As FDA labeling evolves, telehealth scales, and demand for customized hormone therapy grows, pharmacies and outsourcing facilities face new expectations. The next era of menopause care will depend on infrastructure capable of supporting consistent, well-coordinated, personalized hormone therapy services at scale. Here’s what every 503A pharmacy, 503B outsourcing facility, and telehealth organization needs to anticipate next.
Read MoreCleanrooms must be purpose-built in order to achieve regulatory compliance and quality assurance. A retail pharmacy with plans to squeeze in a small area to prepare TPN or specialty IV compounds may find out the hard way that there was not enough space allotted to promote operational efficiencies. Similarly, a 503A pharmacy looking to convert to a 503B outsourcing facility may be in for a rude awakening to learn that cleanroom designs and space requirements are vastly different for each entity. However, the following principles hold true for most cleanroom layout design and cleanroom construction planning:
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