Tuesday, March 31, 2020

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

“The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible,” said HHS Secretary Alex Azar. “As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to...
7 days ago - ... patients, supplying a compounded formulation with hydroxychloroquine. ... The state of Utah wants to slow down panic buying of two drugs that some health ..
5 days ago - The FDA said it won't object to outsourcing facilities using hydroxychloroquine sulfate or chloroquine phosphate for compounding during the COVID-19
4 days ago - Alerts. SIG Alert: Update On Efforts to Allow the Compounding of Hand Sanitizer Mar 24, 2020 - Members Only; SIG Alert: Compounding SIG Participation Survey 
6 days ago - This does not reflect the Compounding Expert Committee's opinions on future development or revisions to official text of the. USP-NF. USP is actively monitoring ...
16 hours ago - South Shore Health's pharmacy team works to make homemade hand sanitizer ... an order allowing Massachusetts pharmacies and pharmacists to compound .
19 hours ago - US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand. Pharmacies ... Side view of titration in a compounding pharmacy ...
58 mins ago - Innovative Rx Compounding Pharmacy stated in a press release that they are working with multiple vendors to meet a growing need for products in the Tri-Cities 

Tucson pharmacy fights coronavirus by making hand sanitizer ...

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16 hours ago - Compounding pharmacies mix drugs from existing approved compounds and make special drugs prescribed by doctors in dosages or forms that are not generally ..

03/31/2020 03/05/2020 Trilogy Laboratories, LLC Office of Pharmaceutical Quality Operations, Division II CGMP/Finished Pharmaceuticals/Adulterated

03/31/2020 02/28/2020 FICOSOTA LTD Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated

Combating the Opioid Epidemic with the False Claims Act

Combating the Opioid Epidemic with the False Claims Act
The DOJ is getting more creative.
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Supreme Court to Hear PBM state regulation challenge

The U.S. Supreme Court has agreed to hear oral argument in a case related to state regulation of Pharmacy Benefit Managers (PBM) rates.
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Trump calls for shutdown until April 30



President Donald Trump is extending the voluntary national shutdown for a month as sickness and death from the coronavirus pandemic rise in the U.S.
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HHS wants hospitals with in-house labs to report COVID-19 results daily



Vice President Mike Pence wrote hospitals saying that in-house labs are not tracked the same as private labs. The data is needed to get a complete picutre of the COVID-19 outbreak.
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Trump's flipped his view on pharma companies thanks to COVID-19. Will the public?

Trump's flipped his view on pharma companies thanks to COVID-19. Will the public?

J&J, BARDA commit $1B to COVID-19 vaccine R&D

J&J, BARDA commit $1B to COVID-19 vaccine R&D

Monday, March 30, 2020
Johnson & Johnson has joined with a U.S. government agency to commit $1 billion to development of a COVID-19 vaccine. 

Abbott to ship portable, 5-minute coronavirus tests nationwide

Abbott to ship portable, 5-minute coronavirus tests nationwide

Without data, but with Trump praise, FDA issues emergency nod for chloroquine in COVID-19

Without data, but with Trump praise, FDA issues emergency nod for chloroquine in COVID-19

Pentagon to Modify Hundreds of Contracts for COVID-19 Response // Frank Konkel

Pentagon to Modify Hundreds of Contracts for COVID-19 Response
// Frank Konkel
The Defense Department is ramping up the purchase of certain items, including ventilators, in response to the COVID-19 outbreak.

'Red Dawn Breaking Bad': Officials warned about safety gear shortfall early on, emails show


A high-ranking federal official in late February warned that the United States needed to plan for not having enough personal protective equipment for medical workers as they began to battle the novel coronavirus, according to internal emails obtained by Kaiser Health News.
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Limited testing poses challenges to mapping COVID-19 spread



Researchers and companies are trying new approaches to map the novel coronavirus' spread. It's a challenge, given the limited number of tests available to confirm where cases actually are.
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CMS eases requirements for transferring non-COVID-19 infected patients

In a host of regulatory relief measures, the CMS made it easier for hospitals to create more capacity to address the coronavirus pandemic.
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Chinese APIs flowing but India ban hinders U.S. approval of hydroxychloroquine

Chinese APIs flowing but India ban hinders U.S. approval of hydroxychloroquine

Coronavirus tracker: CEO says J&J won't profit from COVID-19 shot; China amps up ventilator production

Coronavirus tracker: CEO says J&J won't profit from COVID-19 shot; China amps up ventilator production

Friday, March 27, 2020

Texas Board of Pharmacy Upcoming Meeting May 5, 2020 and now live streaming meetings

Upcoming Board Meeting - May 5, 2020


The next Texas State Board of Pharmacy Board Meeting will be held in May. TSBP Board Meetings are open to the public, and interested parties are encouraged to attend. Pharmacists and pharmacy technicians who attend the full-day meeting in person may be awarded three CE hours. Signing in and out at the meeting will be required for CE credit.

Details of the upcoming meeting are as follows:

Date: May 5, 2020
Time: 9:00 a.m. – Conclusion
Location***: William P. Hobby, Jr. Building, 333 Guadalupe Street, Suite 2-225, Austin, Texas 78701
Materials: Posted here when available
Visitor Information: The Hobby Building entrance is at the corner of 4th Street and Guadalupe Street. All visitors must check in at the Security Desk and be issued a visitor’s badge. Visitors are encouraged to arrive early to accommodate parking and check-in processes.

Live Stream Information: The Board is now live streaming meetings. See this page for details.

***PLEASE NOTE: The meeting location is subject to change if a state of disaster and/or concerns about coronavirus are still in effect. TSBP will notify constituents as soon as possible if meeting details are changed. Notice will be posted on the TSBP website, social media, and via newsletter if applicable. If the meeting is held remotely, CE credit will not be awarded.

Texas Board of Pharmacy Suspension of Certain Rule Requirements

Temporary Suspension of Certain Rule Requirements


In addition to the adoption of 291.30, the Office of the Governor temporarily suspended several rules. We've included summaries below.

For more detailed information and potential updates, visit us at www.pharmacy.texas.gov/coronavirus.

 
Temporary Suspension of Certain Rule Requirements - Issued March 20, 2020
§291.17 – The Office of the Governor has temporarily suspended the annual inventory notarization requirement in §291.17(c)(3).
§291.33 – The Office of the Governor has temporarily suspended the requirement in §291.33(c)(1)(B)(iii) to have in-person contact for patient counseling in order to allow patient counseling to be performed by telephonic consultation.
§291.36 – The Office of the Governor has temporarily suspended the requirement in §291.36(2) to obtain to obtain an inspection within the last renewal period in order to renew a Class A-S pharmacy license.
§291.54 – The Office of the Governor has temporarily suspended the requirement in §291.54(a)(13) to obtain an inspection within the last renewal period in order to renew a Class B pharmacy license.
§291.77 – The Office of the Governor has temporarily suspended the requirement in §291.77(2) to obtain an inspection within the last renewal period in order to renew a Class C-S pharmacy license.
§291.106 – The Office of the Governor has temporarily suspended the requirement in §291.106(4) to obtain an inspection within the last renewal period in order to renew a Class E-S pharmacy license.
§291.121 – The Office of the Governor has temporarily suspended the requirement in §291.121(d)(3), (4)(C)(i) to the extent necessary to expand the pilot program for automated systems in order to allow for remote automated dispensing.
§295.15 – The Office of the Governor has temporarily suspended the requirement in §295.15(c)(2)(C) to maintain documentation of current certification in American Heart Association's Basic Cardiac Life Support for Health-Care Providers or its equivalent in order to provide immunization or vaccination under written protocol of a physician.