CIS

Building a Drug or Device Sampling Program that is Compliant, Accountable, and Prepared for Federal and State Law


Within the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance), three key risk areas are identified. One of the key risk areas is compliance with laws regulating drug sampling. With the enforcement of drug sample transparency spawned from implementation of §6004 of the Patient Projection and Affordable Care Act (PPACA), manufacturers are giving renewed attention to the Prescription Drug Marketing Act of 1987 (PDMA). This law, passed by Congress in 1988, is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired drugs as a means to help ensure the safety and effectiveness of those drugs. The PDMA mandates that pharmaceutical companies implement specific accounting policies and procedures, auditing and monitoring protocols, and thresholds. Civil and criminal penalties are also established for individuals and corporations found guilty of noncompliance with the law.
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In The Headlines

PCI Synthesis

Embracing the Good and Avoiding the Bad and the Ugly in Pharma Manufacturing


Good manufacturing has always been about paying attention to the details. But now, thanks to competition, global sourcing, a higher compliance bar and increased regulatory scrutiny, there are more details to worry about than ever.
 
Some projects require thousands of steps towards completion. Under this new complexity, in which analyzing is as important as the manufacturing, the main manufacturing goal is to reduce the number of issues that can disrupt completion, which can range from major to minor. It’s important to realize that minor details, which once might not have represented issues before, can turn into a problem.
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Topic of Discussion

PDMA Alliance

The PDMA Alliance: Improving the Understanding of Drug Distribution Laws and Regulations

The annual Sharing Conference began over twenty years ago when a group of pharmaceutical executives came together to discuss the impact that the Prescription Drug Marketing Act of 1987 was having on their everyday responsibilities related to sample accountability. This group came to be known as The PDMA Alliance, a not-for-profit organization that presents an annual “Sharing” Conference for a diverse membership of industry executives and vendor partners. Conference registration is enhanced with the addition of year-round membership benefits for all participants, accessible through the Alliance website. Alliance membership and conference participation have been extended to include the medical device community, a sure sign of the organization’s ongoing outreach and continuing growth.
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