| 01/11/2018 | Healthy Healing dba Crystal Star | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
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
Thursday, January 25, 2018
| 01/11/2018 | Soothedrawal, Inc. | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Wong Lap Kwong Medicine Company Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 01/11/2018 | Guna Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/12/2018 | Beauty Manufacturing Solutions Corp. | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
National pharmacy company with office in Buffalo reports data breach
Pharmacy Today, American Pharmacists Association, pharmacist.com-14 hours ago
Onco360 and CareMed Specialty Pharmacy, which are subsidiaries of PharMerica, have reported a data breach. A company statement said that suspicious activity was noticed in November 2017, when an unauthorized user obtained access to three employee emails. Affected information could include patient and medical ...
Judge Tosses Lawsuit Alleging Nondisclosure of Rift Between ...
Law.com-8 hours ago
A federal judge in New York on Tuesday dismissed a derivative lawsuit that accused directors of the country's largest pharmacy benefits manager of hiding from investors its troubled relationship with health insurance giant Anthem Inc. In a 19-page unpublished opinion, U.S. District Judge Edgardo Ramos of the Southern .
$1.5M drug fraud a prescription for prison for pharmacy manager ...
NJ.com-10 hours ago
A 34-year-old operations manager for a specialty pharmacy in Union City forged documents and submitted $1.5 million in false bills to Medicare and Medicaid as well as private insurers, authorities said. Ruben Sevumyants, of Marlboro, was charged Wednesday with conspiracy to commit health care fraud, the U.S. ...
Prince George's County is suing opioid manufacturers
The Diamondback-22 hours ago
The drugs have been overprescribed, which has compounded the crisis, Baker added. He said the county is seeking monetary damages to ... McDonough said county jails have seen upticks in drug use, addiction and people requesting placement into drugtreatment programs. She said some inmates go through withdrawal ...
New Bulk Substance Compounding Guidance Coming In 2018 ...
10 hours ago - In the wake of a controversial policy that ended up getting the agency sued, FDA announced it will release new guidance in March on determining the clinical need to warrantcompounding using bulk substances, which one source familiar with the drafting and negotiations around the compounding law says could “right the ...
Diamondback Drugs Now a Recommended Veterinary Pharmacy of The Veterinary Cooperative
National veterinary compoundingpharmacy Diamondback Drugs is excited to announce their recent partnership with The Veterinary Cooperative (TVC). As a recommended vendor within TVC's supplier formulary, Arizona-based Diamondback Drugs will be supporting
A weak link in the medical chain exposed: Drug compounding
Drug compounding is a serious issue. Defined by FDA as a process that “combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient,” compounding plays an important role
Wednesday, January 24, 2018
Senate confirms Azar as HHS secretary
The Senate confirmed Alex Azar as HHS secretary Wednesday, filling a months-long vacancy. Azar is expected to reshape the ACA exchanges which face uncertain futures as a result of executive and legislative efforts to dismantle them. READ MORE
Warning to patients after pharmacy license of Clinical Apothecaries in Medina suspended
POSTED 3:04 PM, JANUARY 19, 2018, BY KARA SUTYAK AND KEVIN FREEMAN, UPDATED AT 03:52PM, JANUARY 19, 2018
DAILY NEWS
E&C Health Panel To Hold Compounding Hearing Jan. 30, Gottlieb To Testify
January 23, 2018
The House Energy & Commerce health subcommittee will hold a hearing on implementation of the compounding law, the Drug Quality and Security Act, Tuesday (Jan. 30), three sources tell Inside Health Policy . FDA Commissioner Scott Gottlieb is set to testify, as will a variety of compounding stakeholders. As IHP first reported late last year , stakeholders had been expecting E&C to hold a compounding hearing in January. While the International Academy of Compounding Pharmacists previously said the...
Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting as congressional Republicans take another run at repealing Obamacare.
