Sale of complementary medicines unethical: Australian doctors
BioEdge-6 hours ago
Criticism is mounting in Australia about the sale of low-evidence complementary medicines in pharmacies. An ABC radio report last month censured the ...
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
Saturday, April 30, 2016
Valeant files tardy financial report
San Jose Mercury News-3 hours ago
Valeant cut ties with Philidor last fall amid allegations that Philidor created a network of "phantom pharmacies" to steer pharmacybenefit managers toward ...
Valeant Pharmaceuticals Files Overdue US 2015 Financial Report
New York Times-20 hours ago
New York Times-20 hours ago
Explore in depth (132 more articles)
Diplomat to buy California-based TNH Advanced Specialty Pharmacy
pharmabiz.com-16 hours ago
Diplomat Pharmacy, Inc., the largest independent specialty pharmacy, has signed a definitive agreement to acquire Valley Campus Pharmacy, Inc., doing ...
Friday, April 29, 2016
Express Scripts to move faster to battle sudden drug price hikes
St. Louis Business Journal-13 hours ago
The pharmacy benefits manager (Nasdaq: ESRX) was discussing the benefit programs with its customers at its annual meeting Thursday in Florida, Chief ...
Express Scripts plans fiercer fight against sudden drug price hikes
Business Insurance-8 hours ago
Business Insurance-8 hours ago
Explore in depth (105 more articles)
Does videotape support CVS or fired pharmacist?
ModernMedicine-21 hours ago
That's the question a Richmond, Va. jury will decide in a case involving a pharmacist who accuses the retail giant of defamation, false imprisonment, malicious ...
Valeant tries corporate housecleaning
USA TODAY-7 hours ago
... be ugly," with some impairments and depressed earnings" as the company moves further into its prescription distribution deal withpharmacy giant Walgreens.
Valeant files overdue financial report, ending debt default, but its ...
In-Depth-Los Angeles Times-6 hours ago
In-Depth-Los Angeles Times-6 hours ago
Explore in depth (94 more articles)
DEA National Prescription Drug Take-Back Day is April 30
Pharmacy Today, American Pharmacists Association, pharmacist.com-1 hour ago
To find the nearest participating pharmacy or law enforcement department, visit the DEA website and select “Locate a collection site near you.” The website also ...
PillPack ends spat with huge prescription benefits company
The Boston Globe-5 hours ago
Express Scripts Holding Co. had planned to remove PillPack from its network of approved pharmacies at the end of April, saying the smaller company violated
Pharma companies accused of manipulating patents
Pharmacy News-20 hours ago
Access to cheaper and better drugs is being hampered in Australia by canny manipulation of patent regulations by pharmaceutical companies, the Productivity .
Prince Cops Search Singer's Pharmacy for Clues
Authorities descended on a Walgreens near Paisley Park and served a search warrant on the pharmacy, TMZ ...
TMZ.com - 5 hours ago
Authorities raid Minnesota Walgreens where Prince reportedly picked up prescriptions for heavy-duty medications
New York Daily News - 4 hours ago
FDA 483 dated 10/09/2015 Ambient Healthcare of Central Florida Inc. State Referral Letter FL Producer of Sterile Drug Products posted 04/29/2016
| 10/09/2015 | 3010810839 | Ambient Healthcare of Central Florida Inc. | State Referral Letter | FL | Producer of Sterile Drug Products | 04/29/2016 |
Federal judge enters order of permanent injunction against Paul W ...
FDA.gov-4 hours ago
“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Janet Woodcock, director of the FDA's Center .
New Board of Pharmacy Regulations Significantly Narrow the Sole Proprietor Exemption and Impose New Compounding Standards Friday, April 29, 2016 - See more at: http://www.natlawreview.com/article/new-board-pharmacy-regulations-significantly-narrow-sole-proprietor-exemption-and#sthash.GNeURvQo.dpuf
New Board of Pharmacy Regulations Significantly Narrow the Sole...
The National Law Review-4 hours ago
New regulations from the Ohio State Board of Pharmacy now require any prescriber ... Ohio law defines “compounding” as the preparation, mixing, assembling, ...
