outside of section 503A standards or in any outsourcing facility are not.


For companies that produce compounded drugs, this means the steps necessary to remain in compliance depends on the type of facility involved. Outsourcing facilities, for example, must meet all federal CGMP and labeling requirements. Furthermore, regardless of facility type, all compounding pharmacies must prepare, package and hold compounded drugs in sanitary conditions.


Achieving Compliance at Your Compounding Pharmacy


In recent years, the FDA has made efforts to improve the safety and quality of compounded drugs, conducting hundreds of investigations, issuing warning letters and overseeing more than 150 recalls of compounded drugs since the enactment of the DQSA. It’s in every company’s best interest to stay in compliance.


Compounding pharmacies is a growing segment of the industry with continuing emerging regulations. The ever-evolving landscape of industry regulations requires strict monitoring of quality standards. Regulatory Compliance Associates® is a leader in both aseptic drug manufacturing and the compounding pharmacy industries. Our regulatory experts can guide these entities to ensure they demonstrate compliance with new federal compounding industry regulations and meet the most Current Good Manufacturing Practices (cGMP) guidance requirements.

Regulatory Compliance Associates® can also prepare and train personnel in the management of FDA follow-up inspections. Regulatory Compliance Associates®  can help your company strategically address regulatory issues and help you establish a robust quality system designed to meet current FDA expectations for 503b compounding pharmacies. We do this through:


  • Comprehensive Baseline Reviews
  • Review and Guidance with Product Labeling Requirements
  • Preparation, Management, and Response to an FDA Inspection
  • Remediation
  • Re-engineering of a Facility (if needed)
  • Development and Documentation of Processes and Procedures


About Regulatory Compliance Associates


Compounding PharmacyRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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