Wednesday, February 19, 2020

Ducey's Pharmacy Board Flip-Flops on Bill Giving Prescription Info to Insurers STEVEN HSIEH | FEBRUARY 18, 2020 | 10:58AM

https://www.phoenixnewtimes.com/news/arizona-bill-brophy-mcgee-pharmacy-insurers-prescription-info-ducey-11443868

The 20 most expensive pharmacy drugs in the U.S. in 2020, from fallen blockbusters to new orphan meds by Eric Sagonowsky | Feb 14, 2020 9:45am

https://www.fiercepharma.com/pharma/20-most-expensive-pharmacy-drugs-u-s-2020

CVS subpoenaed by U.S. over pharmacies’ role in opioid crisis

https://www.southcoasttoday.com/news/20200218/cvs-subpoenaed-by-us-over-pharmacies-role-in-opioid-crisis

Air Force Pharmacy In Maryland Left Patient Labels On Reused Prescriptions Victoria Chamberlin

https://wamu.org/story/20/02/14/air-force-pharmacy-in-maryland-left-patient-labels-on-reused-prescriptions/

Pharmacy provider alerts 1,200 patients of phishing attack Mackenzie Garrity - 7 hours ag

https://www.beckershospitalreview.com/cybersecurity/pharmacy-provider-alerts-1-200-patients-of-phishing-attack.html

OIG Finds Serious Misuse of Medicare Data Transactions by Pharmacies A recent OIG audit of mail-order pharmacy’s Medicare Part D E1 transactions found rampant improper access and misuse of Medicare beneficiary data by pharmacies.

https://healthitsecurity.com/news/oig-finds-serious-misuse-of-medicare-data-transactions-by-pharmacies

Opinion LETTERS When Pharmacists Make Drug Errors The American Pharmacists Association says we need to look at how pharmacies are reimbursed and who profits. Also: The folly of environmental deregulation; the poor and the cashless society.

https://www.nytimes.com/2020/02/17/opinion/letters/pharmacists-errors.html

DEA Raids Montecito’s San Ysidro Pharmacy as Part of Federal Investigation The state Board of Pharmacy does have a pending accusation against the pharmacist in charge, but it's unclear whether it's related

https://www.noozhawk.com/article/dea_raids_montecito_san_ysidro_pharmacy_federal_investigation_20200213

‘Buy American’ Drug Decision Opens Door to Foreign Supplies Feb. 18, 2020, 3:55 AM

https://news.bloomberglaw.com/us-law-week/buy-american-drug-decision-opens-door-to-foreign-supplies

A Bipartisan Senate Drug Pricing Bill Even Got Trump’s Thumbs Up. So Why Is It On Life Support?

https://khn.org/morning-breakout/a-bipartisan-senate-drug-pricing-bill-even-got-trumps-thumbs-up-so-why-is-it-on-life-support/

US, India stopped 500 shipments of illicit prescription drugs from entering America in January Read more at: https://www.deccanherald.com/international/world-news-politics/us-india-stopped-500-shipments-of-illicit-prescription-drugs-from-entering-america-in-january-805996.html

Top 10 medication errors and hazards, according to medication safety group John Murphy, MDLinx | February 19, 2020

https://www.mdlinx.com/internal-medicine/article/6140

'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost 19-Feb-2020 By Nick Taylor

'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost

 By Nick Taylor
President Trump proposes extra cash for US FDA to address “significant problems at many inspected outsourcing facilities.”

FDA Releases Revised Draft Guidance on Compounding ..

5 days ago - Animal drug compounding is generally a practice in which a state-licensed pharmacist or state-licensed veterinarian combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient

