by Jessica Williford MSHS, CEHT

Created on: March 14, 2011   Last Updated: March 15, 2011

There are Federal regulations for labeling over the counter (OTC) drugs sold in the United States.  On February, 27th, 1997 this law came into effect where the ‘FDA proposed a rule that would establish a standardized format for the labeling of OTC drug products’ (FDA, 2010).  These regulations outline what expectations companies have when making their medications and what the requirements are for the medication labels that consumers read.  After the medication labeling requirements were released, there were further labeling requirements needed, which were outlined and specified in 1999 under the “

Human Drugs; Labeling Requirements: Final rule.”  This lists the standardized format for medication labeling, as well as standard content to be listed on medications.

Over the counter drugs have become an important necessity for consumers in the US, making up a large part of medications used nationwide.  “Today, six out of every ten medications bought by consumers are OTC drugs” (FDA, 2010).  There are around 80 classes of OTC drugs that the Food and Drug Administration monitors and reviews instead of individual brands.  This allows the reviewing process to be more effective, with the large demand of individual OTC drugs marketed. 

There is a Nonprescription Drug Advisory Committee which meets and discusses issues that arise for over the counter drugs as they occur.  They make decisions and have made important changes to OTC drugs as a result.  Each approved OTC drug has a monograph, which is comparable to a “recipe” book of all the ingredients and specification of the OTC drug created and put into the Federal register.  Monographs are listed in the Code of Federal Regulations in Section 300.  Then once monographs are recorded, the manufacturer will be able market their OTC drug.

Unlike prescription medications, non-prescription OTC drugs are able to be marketed without FDA approval once their formulations meet the monograph requirements and are recorded.  However, OTC drugs that do not meet the monograph requirements will need to be reviewed by the new drug application (NDA) process.  The New Drug Application has been used for the approval of all drugs before they are marketed for use and sale to consumers in the US since 1938.  The NDA screening process requires that the manufacturer provide all clinical test studies conducted, research, ingredients, medication affects on the body and any other pertinent information.  In general, an overall picture of the new OTC must not be provided to meet criteria and pass the NDA screening process.

References

FDA.gov (January 5th, 2011). Drug Applications for Over-the-Counter Drugs, FDA.gov, Retrieved on March 15th, 2011 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications /Over-the-CounterDrugs/default.htm

FDA.gov (August 20th, 2010). New Drug Application (NDA), FDA.gov, Retrieved on March 15th, 2011 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications /NewDrugApplicationNDA/default.htm

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