FDA continues clampdown on compounders

FDA continues clampdown on compounders

BioPharma Dive-8 hours ago

Compounding can play an important role in treating certain groups of patients whose needs aren't met by existing products, like those allergic to certain ...

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA currently has a major operation underway to investigate and address this troubling finding. This investigation is led by a dedicated task force of experts focused solely on this important work. Their mandate is to oversee the investigation and track new developments and information coming in from valsartan manufacturers. This multidisciplinary team of chemists, toxicologists, medical doctors, pharmacists, investigators, communication specialists, and analytical lab staff coordinates across the FDA, and acts on the newest available information. Continue reading...

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

		The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Continue reading...

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas. Continue reading...

FDA IN BRIEF: FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernize drug development and promote innovation in drugs targeted to unmet needs

Today, the U.S. Food and Drug Administration announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. Complex innovative trial designs includes the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determiniations, and other novel designs. The new program is aimed at helping to solidify the science used to support these novel approaches, and promote their adoption in drug development programs where these trial constructs can advance innovation. Continue reading...

FDA Law Blog--

Facing Continuation of the Endo/Par Vasopressin Lawsuit, FDA Publishes Notice Concerning List of Drug Substances for Which there is [NOT?] a Clinical Need under Section 503B

Posted: 28 Aug 2018 08:05 AM PDT

By Karla L. Palmer —

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products Firm recalls hundreds of water-based products for humans and pets due to microbial contamination

The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately. 

Continue reading...

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

		The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers. Continue reading...

Texas Tightens Disclosure Rules Following Medicaid Investigation

NPR/Center for Public Integrity (August 17, 2018) Essley Whyte, Liz

California Board of Pharmacy Meeting Scheduled for September 7, 2018

September 7, 2018 Webcast

West Coast University – Classroom 372 590 North Vermont Ave. Los Angeles, CA 90004

Age Well, PHY 49116, Administrative Case AC 5972
Lompoc, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/2/2018.
View the decision

Animal Solutions Pharmacy, PHY 54438, Administrative Case AC 6068
Santa Rosa, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for four years subject to the terms and conditions in the decision.
Decision effective 7/10/2018.
View the decision

Apex Medical Distributors, WLS 3993, Administrative Case AC 5225
Valencia, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/2/2018.
View the decision

Central Rx Pharmacy, PHY 55855, Statement of Issues Case SI 6453
Brentwood, CA
Upon satisfaction of all statutory and regulatory requirements, the license is issued, immediately revoked and placed on probation for five years subject to the terms and conditions in the decision.
Decision effective 7/26/2018.
View the decision

Century Discount Pharmacy, PHY 39871, Administrative Case AC 5226
Reseda, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 7/10/2018.
View the decision

City Center Pharmacy, PHY 50457, Administrative Case AC 6456
Brentwood, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 7/26/2018.
View the decision

Florida Avenue Prescriptions, PHY 55943, Administrative Case AC 5748
Modesto, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for three years subject to the terms and conditions in the decision.
Decision effective 6/7/2018.
View the decision

Fusion Rx Compounding Pharmacy, PHY 49937, Administrative Case AC 5899
Los Angeles, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for four years subject to the terms and conditions in the decision.
Decision effective 7/2/2018.
View the decision

Golden Life Pharmacy, PHY 48911, Administrative Case AC 5773
Simi Valley, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for four years subject to the terms and conditions in the decision.
Decision effective 7/5/2018.
View the decision

Jonathan’s Pharmacy, PHY 50941, Administrative Case AC 5524
Apple Valley, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for five years subject to the terms and conditions in the decision.
Decision effective 6/7/2018.
View the decision

Pharmacy 9, PHY 40841, Administrative Case AC 6178
Santa Ana, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 6/28/2018.
View the decision

Pharmacy Resources, NRP 1126, Administrative Case AC 6021
Denver, CO
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/2/2018.
View the decision

Point Pharmacy, PHY 50655, Administrative Case AC 5858
Point Richmond, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/2/2018.
View the decision

Rosamond Pharmacy, PHY 46967, Administrative Case AC 5701
Rosamond, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/2/2018.
View the decision

Ross Medical Pharmacy, PHY 39267, Administrative Case AC 5852
La Crescenta, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 6/7/2018.
View the decision

