Distribution

Manufacturers and distributors of legend drugs, controlled substances, over-the-counter drugs and prescription medical devices must comply with a wide variety of licensing and operational requirements on the federal and state level.

Since the early 1990's, legislative bodies and regulating agencies for the federal and state governments have passed and implemented many statutory and regulatory requirements affecting the licensing, recordkeeping, storage and handling, and reporting requirements for legend drugs and controlled substances (prescription drugs). In order to efficiently conduct business throughout the US, manufacturers and distributors must find ways to stay current with this ever-changing regulatory landscape.

Analysis

Due to these requirements, life sciences companies may need to obtain licenses from various governmental agencies in order to ship prescription drugs, prescription devices or over-the-counter drugs. State agencies require an abundance of data, such as criminal background checks, personal information and employment history of the facility representative and/or officers, before issuing licensure. Your company could also be compelled to provide proof of a surety bond and 3rd party accreditation, and follow federal and state requirements for the proper storage of products, record-keeping and the tracking and reporting of theft and loss of products.

Trends

Over the last 25 years, the federal government has passed wide-sweeping legislation greatly affecting manufacturers and distributors. Legislation, such as amendments to the Prescription Drug Marketing Act (PDMA) and the Drug Quality and Security Act (DQSA), have brought a vast array of changes to the way manufactures and distributors are required to ship product, whether it be samples or trade product, throughout the US. In the past, changes at the federal level have sparked new, and sometimes stricter, requirements at the state level and it can be expected that this pattern will continue in the future.

How We Can Help

It is often difficult to stay current with these continuous revisions. PorzioLS provides an interactive, web-based compliance database which allows for quick access to constantly changing federal and state statutes, regulations and guidance documents. Our team daily researches, analyzes and summarizes these changes.

Additionally, we are able to apply our long-standing expertise in the distribution field to a multitude of projects and customized services, based upon your businesses' specific needs.

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