In today’s society, medications are used and required for
everything from the discomfort of a mosquito bite to treat the symptoms and
unbearable pain associated with chronic disease. All forms of medication
undergo some form of testing, but it may be surprising to know what that
entails.
There are countless prescription medications on the market, but they all come down to two main categories: name brand and generic. There has been a lot of controversy over the categories for the past thirty years or so, most of which has been instigated by high yield name brand manufacturers. Myths regarding generic prescriptions try to make consumers believe there are major differences in the safety, strength, side effects, and healing time of generic versus name brand medications. However, the truth is quite simple. There usually is absolutely no difference other than price.
The FDA has extremely strict rules in accepting, overseeing, and testing medications. Generic medications are required to contain the exact same medication in the same amount as the named brand counterpart. For certain medications there may be up to a 3.5% difference in timed absorption rate, but everything else has to be equal. Microbiology quality assurance guarantees life-saving medications have been fully tested for potential health harming pathogens in either category.
Recently, due in large part to the quality control departments of smaller generic manufactures, some generic drugs are managing to get passed the FDA tests and actually fail to work as well as the name brand version. If you find that the case in your medications, contact your medical professional immediately. However, in most cases the only difference between the categories is that generic medications aren’t created in the big named factories and slapped with the giant price tag due to the flashy label.
The FDA holds both categories to the same safety testing procedures upfront, but generic medications are usually not required to participate in the expensive clinical trials required of their counterparts. This is due to the fact that name brand medications come out first and run all of those tests and trials ahead of generic options. Since the medications are the same, it’s scientifically unnecessary and a waste of time and resources to require generic trials. All a generic manufacturer needs to do is prove that their product is bioequivalent (performs identically) to the original drug. Not all name brand medications are available in generic form, but those that are typically are significantly less expensive versions of the name brand medication.
Over-the-counter medications are those available without a prescription. In the event of simple aches, pain, or first aid treatment, these items can be easily purchased without consulting a medical official. Most OTC’s are also overseen and regulated by the FDA through a type of recipe book known as OTC monographs. Manufacturers of the OTC brands submit their full ingredient list to the FDA in exchange for their approval. Tests are then performed to verify the listings. The tests for OTC’s are generally nowhere near as clinical as prescription medication due to the strength differences.
Obviously all OTC medications and supplements don’t pass the monographs. If the manufacturer refuses to submit their ingredient list or the medication otherwise fails FDA approval for any other reason, the product must go through a completely separate review process and apply for approval through the New Drug Approval System. In this case, more tests are performed, including human trials to ensure its claims are founded. Human beings are flawed by nature, however, and common sense is always a personal requirement. Regardless of what a bottle promises, use your head. You know your body. If something feels off, stop using it.
In the event of strong or common OTC medications, Pharmaceutical microbiology can play an important part in testing for contaminants. RMM methods utilize specific microbiology instruments to ensure the most reliable confirmation of pathogen readings in order to get the necessary products out onto the shelves as quickly as possible. Not everyone needs prescription medication for minor ailments, and in most cases it’s not needed. However, OTC’s are staples in almost every household. Medical technology is an amazing and constantly evolving miracle. Regardless of your medical needs, you can rest assured your microbiological tested and FDA approved medication is on the job. Contact Biolumix to learn more about rapid microbial methods for medications.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
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