Know where your pharmacy needs improvement in all matters of compliance. Make cost-effective, prioritized adjustments.
Why Schedule A GAP Analysis? Learn More Below.
A small compounding pharmacy will be considered a pharmaceutical manufacturer if it falls short of just one of the conditions for exemptions outlined in section 503A of the Food Drug & Cosmetic Act. This means regulators will evaluate a pharmacy against the same CGMP requirements that large pharmaceuticals must abide by to stay in business.
With so many regulations, guidelines, and standards, it can be overwhelming trying to assess if your facility is in line with regulations. Are you prepared for the inevitable knock at the door? How can you ensure there are no gaps in your operation which may lead to costly outcomes?