Safeway Pharmacy #911, PHY 35032, Administrative Case AC 5957
San Rafael, CA
Through a disciplinary action of the Board, the license is publicly reproved.
Decision effective 6/7/2018.
View the decision

Sixth Avenue Pharmacy, PHY 46288, Administrative Case AC 5194
San Diego, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 8/2/2018.
View the decision

Thanhs Pharmacy, PHY 32480, Administrative Case AC 6193
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 8/2/2018.
View the decision

Trilogy Pharmacy Inc., NRP 1740, Administrative Case AC 6295
Dallas, TX
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 8/2/2018.
View the decision

Valencia Pharmacy, PHY 48891, Administrative Case AC
Valencia, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for five years subject to the terms and 1
Decision effective 6/7/2018.
View the decision

Walgreens Pharmacy #02126, PHY 52845, Administrative Case AC
San Carlos, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for two years subject to the terms and conditions in the decision.
Decision effective 6/7/2018.
View the decision

Warner West Pharmacy & Supplies, PHY 49208, Administrative Case AC 5866
Canoga Park, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 7/10/2018.
View the decision

Central Rx Pharmacy, PHY 55855, Administrative Case AC 6456
Brentwood, CA
Accusation Filed 6/6/2018; Case pending.
View the accusation

Central Rx Pharmacy, Applicant, Statement of Issues Case SI 6453
Brentwood, CA
Statement of Issues Filed 6/6/2018; Case pending.
View the accusation

City Center Pharmacy Brentwood Inc., PHY 50457, Administrative Case AC 6456
Brentwood, CA
Accusation Filed 6/6/2018; Case pending.
View the accusation

Rx Unlimited Pharmacy, PHY 50302, Administrative Case AC 6319
North Hills, CA
Accusation and Petition to Revoke Probation Filed 6/21/2018; Case pending.
View the accusation

Rx Unlimited Pharmacy, LSC 99642, Administrative Case AC 6319
North Hills, CA
Accusation and Petition to Revoke Probation Filed 6/21/2018; Case pending.
View the accusation

State Board Of Pharmacy Investigating Kaiser EpiPen Policy « CBS ...

https://sanfrancisco.cbslocal.com/.../state-board-of-pharmacy-investigating-kaiser-epip...

5 days ago - California State Board of Pharmacy officials are urging those affected by the policy to file a complaint. The organization has now opened an investigation into the ...

07/30/2018

Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy

San Francisco District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

08/16/2018

PharmaMedics

Center for Drug Evaluation and Research

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Not Issued

08/16/2018

MedInc.biz

Center for Drug Evaluation and Research

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Not Issued *

08/16/2018

PharmacyAffiliates.org

Center for Drug Evaluation and Research

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Not Issued *

07/31/2018

Hangzhou Karic Commodities Co., Ltd.

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

08/10/2018

Kyowa Hakko Bio Co., Ltd.

Center for Drug Evaluation and Research

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Not Issued *

08/15/2018

Healthy Healing dba Crystal Star

Minneapolis District Office

New Drug/Labeling/Misbranded

Not Issued *

The cure that pharmacies have been dreading

The Times-4 hours ago

Little more than a year after Amazon spooked grocers by acquiring Whole Foods, it did the same to pharmacists with its purchase of Pillpack, a mail-orde

John Arnold: Are pharmacy benefit managers the good guys or bad ...

STAT-18 hours ago

n the ongoing debate over drug prices, the pharmaceutical industry has been highly effective in shifting the blame to the middlemen — in particular to pharmacy ..

Fixing the opioid crisis requires the two things Congress hates most ...

NBCNews.com-13 hours ago

We are all now bearing the cost of our collective a

FDA Singles Out Three Drug Substances to Not be Compounded

Regulatory Focus-10 hours ago

Vasopressin, meanwhile, is the active ingredient in Vasostrict, and was the subject of Endo's lawsuit over how the FDA regulates drug compounding.