Must Read! High Importance! From the FDA Law Blog
|
Posted: 23 Jan 2018 08:07 PM PST
By Karla L. Palmer —
As stated in our blogpost discussing |
Tuesday, January 23, 2018
FDA Adds New Compounding Pharmacy Regulations
In an effort to clarify existing rules and regulations—and create new ones—the FDA has announced its plans and priorities for compounding pharmacy in 2018. Scott Gottlieb, MD, FDA Commissioner says that “because
Monday, January 22, 2018
Two Dietary Supplements Recalled for Possible Salmonella ...
Food Poisoning Bulletin-10 hours ago
Two dietary supplements: Break Ventures “Zero For Him” and “Arthri-D” are being recalled for possible Salmonella contamination. No illnesses have been reported to date in connection with this issue. Zero for Him is a supplement that is distributed nationwide through Amazon. The product has 150 capsules in a 400 cc ...
Doping - Sports tribunal begins hearing appeals from 39 banned ...
Channel NewsAsia-11 hours ago
GENEVA: The Court of Arbitration for Sport (CAS) began to hear appeals on Monday from 39 Russian athletes who were given lifetime Olympic bans for doping violations at the 2014 Sochi Games. The athletes were among 43 disqualified from their events, banned from participating in future Olympics and in some cases ...
Appeal begins in Geneva for Russian athletes suspended in doping ...
The Local Switzerland-12 hours ago
The Local Switzerland-12 hours ago
Colorado legislature to take up pharmacy choice bill
Pharmacy Today, American Pharmacists Association, pharmacist.com-10 hours ago
A measure introduced in the Colorado General Assembly would allow patients to go to whichever pharmacy they choose. The Patient Choice of Pharmacy measure is primarily geared toward patient choice and protecting small, rural pharmacies that may be closer to patients than pharmacies selected by health insurance ...
FDA policy wades into battles between drug makers and compounders
mid rising tension between drug makers and compound pharmacies, the Food and Drug Administration has issued new policies 1 that seek to bolster manufacturing standards for compounded medicines and, in the process, may serve to establish competitive boundaries between
Top Organizations Urge a Concerted Effort To Improve Safety in Hospital Compounding
WASHINGTON, Jan. 22, 2018 /PRNewswire/ -- Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was
Saturday, January 20, 2018
Man enters Alford plea in Eastern Panhandle pill mill case
Herald-Mail Media-18 hours ago
The pharmacy, which has since closed, was at the center of the state's pill mill case against pharmacist David Wasanyi, who was convicted of 13 counts of delivery of a controlled substance in October 2016 and subsequently sentenced in in Berkeley County Circuit Court to serve five to 75 years in prison. A similar case filed ...
53000 patient records breached after phishing hack on Onco360 ...
Healthcare Finance News-21 hours ago
A hacker breached employee email accounts of Onco360 and CareMed Specialty Pharmacy, exposing the data of 53,173 patients, according to Onco360. Officials discovered suspicious activity on an employee's email account in November. The oncology pharmacy company contracted an outside forensic team to ...
Warning to patients after pharmacy license of Clinical Apothecaries ...
fox8.com-Jan 19, 2018
"Let's say you're allergic to an ingredient in a commercially available drug, so a compounding pharmacy would make a drug, in accordance with a doctor's order, that removes that allergen or that product that you're allergic too," said McNamee. The board is strongly recommending patients immediately stop using all of their ..
Mixing, Diluting, or Repackaging Biological Products Outside - FDA
13 hours ago - Scope of an Approved. Biologics License. Application. Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). January 2018.Compounding and Related Documents ...
Friday, January 19, 2018
Lawmakers want to give pharmacists the ability to test for flu
NBC2 News-3 hours ago
Lee Health is reporting quadruple the amount of flu cases this year than this time last year. Dozens of people across the country have died from the flu, and Florida is no exception. Florida lawmakers want to fight the flu by giving pharmacists the ability to test for the illness, taking some of the burden off of doctors.
Lawmakers want to give pharmacists the ability to test for flu
NBC2 News-3 hours ago
Lee Health is reporting quadruple the amount of flu cases this year than this time last year. Dozens of people across the country have died from the flu, and Florida is no exception. Florida lawmakers want to fight the flu by giving pharmacists the ability to test for the illness, taking some of the burden off of doctors.