California Board of Pharmacy Accusations Filed November-December 2019

All Meds Solution Inc., PHY 54464, Administrative Case AC 6860
Los Angeles, CA
Accusation Filed 12/30/2019; Case pending.
AMC Pharmacy, PHY 45993, Administrative Case AC 6708
Burbank, CA
Accusation Filed 12/12/2019; Case pending.
Anchor Drugs III, PHY 48787, Administrative Case AC 6819
S. San Francisco, CA
Accusation Filed 12/10/2019; Case pending.
Colorado Pharmacy, PHY 52413, Administrative Case AC 6562
Los Angeles, CA
First Amended Accusation Filed 12/10/2019; Case pending.
Highland Hospital Pharmacy, HPE 14210, Administrative Case AC 6755
Oakland, CA
Accusation Filed 12/12/2019; Case pending.
Innovative Compounding Pharmacy, PHY 48417, Administrative Case AC 6683
Folsom, CA
Accusation and Petition to Revoke Probation Filed 12/3/2019; Case pending.
Innovative Compounding Pharmacy, LSC 99600, Administrative Case AC 6683
Folsom, CA
Accusation and Petition to Revoke Probation Filed 12/3/2019; Case pending.
Luke’s Yreka Drug, PHY 50715, Administrative Case AC 6732
Yreka, CA
Accusation Filed 12/2/2019; Case pending.
March Lane Medical Pharmacy, PHY 46401, Administrative Case AC 6782
Stockton, CA
Accusation Filed 12/2/2019; Case pending.
McKesson Drug Company, WLS 3076, Administrative Case AC 6850
Santa Fe Springs, CA
Accusation Filed 12/10/2019; Case pending.
Noice Rx, Applicant, Statement of Issues Case SI 6797
Irvine, CA
Statement of Issues Filed 12/12/2019; Case pending.
View Accusation
Ojai Valley Community Hospital, HSP 47202, Administrative Case AC 6517
Ojai, CA
Accusation Filed 12/12/2019; Case pending.
PCH Medical Pharmacy, PHY 44527, Administrative Case AC 6826
Long Beach, CA
Accusation Filed 12/2/2019; Case pending.
Rx unlimited Pharmacy, PHY 50302, Administrative Case AC 6319
North Hills, CA
Second Amended Accusation and Petition to Revoke Probation Filed 12/2/2019; Case pending.
Rx unlimited Pharmacy, LSC 99642, Administrative Case AC 6319
North Hills, CA
Second Amended Accusation and Petition to Revoke Probation Filed 12/2/2019; Case pending.
Santa Maria Community Pharmacy, PHY 50309, Administrative Case AC 6171
El Monte, CA
Second Amended Accusation Filed 12/4/2019; Case pending.
 Angkor Pharmacy, PHY 53262, Administrative Case AC 6698
Stockton, CA
Accusation Filed 11/15/2019; Case pending.
Balboa Pharmacy, PHY 51136, Administrative Case AC 6514
Granada Hills, CA
Accusation Filed 11/14/2019; Case pending.
Bruce Pharmacy, PHY 55523, Administrative Case AC 6698
Stockton, CA
Accusation Filed 11/15/2019; Case pending.
Central Care Pharmacy, PHY 47333, Administrative Case AC 6780
Encino, CA
Accusation Filed 11/7/2019; Case pending.
CVS Pharmacy #9708, PHY 47872, Administrative Case AC 6759
Pomona, CA
Accusation Filed 11/13/2019; Case pending.
Senior Care Pharmacy Services Inc., PHY 49798, Administrative Case AC 6417
Sun Valley, CA
Accusation Filed 11/21/2019; Case pending.
Senior Care Pharmacy Services SFV Inc., PHY 56057, Administrative Case AC 6417
Sun Valley, CA
Accusation Filed 11/21/2019; Case pending.
Senior Care Pharmacy Services SFV Inc., Applicant, Statement of Issues Case SI 6614
Sun Valley, CA
Statement of Issues Filed 11/21/2019; Case pending.
View the Accusation
Star Pharmacy, PHY 48401, Administrative Case AC 6555
Van Nuys, CA
Accusation Filed 11/4/2019; Case pending.
Star Pharmacy, PHY 57459, Administrative Case AC 6555
Van Nuys, CA
Accusation Filed 11/4/2019; Case pending.
The Medicine Shoppe, PHY 51652, Administrative Case AC 6669
Tarzana, CA
Accusation Filed 11/15/2019; Case pending.
West Marin Pharmacy Inc., PHY 48531, Administrative Case AC 6801
Point Reyes Station, CA
Accusation Filed 11/14/2019; Case pending.