Iowa Board of Pharmacy Meeting Scheduled for May 3-4, 2016
05/03/2016 - 9:00am to05/04/2016 - 4:30pm
“The American people must be protected from compounded sterile drugs that pose a risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.”
quoted from https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-former-owner-and-operator-compounding
District Court Enters Permanent Injunction Against Former Owner and Operator of Compounding Pharmacies to Enjoin Distribution of Certain Sterile Drugs Products
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, April 29, 2016
District Court Enters Permanent Injunction Against Former Owner and Operator of Compounding Pharmacies to Enjoin Distribution of Certain Sterile Drugs Products
The U.S. District Court for the Middle District of Florida entered a permanent injunction against Paul W. Franck, who has owned and operated numerous compounding pharmacies, to enjoin the distribution of certain sterile drugs products, the Department of Justice announced today.
“The American people must be protected from compounded sterile drugs that pose a risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.”
The department filed a complaint in the District Court at the request of the Food and Drug Administration (FDA), alleging that Franck violated the federal Food, Drug and Cosmetic Act (FDCA) by causing drugs to become adulterated and misbranded while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
As alleged in the complaint, Franck has owned and operated numerous compounding pharmacies in the state of Florida over the past 20 years and he was responsible for providing final approval for all decisions concerning manufacturing and quality operations. The complaint alleged that the defendant and/or his employees manufactured, processed, packed, labeled, held and/or distributed drugs, including sterile drugs such as antibiotics, antivirals, cardiovascular drugs, drugs for pain management and total parental nutrition.
In conjunction with the filing of the complaint, Franck agreed to settle the case. The permanent injunction entered by the court requires that Franck cannot manufacture, hold or distribute any sterile drugs at or from his facility unless and until his facility, equipment, processes and procedures used to manufacture, hold, or distribute drugs are established, maintained, operated and administered in conformity with the permanent injunction and all applicable laws and regulations and are adequate to prevent such drugs from becoming adulterated or misbranded as defined in the order. Franck must also, among other things, establish and maintain a system to report to FDA all adverse drug experiences associated with his drugs.
The complaint alleged that a FDA inspection of Franck’s Lab Inc., doing business as Trinity Care Solutions in May 2014, found conditions establishing that the drugs manufactured and distributed by the defendant were adulterated. For example, FDA observed dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the sterile manufacturing area, the area where non-sterile gowns were stored and donned, and the sink where employees prepared for sterile processing. In addition, as alleged in the complaint, FDA found other insanitary conditions, such as lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction; lack of positive air pressure in the clean room relative to surrounding rooms which compromises the cleanliness of the clean room’s air; and materials around the laminar flow hood’s vent that were not cleanable and were potential sources of viable and non-viable particles. The complaint alleged that the defendant violated the FDCA by causing articles of drug to become adulterated, in that they are prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health, while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
The complaint also alleged that FDA inspected the defendant’s pharmacy, Franck’s Lab Inc. dba Franck’s Compounding Pharmacy, between March and May 2012. As alleged in the complaint, FDA initiated this inspection following reports of eye infections in patients who had been administered an injectable sterile eye solution, Brilliant Blue G (BBG) and/or injectable drug products containing triamcinolone (triamcinolone drugs) that had been compounded by Franck’s Lab. As alleged in the complaint, FDA laboratory analysis of samples of the defendant’s compounded BBG collected during this inspection revealed that the drug was contaminated with a fungus as well as other microorganisms, and these fungus-type organisms matched the clinical isolates from patients who developed eye infections after administration of this drug.
The complaint alleged, among other things, that the defendant violated the FDCA by causing drugs to become adulterated in that they consisted in whole or in part of a filthy, putrid, or decomposed substance, while such drugs were held for sale after shipment of one or more of their components in interstate commerce and that because the defendant’s purportedly sterile drugs contained microbiological contamination, the defendant’s labeling for such drugs was false or misleading. According to the complaint, as of March 2013, the U.S. Center for Disease Control had identified 47 cases of eye infections among 45 patients in nine states linked to exposure to the defendant’s BBG and/or triamcinolone drugs.
In addition, as noted in the complaint, the defendant has conducted a number of recalls of drugs over the years manufactured and distributed from his pharmacies.
