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Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
September 10, 2021  |  Volume 18  |  Issue 36
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
The FDA and Pharmacy Compounding
FDA Form 483, Part 8

FDA 483 Observations in 503A Facilities

In this issue, we will look at FDA 483 observations in 503A facilities in categories 7 through 10.

  1. Personnel
  2. Facility
  3. Equipment
  4. Environmental Monitoring
  5. Cleaning, Disinfecting, and Deactivating
  6. Compounded Product Quality
  7. Unapproved Components
  8. Insanitary Conditions
  9. Complaint Follow-up
  10. Administrative and Regulatory

7. Specific Issues - Unapproved Components

  • Your firm compounded drug products that are not the subject of an applicable USP or NF monograph, are not components of an FDA-approved human drug, and do not appear on the 503A bulks list.

8. Specific Issues - Insanitary Conditions

  • Your firm prepared, packed, or held products intended or expected to be sterile under insanitary conditions.
  • Your firm compounded drug products intended or expected to be sterile as well as non-sterile drug products that were packaged or held under insanitary conditions, when they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated.

9. Specific Issues - Complaint Follow-up

  • Following a complaint of particles in a reconstituted injectable, your firm failed to perform a risk assessment assessing the impact and to take corrective actions, if indicated.
  • Your firm had a sterility failure but failed to take appropriate corrective actions; to perform a risk assessment assessing the impact on other batches and to take correct actions, if indicated.
  • Your firm, after identifying actionable microbial contamination during routine recertification within the ISO 5 aseptic processing area, released for distribution drug products produced in this area prior to any additional cleaning and disinfection of the aseptic processing area. An evaluation of the impact of the environmental microbial contamination on the sterility assurance of the finished product was not conducted.
  • Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

10. Specific Issues - Administrative and Regulatory

  • Your firm compounded drug products that failed to meet the conditions of section 503A as they are not etc.......
  • Your firm failed to conduct at least one test to verify the identity of each component of a drug product.
  • Your firm failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals.
  • Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.
  • You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.

Even though from the inspector's comments it is evident they are not necessarily the "tops in their class" in compounding knowledge and accurate reporting, they should at least "proofread" their reports for accuracy, both in content and in grammar.

It is evident in looking through these 483 observations that in some pharmacies there have been issues with the facility, equipment, standard operating procedures (SOPs), personnel, drug quality, stability, and/or sterility. It is difficult to know exactly the source of the observations, as follows. Is it due to:

  • lack of education on the part of the pharmacist or technician? (Compounding pharmacists are not trained in college at the level expected for full compliance with cGMP requirements; this is generally learned after graduation.)
  • lack of oversight on the part of the pharmacist in charge?
  • a temporary lapse of judgment of the compounder?
  • an excessive workload?
  • inadequate equipment to perform the required tasks?
  • lack of SOPs or their implementation?
  • temporary situations that ordinarily do not occur in the pharmacy?
  • miscellaneous causes not covered above?

We must also mention the following issues that can lead to 483's from the standpoint of the individual doing the inspection.

  • Many inspectors have spent their career inspecting big PHARMA companies, which include an army of personnel at the company involved in manufacturing and specific staff to assist the inspectors. One would not expect the same level of scrutiny and requirements to be applied to a much smaller organization with limited personnel, limited output, etc. that handle individual prescriptions and not hundreds of thousands of units.
  • Some stories have come to light where the inspector(s) have said, "I don't see anything really wrong but I have been told to stay here until I do!"
  • Some inspectors have been "taught" over the years that "compounding is dangerous and shouldn't be done!", and that attitude is not impartial but quite biased in the inspections.

Considering all the above, the positive aspect is that as these issues are addressed, quality increases. Much has been learned since DQSA was passed. Financially, DQSA has necessitated large expenditures for facilities and equipment and in 503a pharmacies and 503b facilities; also, in the case of 503b facilities, a lot of money in fees are being paid to the FDA each year.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

 

Did You Know ...

...that E.C. Stowe said the following?

"Common sense is the knack of seeing things as they are and doing things as they ought to be done."

 

Thoughts of the Week (On Common Sence and Knowledge)

Common Sense is a Punishment

Source: Provided by and thanks to Pharmacist Kim Ruthig of Ontario, Canada.

"Whoso neglects learning in his youth loses the past and is dead for the future." (Euripides)

"Knowledge is of two kinds. We know a subject ourselves, or we know where we can find information upon it." (Samuel Johnson)

"The more extensive a man's knowledge of what has been done, the greater will be his power of knowing what to do." (Disraeli)

"All wish to possess knowledge, but few, comparatively speaking, are willing to pay the price." (Juvenal)

 

IJPC Coming Soon

IJPC's September/October 2021 Issue is Coming Soon and Includes:

  • Five Feature Articles
  • Ten New Formulations
  • Three Applied Compounding Articles
  • Three Peer-reviewed Stability Studies
  • Editorial on "Permissible Exposure Limits and United States Pharmacopeia Chapter <800>"
  • And More

The Journal is indexed by MEDLINE/PubMed and many other services!! Subscribe today to receive your print copy with digital access to all subscribed issues at IJPC.com!

 

Looking Back

To change that
Shaving job to joy,
You gotta use the
Real McCoy!
     Burma-Shave

 
 
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