California Board of Pharmacy Disciplinary Action: October 1, 2019-December 21, 2019

Facility Licenses
Alameda Pharmacy LLC and Artomus LLC dba Alameda Pharmacy LLC, PHY 52059, Administrative Case AC 6365
San Leandro, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 10/10/2019.
Cardinal Health, dba Parmed Pharmaceuticals, LLC, OSD 4895, Administrative Case AC 6329
Niagara Falls, NY
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 09/26/2019.
Columbia Excel Pharmacy, PHY 44884, Administrative Case AC 6552
West Hills, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 11/14/2019.
Coyote Valley Pharmacy, PHY 50618, Administrative Case AC 6314
Hidden Valley Lake, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The effective date shall be stayed 180 days from the effective date of the decision and order, at which time the pharmacy shall be sold or closed.
Decision effective 11/14/2019.
CSL Capitol Holdings LLC dba New Life Pharmacy LLC, NRP 1465, Administrative Case AC 6365
Sandy, UT
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 10/10/2019.
CVS Pharmacy #9566, PHY 47789, Administrative Case AC 6576
Long Beach, CA 
Through a disciplinary action of the Board, the license is publicly reproved. 
Decision effective 11/27/2019.
Drogueria De La Villa Inc., OSD 5317, Administrative Case AC 5552
Ponce, Puerto Rico
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 11/27/2019.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, PHY 53726, Administrative Case AC 6371
Los Angeles, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 10/25/2019
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, LSC 100855, Administrative Case AC 6371
Los Angeles, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 10/25/2019
Kaiser Permanente Pharmacy #249, PHY 49886, Administrative Case AC 6317
San Diego, CA
Through a disciplinary action of the Board, the license is publicly reproved.
Decision effective 10/10/2019.
Kelseyville Pharmacy, PHY 46140, Administrative Case AC 6314
Kelseyville, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The effective date shall be stayed 180 days from the effective date of the decision and order, at which time the pharmacy shall be sold or closed.
Decision effective 11/14/2019.
Partner Healthcare, Inc. PHY 51078, Administrative Case AC 6176
Monrovia, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the license is placed on probation for five years subject to the terms and conditions in the decision.
Decision effective 12/03/2019.
Prima Pharmacy, PHY 51571, Administrative Case AC 6434
North Hollywood, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the license is placed on probation for three years subject to the terms and conditions in the decision.
Decision effective 11/27/2019.
Procare Pharmacy, PHY 46937, Administrative Case AC 6251
Murrieta, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the license is placed on probation for five years subject to the terms and conditions in the decision.
Decision effective 11/27/2019.
R & O Pharmacy, PHY 51259, Administrative Case AC 6010
Camarillo, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 09/26/2019.
RX Ingredients, Inc., PHY 48315, Administrative Case AC 6215
Van Nuys, CA 
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 11/27/2019.
Stanford Health Care, HSP 44847, Administrative Case AC 6631
Stanford, CA
Through a disciplinary action of the Board, the license is publicly reproved.
Decision effective 11/14/2019.
Stanford Health Care, LSC 100453, Administrative Case AC 6631
Stanford, CA
Through a disciplinary action of the Board, the license is publicly reproved.
Decision effective 11/14/2019.
Sutter Pharmacy, PHY 47489, Administrative Case AC 6177
Yuba City, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The effective date shall be stayed 90 days from the effective date of the decision and order, at which time the pharmacy shall be sold or closed.
Decision effective 11/14/2019.
Valor Compounding Pharmacy, PHY 56799, Administrative Case AC 6433
Berkeley, CA
Through a disciplinary action of the Board, the license is publicly reproved.
Decision effective 11/14/2019.
Vitacare Pharmacy, PHY 51535, Administrative Case AC 6311
Oakland, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/3/2019.
Wellspring Compounding Pharmacy, PHY 54419, Administrative Case AC 6433
Berkeley, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 11/14/2019.

