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Pharmaceutical Manufacturing and Packing Sourcer
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The legal side of the pharmaceutical industry continues under the constantly moving cogs of manufacturing, distribution, drug delivery, and everything in between.
We spoke with legal experts from Quarles & Brady Health Law Practice Group to understand the major impact that COVID-19 has posed to pharmacies, legal processes, and the expectations for the year ahead.
PMPS: On reflection of 2020, what were the key compliance challenges For pharma manufacturing and pharmacies?
Quarles & Brady Health Law Practice Group: From a legal perspective, entities within the drug distribution chain, including manufacturers, wholesalers, and pharmacies, will need to track and understand the myriad executive orders and regulatory policies that were enacted during the pandemic. Most of these executive orders and policies were enacted in 2020 in response to the public health emergency and waived certain regulatory requirements across the industry. This may have included waivers of licensure for out-of-state entities and expanded permissibility for work from home and remote operations to name a few. Entities, in large part, have taken advantage of these waivers and instituted large-scale operational changes to their businesses. As the pandemic draws to an end (whether in 2021 or beyond), entities will need a keen understanding of whether such waivers are still in effect, as continued operations under expired waivers risks disciplinary action from regulatory bodies.
Looking forward, how do you think this will change in 2021 and beyond?
In many respects, 2020 was a grand experiment for the industry. In response to the regulatory waivers that were put in place in 2020, companies have implemented large-scale operational changes to their business. These changes have led to efficiencies with no major impact on patient safety. We anticipate that many regulatory bodies will move to make certain waivers permanent and relax otherwise antiquated regulations governing the industry. For example, many states in the US have already begun to propose and adopt rules permitting remote prescription processing and pharmacy operations where such operations might have otherwise been prohibited in the past. In contrast, as noted above, many states that have chosen to relax regulations during the pandemic will not act to make such moves permanent. As such, the regulatory landscape will revert back to pre-COVID-19 restrictions, testing businesses with multi-state operations.
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Roger Morris, a partner in the Quarles & Brady Health Law Practice Group, is a registered pharmacist who focuses on representing the full range of pharmacies in regulatory compliance and transactional matters, as well as health care providers.
Susan Brichler Trujillo, a partner in the Quarles & Brady Health Law and Litigation & Dispute Resolution Practice Groups, counsels clients across the pharmaceutical drug and device distribution chain on operating successfully within the highly regulated industry.
Nick Meza, an associate in the Quarles & Brady Health Law Practice Group, works with retail, specialty, and long-term care pharmacies, pharmacy benefit managers, specialty pharmacy HUBs, and wholesale drug distributors on a variety of regulatory and transactional matters.
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Roger Morris |
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Susan Brichler Trujillo |
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Nick Meza |
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