Reminder: If a state does not enter into an MOU with FDA, compounding pharmacies in that state may not cause more than 5% of their total compounded products to be distributed interstate

[PDF]Jane Axelrod – MOU With the States Under Section 503A [DRUGS]
www.fda.gov/.../drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm393648.pdf - 20k - Text Version
Memorandum of Understanding With the States Under Section ... Page 2. Purpose
of MOU Provision ... compounding and conventional manufacturing ... 

[PDF]Pharmacy Compounding of Human Drug Products Under ... [DRUGS]
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377052.pdf - 58k - Text Version
... demonstrable difficulties for compounding (difficult-to ... 4. Memorandum of
Understanding Between FDA and the ... states that have not signed the MOU. ... 

More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

View Presentation

File Format: PDF/Adobe Acrobat

Act places pharmacy compounding under the exclusive ... the pharmacy compoundsproducts for “office use.” .... If a state does not enter into an MOU with FDA,.

https://www.nabp.net/system/rich/rich_files/rich.../campbell.pdf