California Board of Pharmacy Meeting 1/29/20-1/30/20

January 29-30, 2020Embassy Suites by Hilton Los Angeles-Glendale
800 North Central Ave.
Glendale, CA 91203
1/29/20-1/30/20
Agenda
1/29/20-1/30/20
Meeting Materials

1/29/20-1/30/20
Additional Materials
1/29/20-1/30/20
Action Items
1/29/20
Webcast
1/30/20
Webcast

California Board of Pharmacy: Compounding Requirements Pending USP Appeals – 11/7/19

Compounding Requirements Pending USP Appeals – 11/7/19

California Board of Pharmacy: New Pharmacy Laws for 2020

New Pharmacy Laws for 2020 (PDF)

Friday, February 14, 2020

FDA Provides Additional Time for Stakeholders to Comment on Revised Draft Guidance on Animal Drug Compounding from Bulk Drug Substances


In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.

The new deadline to receive comments will be June 17, 2020.

The Federal Register Notice for the reopening of the comment period is forthcoming. A link will be provided on or shortly after February 20, 2020.

FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad


The following is attributed to Stephen M. Hahn, M.D, FDA Commissioner
The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers. 

Active Supply Chain Surveillance
We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages. The FDA has...

FDA Cautions Pet Owners Not to Feed One Lot of Aunt Jeni’s Home Made Frozen Raw Pet Food Due to Salmonella




Fast Facts

  • The U.S. Food and Drug Administration is cautioning pet owners not to feed their pets one lot of Aunt Jeni’s Home Made frozen raw pet food after a sample collected from a store in the District of Columbia tested positive for Salmonella.
  • The product is Aunt Jeni’s Home Made All-Natural Raw Turkey Dinner Dog Food, 5 lb. (2.3 kg), lot 175331 NOV2020.
  • If you have any of the affected Aunt Jeni’s Home Made product, stop feeding it to your pet, throw it away, and sanitize surfaces that may have come in contact with the product.
  • FDA is issuing this alert because this lot of Aunt Jeni’s Home Made frozen raw pet food represents a serious threat to human and animal health. Because the product is sold and stored frozen, FDA is concerned that people may still have it in their possession.
  • Salmonella can affect both human and animal health. People with symptoms of Salmonella infection should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella infection.

D.C. Circuit nixes Arkansas Medicaid work requirement


The ruling is a major blow to the Trump administration's Medicaid policy centerpiece of requiring beneficiaries to work as a condition of receiving benefits.
READ MORE >

Animal Health International Inc. Pleads Guilty to Introduction of Misbranded Drugs into Interstate Commerce Animal Health International Will Pay More Than $52 Million in Forfeitures, Fines, and Penalties

Animal Health International Inc. Pleads Guilty to Introduction of Misbranded Drugs into Interstate Commerce
Animal Health International Will Pay More Than $52 Million in Forfeitures, Fines, and Penalties

Abingdon, VIRGINIA – Animal Health International Inc. (AHI), a Colorado corporation that obtains prescription drugs for animals from manufacturers for further distribution to veterinarians, farms, feedlots, and other facilities, pleaded guilty today, through its corporate counsel, in U.S. District Court to introducing a misbranded drug into interstate commerce. Also, Patterson Companies, Inc. (Patterson) AHI’s corporate parent, entered into a non-prosecution agreement in which it committed to enhance its compliance program and fully comply with the law. United States Attorney Thomas T. Cullen and Special Agent in Charge Mark S. McCormack of the FDA’s Office of Criminal Investigations Metro Washington Field Office, made the announcement today.

FDA In Brief: FDA Seeks Input from the Public to Help Prevent Future Lung Injuries Associated with Vaping

The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.: 
“Since last year, the Food and Drug Administration, the Centers for Disease Control and Prevention and state health authorities have diligently worked to identify substances of concern and characterize the outbreak of lung injuries associated with vaping products.

“We remain deeply concerned about these injuries and deaths and continue to work with other agencies, as well as state and local public health officials, on this complex investigation. National and state data from patient reports and product sample testing suggest vaping products containing tetrahydrocannabinol, particularly from informal sources like friends, or family, or in-person or online dealers, are linked to most cases and play a major role, and that the presence of the compound vitamin E acetate in vaping products is strongly linked to the outbreak. 

“Our investigation has brought to the forefront the serious risks of using illicit, black market products. As part of our efforts to mitigate and prevent a potential future outbreak of vaping injuries, we are asking the public for input on additional steps the FDA can take to inform our regulatory work and address the illegal modification of these products.”

Tuesday, February 11, 2020