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What the FDA is Finding Industry Wide During 503B Inspections

  • FDA

Please Note: The following article pertains to industry wide Inspections and is not representative of SCA Pharma.

The healthcare industry is undeniably one of the most important sectors of the economy. Tasked with the responsibility of ensuring good health among the general public, the healthcare system has a vital role in ensuring the well-being of society.

One aspect of the healthcare system is that of compounding pharmacies. These pharmacies produce medications on a customized basis for hospitals that is based on their unique needs rather than mass producing it the way commercial pharmaceutical companies do.

Regarding governmental oversight of compounding pharmacies, there was a time when industry regulations were greatly lacking, compared to what exists today. While there were a few regulations, they were mostly managed by local health boards, as opposed a centralized organization such as the FDA.

It was not until the occurrences of serious contamination issues in the marketplace that the government decided to change the way the system was run. Contaminated medications that were being produced at compounding pharmacies led to the deaths of several people, and many more being adversely affected.

In response, the government decided to overhaul the system with regard to the way it functioned. The oversight and regulation of compounding pharmacies were transferred from the local health boards to the Food & Drug Administration.

In addition, compounding pharmacies were classified into two categories; 503A and 503B. While 503A pharmacies produce medication in small batches, 503B facilities produce similar, non-patient specific medications in vast quantities. These facilities are held to much higher standards.

The inspections of 503B pharmacies conclude that most facilities are in compliance with existing rules and regulations. The level of compliance has been steadily going up, while accidental contamination and other code violations have decreased.

Apart from the above, the issue of non-compliance still exists in a few facilities. There have been issues of code violations, much of which happen to be restricted to some concerns and issues which are discussed below.

1.) Lack of Sterility Assurance

One issue of concern is regarding the sterility of drugs manufactured and their environment.

Sterility refers to a general lack of microbial life present in the drugs. This includes everything from the machinery used, the floor of the facility, and everything in between, as the presence of microbial life to the degree of even a few cells will result in a massive contamination which is due to the speed at which they multiply.

2.) Drug Adulteration

Drug adulteration refers to the mixing of the medication with ingredients that were not part of the original formulation.

The mixing of these unwanted ingredients into the medication is usually done due to a variety of different reasons; ranging from reducing the input costs to increasing the final quantity of the drugs produced.

3.) Labeling Issues

As per FDA regulations, all drugs should be labeled in a clear and understandable manner, explaining to the end user the exact nature of the drugs. This includes a wide range of things, ranging from ingredients used to the facility details.

The facilities were found to have either mislabeled the medications with regard to their ingredients as well as necessary information about the facility.

4.) Insurance Fraud

While this is not related to the medications being produced, some facilities were found to have been indulging in insurance fraud to one degree or another.

The exact nature of the insurance fraud may vary depending on the case, but the FDA considers this malpractice nevertheless.

5.) Non-Living Contaminants

A lot of the drugs were found to be contaminated with non-living contaminants such as particulate matter.

While this may not cause infections due to the nature of the contaminant, they may have other adverse effects on the human body.

6.) Microbial Contaminants

Some medications were contaminated with live microbes.

The nature of this contamination is varied. However, some very common live contaminants were that of mold and other fungi species.

7.) Potency Issues

Medications produced are required to stick to certain degrees of potency.

What was found was that the actual degree of potency varied from that which was expected from the drug. While this may not cause any harm to the end user, the drugs will inadvertently end up not curing the patient of the illness he is suffering from.

8.) Expired Ingredients

The drugs used were found to be using ingredients that had expired or were in the process of being rendered as expired.

9.) Quantity Issues

Prescribed medication given should be of a certain quantity. However, the actual quantity was found to be different from the prescribed amount.

10.) General Production Environment Issues

The last issue is that of a fairly general nature – the facility where medications were being manufactured.

What the FDA found was that some 503B facilities were not having the required level of sanitation and quality that was expected as per existing norms and regulatory requirements.


As a whole, there are a variety of different discoveries – with the most crucial ones described above.

These findings and others just like it, are an indication that despite the various regulations that are in place to ensure that 503B facilities function smoothly, there is always room for improvement.

Furthermore, these discoveries, in addition to many others, are going to be helpful in understanding where the facilities have issues and how the same can be remedied in the most ideal way possible.

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