Compounding pharmacies are a very unique aspect of cleanroom usage. These types of cleanrooms typically make different kinds of pharmaceutical products and are held to a strict standard of cleanliness, referred to as USP 797. These types of cleanrooms must uphold to a strict cleanliness standard, as contamination could have potentially deadly effects.
Due to problems with contamination in these rooms in the past, several meningitis outbreaks have occurred. In order to prevent future outbreaks like this, Congress is looking to pass a bill that will help clear up some of the gray areas of the law. State laws regulate local pharmacies, and the FDA regulates the manufacturing of medicine. The bill will increase the authority of the FDA to regulate those smaller manufacturers that have grown to large scale production resembling manufacturers, while not requiring smaller pharmacies to register with the FDA. Registering with the FDA does come with some extra regulations and inspections, but pharmacies do have the option of voluntarily being regulated.
At Allied Cleanrooms we can build a variety of different types of cleanrooms, including USP 797- compliant rooms. Contact us today to speak with one of our cleanroom specialists.
hat tip: Washington Post