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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, March 31, 2020
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
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-
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 | 03/11/2020 | Pharmcore Inc. dba Hallandale Pharmacy | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| 03/31/2020 | 03/30/2020 | Bioactive C60/FullerLifeC60 LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | ||
| 03/31/2020 | 03/30/2020 | Halosense Inc. | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | ||
| 03/31/2020 | 03/30/2020 | JRB Enterprise Group Inc. DBA Anti Aging Bed | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/31/2020 | 03/25/2020 | Pfizer Healthcare India Private Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/31/2020 | 03/20/2020 | Bulletproof 360 Inc | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded |
03/31/2020 03/05/2020 Trilogy Laboratories, LLC Office of Pharmaceutical Quality Operations, Division II CGMP/Finished Pharmaceuticals/Adulterated
| 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
| 03/31/2020 | 02/28/2020 | FICOSOTA LTD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/31/2020 | 01/27/2020 | Cargill Incorporated | Division of Human and Animal Food Operations East III | CGMP/Medicated Feeds/Adulterated |
| 03/31/2020 | 01/14/2020 | Turkish Trade LLC d/b/a Tarblock, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 03/31/2020 | 01/14/2020 | TJD Holdings, Inc. d/b/a Venturi | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 03/31/2020 | 01/14/2020 | Soniceast LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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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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.
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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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.
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/
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.
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