The Prescription Drug Marketing Act (PDMA) was signed into law by President Ronald Reagan on April 22, 1988. Its purpose is twofold: to ensure that medicinal products purchased by consumers are both effective and safe to use, and to protect U.S. consumers from misbranded, adulterated, counterfeit, under-active, or expired prescription drugs. Prior to the establishment of the PDMA, legislators felt that U.S. consumers were unable to buy prescription drugs with the confidence and certainty that the medications were effective and safe. This was found to be a result of three factors:
- drugs which had previously been exported were being reimported into the U.S. as American Drug Returned
- prescription medication samples were being diverted
prescription drugs were being resold by healthcare organizations in bulk at prices below wholesale prices
The Pedigree Requirements
A prescription drug’s pedigree refers to its statement of origin and lists each sale, purchase or trade, when such transaction took place and the name and addresses of all parties involved in these transactions. Each person or entity who participates in the wholesale distribution of a prescription drug, that is neither the recorded manufacturer nor the authorized distributor of the drug, is required to provide the purchaser with a pedigree for that drug.
The PDMA Alliance
The PDMA Alliance Inc. is an organization that is dedicated to improving, developing and raising awareness of understanding of the PDMA. Among its members are a number of pharmaceutical executives whose businesses can be affected by prescription drug fraud, abuse issues and sample accountability. The alliance works in tandem with the FDA to provide up-to-date information pertaining to federal and state laws.
Contact our experts at Innovatum to find out more about how we can help you meet the challenges of FDA regulated labeling. Our ROBAR Enterprise Labeling Management System includes integration hooks to serialization technologies such as Systech and Seidenader which help to meet ePedigree goals. Contact us today to find out how we can help you meet your ePedigree needs.
Unique Device Identification (UDI) refers to a system that is designed to mark the labels of medical devices used within the healthcare system. The U.S. FDA released a final ruling on the system in 2014. The system is intended to be fully implemented over the next several years. Continue reading
10 Things to Know
21 CFR Part 11 is a section of Title 21 of the Code of Federal Regulations that authorizes the U.S. FDA rules and regulations related to electronic records and electronic signatures (ERES). It outlines the criteria which designate ERES to be a reliable equivalent to paper records. Here are ten important things you need to know about 21 CFR Part 11. Continue reading
Meeting GS1 Barcode Labeling Requirements
GS1 barcode labeling can be an essential component of accurate supply chain management. Without GS1, many companies in a variety of industries may find it nearly impossible to track shipments and identify products as they make their way through the vast network of transportation channels that funnels goods throughout the world. Meeting the GS1 barcode labeling requirements is one way for a company to prevent loss of products and to comply with industry logistics standards. Continue reading
The Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device. Continue reading
The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most significant changes is the elimination of the requirement that all implantable medical devices—such as pacemakers and heart valves—have the UDI printed on the device itself. Originally the proposed rule required manufacturers to mark the UDI directly onto the following types of devices: Continue reading
The U.S. Food and Drug Administration (FDA) has established a unique device identifier system(UDI) to facilitate the identification of medical devices. UDI guidelines specify proper usage of the unique device identifier in both human- and machine-readable forms and are intended to enhance the safety of healthcare workers, patients and caregivers. Manufacturers of medical devices are required to enter each device’s information into the FDA’s Global Unique Device Identification Database (GUDID), which will enable the public to search, access and download information about specific devices. Continue reading
A medical device is an instrument, appliance or piece of software designed by the manufacturer to be used for one or several of the following purposes: Continue reading
The first phase of the FDA’s unique identification (UDI) system began on September 24, 2014. This marks an historic point in medical safety. The purpose of the UDI is to give the labels of medical devices a unique number or code that enables the device to be easily identifiable by healthcare workers, patients and caregivers. Those responsible for labeling devices must also submit information about each device to the FDA’s Global Unique Device Identification Database (GUDID). This database is open to the public and enables anyone to search and download details about medical devices. Continue reading
The Food and Drug Administration (FDA) has set specific standards for the labeling of medical devices. It is vital that medical devices are labeled clearly and concisely to ensure that healthcare providers, patients and caregivers are able to understand the labels and use the devices in a safe and appropriate manner. Continue reading