Par Wants Bulk Vasopressin Compounding Nixed; FDA Agrees
Law360-1 hour ago

FDA proposes restricting compounding of three drug substances
Reuters-10 hours ago

US FDA proposes restricting compounding of 3 drug substances
Thomson Reuters Foundation-10 hours ago

FDA Says No Need to Compound from Bumetanide, Nicardipine ...
Pharmaceutical Technology Magazine-7 hours ago

View all

Par Wants Bulk Vasopressin Compounding Nixed; FDA Agrees ...

https://www.law360.com/.../articles/.../fda-agrees-to-nix-compounding-of-vasopressin

1 hour ago - Just as Par Pharmaceutical asked a D.C. federal court Monday to enjoin a U.S. Food and Drug Administration policy governing bulk drug compounding, the

Texas Board of Pharmacy Disciplinary Action Summaries and Remedial Plans During August 7, 2018 Meeting

Disciplinary Action Summaries & Remedial Plans

Click here to view the disciplinary action summaries discussed and/or entered at the August 7, 2018 Board Meeting.

Click here to view the remedial plans discussed and/or entered at the August 7, 2018 Board Meeting.

Texas Board of Pharmacy Adopted and Proposed Rules at meeting on August 7, 2018

Several TSBP Board Rules were adopted and proposed during the Board Meeting on August 7, 2018. You may view a summary of the adopted and proposed rules here.

Draft Guidance Falls Short on Providing Clarity for Companies Denied Certificates to Foreign Government Posted: 26 Aug 2018 06:14 PM PDT By Allyson B. Mullen — One of the most painful consequences of a bad inspection at a U.S. facility is FDA’s resulting refusal to issue certificates to foreign governments (CFGs) until the issues are resolved. CFGs are quite often a requirement to renew licenses and permits to sell in various foreign markets. Although typically linked to a warning letter, sometimes a Form 483 can trigger this refusal. Sometimes it can take many months, or more than a year, for FDA to begin issuing CFGs again. During that time period, a manufacturer may find itself unable to sell product into certain foreign countries.

High Importance!! PHARMALOT Compounding licenses held by a major wholesaler are suspended in two states By ED SILVERMAN @Pharmalot AUGUST 27, 2018

Compounding licenses held by a major wholesaler are suspended in two states STAT AmerisourceBergen (ABC 1), which is one of the nation's largest pharmaceutical wholesalers, faces a fresh round of setbacks with its compounding .

US FDA proposes restricting compounding of three drug substances

US FDA proposes restricting compounding of three drug substances Nasdaq Aug 27 (Reuters) - The U.S. Food and Drug Administration on Monday in a first-of-its-kind action proposed restricting the ability of companies that ... US FDA proposes restricting compounding of 3 drug substances - Thomson Reuters Foundation FDA Singles Out Three Drug Substances to Not be Compounded - Regulatory Focus Full Coverage

FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs
	Today, the FDA issued a Federal Register notice proposing not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in compounding under section 503B of the Federal Food, Drug & Cosmetic Act (503B bulks list). Continue reading...

Prince's family file new wrongful death lawsuit

Iosco County News Herald-19 hours ago

... a doctor who provided Prince with care at the hospital, and an unidentified pharmacist or pharmacy employee "that consulted" in the care provided to Princ

Opioid Lawsuits Looking More Like A Tobacco Settlement Every Day

Forbes-17 hours ago

“Manufacturers, distributors, pharmacy benefit managers (PBM) and retailers are all vulnerable but credit implications will vary with the greatest cash flow effects ...

Pharmacist Pleads Guilty To Distributing Oxycodone In Exchange For ...

CBS Baltimore-4 hours ago

BALTIMORE (WJZ) — A licensed pharmacist, Richard Daniel Hiller, 64, of Owings Mills, Md., pleaded guilty Friday to conspiracy to distributing oxycodone, and ...

Towson pharmacist pleads guilty to giving out painkillers in exchange ...
Fox Baltimore-3 hours ago

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FDA to Ban More Supplements? - Health Impact News

https://healthimpactnews.com/2018/fda-to-ban-more-supplements/

22 hours ago - The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made .

• Pharmacy Compounding Advisory Committee Charter (updated)

• Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding (updated)

FDA Plan to Combat Fraud by Compounders Would Boost Patient Safety The Pew Charitable Trusts · 7 hours ago

FDA Plan to Combat Fraud by Compounders Would Boost Patient Safety

The Pew Charitable Trusts · 7 hours ago

FDA Awards Contract to Develop Opioid Use Guidelines

Pharmacy Practice News-10 hours ago

By Marie Rosenthal. With more than 40 people a day dying from an opioid overdose, the epidemic of opioid abuse in the United States is taking a staggering ...