May 2016 – Understanding the latest FDA draft guidance regarding sterile compounding

In April, the FDA released three new draft guidance documents, intended to add clarity around 503A, 503B, and health-system sterile compounding. The 90-day period for comments back to the FDA on this language is already underway. Each of these proposed revisions have a pronounced impact on health-system pharmacy cleanroom practices and purchasing decisions. A copy of each are included for your reference. Here is a brief summary of each document:

1. Facility Definition of 503B- This one is most impactful to those anticipatory compounders/outsourced facilities registered as a 503B or considering registration. Essentially, the FDA does NOT want to see a 503B (anticipatory manufacturer) also participating in 503A (patient-specific compounding) in the same physical plant. The rationale is that items made under 503B must meet strict, current good manufacturing processes (cGMP) while products made pursuant to a prescription need only meet appropriate USP 797 and related standards. The concern is these process could co-mingle. The draft language states that if a facility still chooses to make both 503B and 503A in the same location, ALL products made will be held to the stricter rigors of cGMP/503B. Therefore, if you are evaluating outsourced facilities, make sure you ask the question. Best practice would be to focus on either 503A or 503B and not both in the same location. The only exception would be if the facility can prove that ALL products meet cGMP. Such suppliers do exist, but they are the exception and not the rule.

2. Prescription Requirements of 503A- FDA expands upon previous language in this document to remind providers that a patient-prescriber-pharmacy relationship must exist and that a patient-specific prescription is received prior to dispensing. Compounding in ANTICIPATION of a written order or prescription is acceptable under 503A with several restrictions including the need for this to be of “limited quantity”, no greater than a 30 day supply, Such compounding should be for “own use” or “office supply” within the health system and its affiliates such as physician office practices and clinics.

3. Hospital and Health System Pharmacy Compounding- This guidance is the one that will likely draw the most comments and concerns. It re-states everything mentioned in #2 above regarding the requirements for a patient-prescriber-pharmacy relationship. However, the FDA goes deeper into limitations on batch compounding. Beyond the “limited quantity” rule which is rather vague, the FDA is suggesting a best practice is that anything compounded in batch should not be distributed beyond a 1-mile radius from the pharmacy from which it was made. This will pose a significant issue for health systems that have centralized their cleanroom operations or are in the process of doing so. The intent is to keep the batched products “on campus”. Again, these are still in the DRAFT phase pending feedback from thought leaders.

Electronic comments should be submitted to the FDA at

I strongly encourage each of you to carefully read each guidance in detail, make notes, and flood the FDA with your thoughts.

Best regards,

Chris Jones, RPh

Chris Jones is Director, Pharmacy Automation & Technology at Premier, Inc. Chris has extensive automation and pharmacy leadership consulting experience. You may contact Chris by leaving a message in the contact us box below.

The guidelines can be access here or on the FDA website.

FDA Guidance 503A and 503B must be in separate facilities FDA

Guidance_Hospital and Health System Compounding_ucm496288 FDA

Guidance_Prescription Requirement_ucm496288


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