Specialty Pharmacy (4.0) 4.0

OPS 4-3: Manufacturer and FDA Requirements

Submited by: Tom Goddard

The Basics

The focus of this standard is compliance.

First, the pharmacy must have a clear process for identifying and implementing applicable regulatory and manufacturer requirements (including FDA Risk Evaluation and Mitigation Strategy - "REMS" requirements). 

Second, the pharmacy must implement mechanisms to ensure that the staff complies with those requirements.

Finally, the pharmacy must implement a mechanism to contact patients and providers of new FTA or manufacture requirements that might impact patient safety.

Management Tips

Successful compliance with this standard will involve a combination of good policies and effective training.

Your policies need to have distinct processes for the components of this standard, replete with clear identification of who is responsible for each component and how that employee will implement the processes. Be sure the policies include all of the following:

  1. Identifying existing regulatory and manufacturer requirements;
  2. Monitoring regulatory and manufacturer requirements to detect any changes;
  3. Conduct monitoring and auditing activities to ensure ongoing compliance with FDA and manufacturer requirements; and
  4. A mechanism to contact patients and prescribers about patient safety-related changes in these requirements.

Accreditation Tips

Desktop Review

Submit policies that address all the components described above.

Validation Review


The reviewer will both interview staff members involved in tracking and monitoring compliance with regulatory and manufacturer requirements and observe implementation of those requirements.

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