As part of the proposed consent decree submitted to the court, the defendant represented that as of the date of the entry of the decree, he is not engaged in the manufacture, holding, or distribution of any drugs, nor he is causing the manufacture, holding, or distribution of drugs. The permanent injunction provides that if the defendant intends to resume manufacturing, holding or distributing any drugs at or from his facility, he shall notify FDA in advance of doing so.
The permanent injunction includes limited, precise exceptions for drugs for animal use or any drug for which the defendant is the sponsor of a new drug application approved by FDA.
“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Director Janet Woodcock of the FDA’s Center for Drug Evaluation and Research. “Today’s action reflects the FDA’s continued efforts to take appropriate and aggressive enforcement action against those who put patients’ health at risk by choosing not to follow the law.”
The government is represented by Trial Attorney Roger Gural of the Civil Division’s Consumer Protection Branch, with the assistance of Senior Counsel Michele Svonkin of the Department of Health and Human Services’ Office of General Counsel – Food and Drug Division.
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Topic:
Consumer Protection
Updated April 29, 2016
Thursday, April 28, 2016
Prescription drug compounding is beginning to turn a corner ...
11 hours ago - By definition, compounding is a practice through which a licensed pharmacist or physician (or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist) combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
Adamis Pharmaceuticals: Multi-Year Highs After Recent USCompounding Acquisition
Adamis acquires US Compounding, a compounding pharmacy with $20M+ yearly revenues and FDA approved manufacturing
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OSBP 2016 CE CONFERENCE
The Oklahoma State Board of Pharmacy will be hosting a half-day continuing education conference on Thursday, June 23, 2016. This event, including lunch, is being funded entirely by the Board to further its mission of protecting the health, safety and welfare of the citizens of Oklahoma.
A "Review of USP Chapter <797> for the Pharmacy Professional" will bepresented by Heith A. Crosby, Pharm.D., Ph.D., RCCP-SC (Registered Cleanroom Certification Professional in Sterile Compounding). The program is approved for three (3) hours of ACPE-accredited continuing education. Lunch is included with registration and will be served at noon with the program starting promptly at 1:00 p.m. Attendance is limited to the first 300 pharmacists who register.
Date & Location:
Thursday, June 23, 2016
Oklahoma Sports Hall of Fame Event Center
4040 N Lincoln Blvd
Oklahoma City, OK
Thursday, June 23, 2016
Oklahoma Sports Hall of Fame Event Center
4040 N Lincoln Blvd
Oklahoma City, OK
Sign-In:
11:00 am - 12:00 pm
11:00 am - 12:00 pm
Lunch: (no cost- included with free registration)
12:00 pm - 1:00 pm
12:00 pm - 1:00 pm
Program:
1:00 pm - 4:30 pm
1:00 pm - 4:30 pm
REGISTRATION:
Reservations will be accepted on a first-come basis. Email the following information to sdozal@pharmacy.ok.gov to reserve a spot:
Reservations will be accepted on a first-come basis. Email the following information to sdozal@pharmacy.ok.gov to reserve a spot:
- Name
- OK DPh License #
- e-Profile ID #
- Birth Month/Day
View Conference Flyer:
Suspicious' prescription led to lawsuit
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A federal judge in Texas has blocked a Texas pharmacy
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Wednesday, April 27, 2016
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Valeant Was Too Aggressive in Raising Drug Prices, CEO Says
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GROUPS LOBBY SENATE AG APPROPRIATORS ON DRUG COMPOUNDING — Six groups are calling on Senate appropriators today to ensure that the language in the FY 2017 agricultural spending bill "does not impede FDA’s ability to ensure patient safety" by hampering new guidance on drug compounding. The groups — an unusual coalition that includes the American Public Health Association, Biotechnology Industry Organization, Generic Pharmaceutical Association, Pew Charitable Trusts, Pharmaceutical Research and Manufacturers of America and Trust for America’s Health Read more: http://www.politico.com/tipsheets/politico-pulse/2016/04/what-valeants-ceo-will-tell-the-senate-today-213990#ixzz473Tua2uu
What Valeant's CEO will tell the Senate today
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