Pharmacies Skirt Laws to Increase Profits

There are pharmacies out there that buy raw ingredients in bulk and manufacture their own drugs rather than buy the final product from pharmaceutical companies. The drugs created in this manner are not approved by the FDA, not monitored for safety or potency, and bring with them a host of problems. But they can increase profits.

Stacey Lloyd writes:

Pharmacies are state-regulated, and therefore, are not required to meet the same quality and safety regulations that FDA-regulated pharmaceutical companies must abide by. Not only are compounding pharmacies not required to test their ingredients, but in most states, they don't even have to check the final products they have compounded for potency or sterility. Furthermore, compounding pharmacies are not required to report adverse events that patients experience with their drugs.

Pharmaceutical companies are required to follow strict regulations set forth by the FDA. During the manufacture of their drugs, pharmaceutical companies must validate their processes, manufacturing equipment and test methods to ensure that their drugs are manufactured in a quality controlled environment. They must perform extensive testing, especially when sterile drugs, such as respiratory drugs, are manufactured.

Pharmaceutical companies must also test the drug, equipment, and the environment in which the drug is manufactured to ensure it was manufactured in a sterile environment. Without this testing, there is no way to be sure that the drug is free of contaminants and will therefore, not cause further illness or disease to the patient. In addition, if a pharmaceutical company is notified of any adverse events to a drug, they are required to report it to the FDA. [emphasis in original]

As Lloyd explains, there are numerous cases where drugs compounded in pharmacies have been found to be unsafe: regulators have discovered bacterial contamination, unsterile conditions, mislabeling, and failures in potency tests. Sometimes neither doctors not patients are made aware of what is being done — pharmacies have even tried to trick doctors into allowing compounding.

There are complaints about the safety and efficacy of drugs imported from Canada, but there may be a much larger problem with the drugs you get at your local pharmacy — drugs that are less safe and reliable because of some people's desire to make more money from sick patients.

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