Introduction

According to the FDA, pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. In most circuits within the United States today, compounding pharmacies are within state regulations and are not mandated by the FDA to undergo vigorous testing like drug companies. The FDA has enacted guidelines, however, for the compounding pharmacies to follow in order to help regulate the safety of the population.

Background

Ameridose is a large compounding facility whose goals are to “produce admixed preparations of the very highest quality and to deliver those preparations to hospital pharmacies quickly and reliably.” Its facility is located in Westborough, MA, and is a sister company of the New England Compounding Center (NECC) that was shut down recently due to unsterile methylprednisolone for injection contaminated with fungi. Both companies are run under the same family business and have faced problems with the FDA. An audit of Ameridose was run by the FDA in October 2012 shortly after NECC was shut down for dispensing a product that harmed and killed patients. After examination of the site, the FDA recommended that the site recall all products produced by Ameridose, and Ameridose obliged. The reason for this recall was to comply with the FDA in their effort for better sterility testing. However, after investigation of the facility, the FDA did not find contaminants in the products, nor have any of Ameridose’s products caused harm to the general public thus far.

Issue

Should Ameridose have voluntarily recalled all of their non-expired products?

Rules

Ameridose should have recalled their products if one of the following are met:

1. Ameridose products have caused death or serious harm to people.

2. There are impurities in their products that have the potential to cause serious harm to people.

Analysis

The investigation by the FDA in the later months of 2012 found no reports of patient infection or death caused by any of Ameridose’s products. After some investigating, the FDA did not find any adulterated or infected products produced by Ameridose. Therefore, Ameridose had been producing admixtures correctly. With no impurities in their product, Ameridose did not have the potential to cause serious harm to people.

Conclusion

After some investigation, the products of Ameridose did not cause death or harm to any of its consumers, nor did any of its products have impurities or adulterations that had the potential to cause harm to people. Therefore, Ameridose should not have recalled all of their non-expired drug products.

For more information on this issue, contact the Kulkarni Law Firm.