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Noticed Rules

Various Rules Intended to Combine Requirements for the Compounding of Drug Products Into a Single Chapter

Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy hereby gives Notice of Intended Action to amend Chapter 3, "Pharmacy Technicians," Chapter 6, "General Pharmacy Practice," and Chapter 7, "Hospital Pharmacy Practice"; to rescind Chapter 13, "Sterile Compounding Practices"; and to rescind Chapter 20, "Pharmacy Compounding Practices," and adopt a new Chapter 20, "Compounding Practices," Iowa Administrative Code. The proposed amendments are intended to combine the requirements currently in Chapters 13 and 20 for the compounding of drug products into a single chapter, Chapter 20, that fully adopts national minimum practice standards for compounding found in General Chapters 795 and 797 of the United States Pharmacopeia (USP). The proposed amendments also incorporate new federal regulations as established in the Drug Quality and Security Act of 2013, also known as the Compounding Quality Act, with respect to compounding and outsourcing facilities. Current Chapter 13 will be rescinded and reserved.

Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m. on May 15, 2015. Such written materials may be sent to Terry Witkowski, Executive Officer, Board of Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688; or by E-mail to terry.witkowski@iowa.gov.

Last updated: May 29, 2015 2:03 PM

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