Scribd Logo
Upload

Welcome to Scribd!

  • DOPL Emails

    Uploaded by

    The Salt Lake Tribune
    7K views5 pages
    Correspondence between Dan Richards of Meds in Motion and state officials.

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    Correspondence between Dan Richards of Meds in Motion and state officials.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    7K views5 pages

    DOPL Emails

    Uploaded by

    The Salt Lake Tribune
    Correspondence between Dan Richards of Meds in Motion and state officials.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 5
    ‘State of Utah Mal-DOPL, Mark Steinagel DOPL Richards, Dan Wed, Apr 15, 2020 at 5:25 PM To: Stuart Adams , Mark Steinagel , Evan Vickers Co: *val.peterson Gentlemen, | just received a call from DOPL telling me that what I was doing was in violation and if | persisted | would be cited. Jennifer Healy cited below: (3) Facilities engaged in simple, moderate or complex non-sterile or any level of sterile compounding activities shall maintain proper records and procedure manuals and establish quality control measures to ensure stability, equivalency where applicable, and sterility. The following requirements shall be met: (a) Facilities shall follow USP-NF Chapter 795, compounding of non-sterile preparations, and USP- NF Chapter 797 if compounding sterile preparations. (b) Facilities may compound in anticipation of receiving prescriptions in limited amounts. (c) Bulk active ingredients: (i) shall be procured from a facility registered with the federal Food and Drug Administration; and (ii) may not be listed on the federal Food and Drug Administration list of drug products withdrawn or removed from the market for reasons of safety or effectiveness. ‘Then in USP-NF 795 it states 1 ‘Compounders shall first attempt to use components manufactured in an FDA-registered facility. When components can- not be obtained from an FDA-registered facility, compounders shall use their professional judgment in selecting an acceptable and reliable source and shall establish purity and safety by reasonable means, which should include Certificate of Analysis, manufacturer reputation, and reliability of source. There seems to be a contradiction here. In 795 | can use other sources and then c.i says i cannot. The facility | purchased from does not have FDA registration but provided a Certificate of Analysis and product was tested and meets USP standards for the chemical. Also the distribution model. The department of health was going to own the product and then it would be distributed out by them via independent pharmacies. This was stated as being illegal because that would be considered a 503b pharmacy. Below are parts of SB3002 hilpsJimail google comvmaitw0?ik=5469 16 78068 vew=pl&search=all&permmsgis=msg-Fk3h 1664082842266 184447&simpl-meg-%3AT6640828822.... 1/2 arso2020 State of Utah Mai - DOPL Qu (a)A health care provider is immune from civil liability for any_harm resulting from any_act or omission in the course of providing health care during a declared major public 3 health emergency if, 82 (i).(A) the health care is provided in good faith to treat a patient for the illness or 53 condition that resulted in the declared major public health emergency; _or 54 (B). io f providing health care to a patient for the 55 il it jjor public health emergency; and 56 {iy acts or orasions of the healt cae prover ware het oT (A)-grassly negligent, or 58 (8) intentional or malicious misconduct. 91 (4). (a) A person is immune from civil liability for providing assistance to an agency of 92 the state to manufacture, distribute, dispense, administer, or provide a qualified treatment 93 during a declared major public health emergency if the assistance is provided under contract 94 with and under the direction of the state agency. Mark, Does $B 3002 cover Meds In Motion? If not what needs to change in order to be ensured that there is. coverage? We have been working very closely with the state and have a very good plan. It would be a shame to have that plan foiled by a technicality. We appreciate your help during this unprecedented time in our state's history. We need to band together for the common good and get things turned back on. Thanks for your help Dan Richards Meds In Motion as Incmasin te meaane, osname con ceo hth erin, Te cine eco be wad xy yh lr rani ee ‘racreazo ita was ene nee passe ny Meds In Meer rman ten eszaeto th sr a Sst a ae anne ae ny rset Cas ethan prosody se mace Dl ane te at isrcn Potaay a essay Hee He ln plone ‘naps:fmall google. comma ?k=546916 18068 viow=pissearch=allépermmsgii=meg 3A 1664082882286 184447 &simpi=msq 3A 16540828822, 2 State of Uiah Mal - DOPL a Mark Steinagel DOPL Mark Steinagel Wed, Apr 15, 2020 at 5:26 PM To: "Richards, Dan , Evan Vickers , “val. peters ora Dan, 1 dont know anything about the case, but Iwill have my Chief Investigator take a Took att T wonder ifshe received a complaint Mark [Quoted texthiséen} Mark Steinagel Director Division of Occupational and Professional Licensing Utah Department of Commerce pl&searehalépermmegid=msg-a"%3Ar30323384884 1785 16308. meg SP4SAr30323984... 11 State of Utah Mai -DOPL, Mark Steinagel DOPL. Mark Steinagel Wed, Apr 15, 2020 at 5:35 PM To: "Richards, Dan" , Evan Vickers , "val_petersor RNa My chief investigator is looking into the matter right now. | informed my managers about the discussion on hydroxyehloroquine from a few weeks ago. Jennifer isa few levels down. I wonder If she somehow missed the message, We will help the Legislature and the Governor achieve your objectives, withthe help of the UDOH and the Coronavirus Task Fores, 1 think we can do it without modifying the statute, but let me know if you need to visit with me. Mark (On Wed, Apr 15, 2020 at 5:25 PM Richards, Dan wrote: [Quoted text nison} (Ouoted tox hier} Iitps:tmai google comimeilur07 16016 19008view=pl&soarch=allapermmsgid=meg.a%3AV87776416431 1596061Raimpl=meg-BIATGTITENIEA.. V1 3072020 Stale of Utah Mail- DOPL Issue L sae im a Cae he Mark Steinagel DOPL Issue Chris Parker Wed, Apr 15, 2020 al 6:19 PM Co rn MINIM ar scnsot

    You might also like