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Dear Colleagues -- I am pleased to share this update received from Mark Schloss (CHPA) noting that the bill (mentioned previously) to require dosage form manufacturers to register their tablet equipment is unlikely to go through mark-up, and thus chances of inclusion in any 2018 legislation is most unlikely. See attached correspondence. We will, of course, keep you posted. We think the threat level is certainly a DEFCON 4 or less.
Regards, LDI ---------- Forwarded message ---------- From: Schloss, Marc <mschloss@chpa.org> Date: Fri, May 18, 2018 at 1:21 PM Subject: RE: The Tableting and Encapsulating Machine Regulation Act of 2018 To: Michael McGuffin <MMcguffin@ahpa.org>, Gil Roth <gil.roth@pharma-bio.org> Cc: Bill Bookout <b.bookout@nasc.cc>, Mike Greene <MGreene@crnusa.org>, Kristen Blanchard <kblanchard@nutramaxlabs.com>, Pete Evich <pevich@vsadc.com>, "Stamoran, Cornell" <Cornell.Stamoran@catalent.com>, "Gay, John" <jgay@chpa.org>, "Spangler, David" <dSpangler@chpa.org>, Loren Israelsen <loren@unpa.com>, "Holgate, Taylor" <tholgate@chpa.org>, "Del Monte, Brent" <BDelMonte@bgrdc.com> Dear all – Yesterday we received the attached, updated version of the Kustoff tableting and encapsulating bill. Our read of the updated version of the bill is that it carves out legitimate actors so far as these legitimate parties are accurately keeping transaction records as they already are required to do by the DEA. In terms of process, as you are all aware, the House Energy and Commerce Committee just finished their markup of 57 opioid-related bills, so it’s hard to imagine this bill being included in that package, as Kustoff has not been marked up, but we wanted to make sure you saw the latest version and our read of it. Please let me know your thoughts, Marc Marc Schloss Vice President, Federal Government Affairs Consumer Healthcare Products Association 1625 Eye Street, NW, Suite 600 Washington, DC 20006 Phone: (202) 429-3533 Cell: (202) 368-7448 chpa.org | KnowYourOTCs.org From: Schloss, Marc Sent: Monday, April 23, 2018 2:55 PM To: 'Michael McGuffin' <MMcguffin@ahpa.org>; 'Gil Roth' <gil.roth@pharma-bio.org> Cc: 'Bill Bookout' <b.bookout@nasc.cc>; 'Mike Greene' <MGreene@crnusa.org>; 'Kristen Blanchard' <kblanchard@nutramaxlabs.com>; 'Pete Evich' <pevich@vsadc.com>; 'Stamoran, Cornell' <Cornell.Stamoran@catalent.com>; Gay, John <jgay@chpa.org>; Spangler, David <dspangler@chpa.org>; 'Loren Israelsen' <loren@unpa.com>; Holgate, Taylor <tholgate@chpa.org>; Del Monte, Brent <BDelMonte@bgrdc.com> Subject: RE: The Tableting and Encapsulating Machine Regulation Act of 2018 All – I wanted to let you all know that I just heard from E&C minority staff that the Kustoff bill will NOT be included in the E&C markup this week on opioids and therefore is not likely to be included in the larger opioid bill that will come out of E&C. I will certainly pass along more as I hear it, but wanted you all to know! Marc From: Schloss, Marc Sent: Thursday, April 5, 2018 9:03 PM To: Michael McGuffin <MMcguffin@ahpa.org>; Gil Roth <gil.roth@pharma-bio.org> Cc: Bill Bookout <b.bookout@nasc.cc>; Mike Greene <MGreene@crnusa.org>; Kristen Blanchard <kblanchard@nutramaxlabs.com>; Pete Evich <pevich@vsadc.com>; Stamoran, Cornell <Cornell.Stamoran@catalent.com>; Gay, John <jgay@chpa.org>; Spangler, David <dspangler@chpa.org>; Loren Israelsen <loren@unpa.com>; Holgate, Taylor <tholgate@chpa.org> Subject: The Tableting and Encapsulating Machine Regulation Act of 2018 All – Attached, please find the final version of this letter. Again, thank you all for your help, guidance and assistance with this letter. I will be sure to let you know any response we receive, Marc Marc Schloss Vice President, Federal Government Affairs Consumer Healthcare Products Association 1625 Eye Street, NW, Suite 600 Washington, DC 20006 Phone: (202) 429-3533 Cell: (202) 368-7448 chpa.org | KnowYourOTCs.org Comments are closed.
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