Thursday, January 18, 2018
Lawmakers want to give pharmacists the ability to test for flu
NBC2 News-3 hours ago
Lee Health is reporting quadruple the amount of flu cases this year than this time last year. Dozens of people across the country have died from the flu, and Florida is no exception. Florida lawmakers want to fight the flu by giving pharmacists the ability to test for the illness, taking some of the burden off of doctors.
Pharmacists Rank Among 100 Best, Highest Paying Jobs of 2018
Pharmacy Times-8 hours ago
US News & World Report recently released its ranking of the highest paying and best overall jobs of 2018, and pharmacists made the cut for both lists. ... In terms of job satisfaction, pharmacy was given an “above average” rating for upward mobility, “above average” rating for stress level, and “below average” rating for
Medina pharmacy's license suspended due to mishandling of drugs ...
cleveland.com-1 hour ago
The eight-page letter alleges Potter refused to stop dispensing sterile compounds after the pharmacy was issued a notice from the board following an inspection report that required the pharmacy to stop "compounding until records can be produced or complete testing." The notice was issued on Jan. 5. Potter signed it but ...
Health system-led drug company unlikely to make a dent in drug ...
ModernHealthcare.com-5 hours ago
Scott Knoer, Cleveland Clinic's chief pharmacy officer, said he is interested in learning more to see about the viability of partnering in the new generic drug company or re-creating the model. The Cleveland Clinic also plans to expand its compoundingfacility to create IV products and other drugs in large batches as a reserve ...
2018 Compounding Policy Priorities Plan
FDA.gov-7 hours ago
"Pharmacy compounding continues to play an important role in helping patients and providers advance public health. But these practices must adhere to the modern rules that Congress recently enacted, including in the Drug Quality and Security Act, to enhance the safety and sterility of these medicines. The FDA is fully ...
meningitis-etc: Nine Still Face Trial in NECC Case
meningitis-etc: Nine Still Face Trial in NECC Case: By Walter F. Roche Jr. Though it has been more than five years since a deadly fungal meningitis sickened 778 patients across the country ...
meningitis-etc: $611,774 Forfeiture Order Sought on Chin.
meningitis-etc: $611,774 Forfeiture Order Sought on Chin.: By Walter F. Roche Jr. Federal prosecutors are asking a judge to issue a $611,774 forfeiture order against, Glenn Chin, the pharmacist co...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls
| |||
Wednesday, January 17, 2018
Texas Workers' Comp Division Seeks Comments on Compounded Drugs
Texas Workers' Comp Division Seeks Comments on Compounded ...
Insurance Journal-Jan 16, 2018
On June 16, 2017, DWC announced an informal draft rule to require that compounded drugs be preauthorized. The rule was drafted at the request of the legislature after a DWC study found that the cost of compounded drugs doubled from 2010-2014, and the average cost per prescription had risen to $829 in 2016.
Imprimis receives FDA warning over eye medication advertising
Imprimis receives FDA warning over eye medication advertising
Reuters-19 hours ago
Jan 16 (Reuters) - The U.S. Food and Drug Administration has issued a warning letter to Imprimis Pharmaceuticals Inc accusing it of making false or misleading claims that its compounded eye medications had the agency's approval. The Dec. 21 letter to San Diego-based Imprimis was posted on the FDA's website on ...
Tuesday, January 16, 2018
FDA expects IV fluid shortage to improve in coming weeks, months
Reuters-6 hours ago
“We understand that, with the shortage of filled bags, hospitals and other healthcare providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers,” he said. “This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten ...
FDA's Plan to Ease IV Saline Shortage Includes Expiration Date ...
AJMC.com Managed Markets Network-5 hours ago
AJMC.com Managed Markets Network-5 hours ago
| 12/05/2017 | Shanwei Honghui Daily Appliance Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/18/2017 | Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/19/2017 | Delta Laboratories Pty Ltd | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/20/2017 | Schrofner Cosmetics Gmbh | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 01/02/2018 | Yicheng Chemical Corp. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
| ||||||
Subscribe to:
Posts (Atom)