Regulation #16A-5419: Compounding

Updates regulations to incorporate developments and improvements related to safe, sterile practices and procedures for the compounding of pharmaceutical products.

Regulation Details
IRRC Number 3163 Proposed Regulation Received March 01, 2017
Agency Name State Board of Pharmacy PA Bulletin Publish Date March 11, 2017
Regulation Status Final-Form Close of Public Comment April 10, 2017
PA Code 49 Pa. Code Chapter 27.1
49 Pa. Code Chapter 27.12
49 Pa. Code Chapter 27.601
49 Pa. Code Chapter 27.264
Final Due By April 10, 2019
Analysts Assigned Fiona E. Cormack  (FEC)
Michelle L. Elliott  (MLE)
IRRC Comments Due May 10, 2017
Final-Form Regulation Received April 09, 2019
Public Meeting Date May 16, 2019
Published as Final N/A
Actions Taken
No IRRC Actions taken at this time

  • Proposed Regulation
  • Final Regulation
  • Related Documents

Public Comments on Proposed Regulation

April 12, 2017

April 12, 2017

April 12, 2017

April 11, 2017

April 6, 2017

Legislative Comments (on the Proposed and Final Regulation)

May 1, 2017

IRRC Comments on Proposed Regulation

May 10, 2017

Public Comments on Final Regulation

There are currently no public comments on the final regulation.


Legislative Comments (on the Proposed and Final Regulation)

HPLC May 1, 2017

IRRC Order(s)

There are currently no IRRC orders.


In addition to comments, IRRC occasionally receives other correspondence and written materials from state agencies and the legislature regarding pending regulations. These documents can be found on this portion of our website.

RAF 22 EXISTING FORM April 10, 2019