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Prescription Labeling Requirements

Updated February 21, 2017

The process of prescribing, dispensing and using medications leaves little room for medical errors when the health of the consumer is at stake. This, coupled with the need to keep track of medication supplies, required a system to be put in place. Prescription labelling requirements are set up to reduce the likelihood of medical errors, as well as to provide consumers with needed information regarding medications in the marketplace.

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Health information as presented by medical professionals is often complicated and difficult for consumers to understand. Prescription labelling requirements were put in place to better ensure consumer safety and prevent the unauthorised manufacturing and distribution of pharmaceutical drugs. These provisions are meant to provide for easy access to prescription information by simplifying drug labels and usage instructions. Current legislative measures work to reduce illegal distribution channels by requiring standardised packaging processes and allowing only authorised professionals to distribute them.


The Federal Food, Drug and Cosmetic Act of 1938 set up assigned classifications for different drug classes. Prescription drugs were assigned their own classification that held specific requirements for distribution and usage. Requirements for packaging designate what type of information should appear on the label. Any medications dispensed to patients must list the pharmacy name and address, the date of the prescription, the name of the prescriber, the name of the patient, and the prescription serial number on the package label. Also listed is a federal warning forbidding any type of drug transfer, meaning only the person it was prescribed for is permitted to use it.


As of 1998, the Prescription Drug Marketing Act was instated to assist consumers and professionals with the safe handling of pharmaceutical drugs. This act required the name of the drug, dosage amounts, possible side effects and dosage instructions to be clearly listed on the label. By 2006, additional provisions were put in place by the U.S. Food and Drug Administration (FDA) requiring medications to be dispensed with package inserts. Inserts contain easy-to-read instructions that emphasise the most important information about the medication.


The updated provisions made in 2006 made it possible for the FDA to integrate the new prescription labelling requirements into their e-health initiatives project. The e-health initiatives project created an electronic archive of records that lists all prescription medications as well as their assigned uses. This information can now be accessed through electronic prescribing tools used by doctors, hospitals and pharmacies. Consumers can also obtain medication information online through the National Library of Medicine's database. The online archive is an up-to-date database of current and new medications being prescribed within the U.S.

Additional Measures

As of early 2008, the American Society of Consultant Pharmacists Foundation and the American Foundation for the Blind put together guidelines for prescription labelling requirements to provide the visually impaired population with the same protections as those who are not visually impaired. These guidelines provide specific directives for pharmacists on how to prepare important labelling information for those who are visually impaired. Also included are resources listing the types of assistive technology and services available to help those with visual impairments access drug information.

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About the Author

Jacquelyn Jeanty has worked as a freelance writer since 2008. Her work appears at various websites. Her specialty areas include health, home and garden, Christianity and personal development. Jeanty holds a Bachelor of Arts in psychology from Purdue University.

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