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Wednesday, August 31, 2016

Opaleye Management buys $4905225 stake in Imprimis ...

Trade Calls-15 hours ago
It makes dispenses and sells its compounded formulations as well as other non-proprietary products 

Flavoured Veterinary Medications Market : Dynamics, Segments ...

Medgadget (blog)-8 hours ago
... Zoetis Inc., Elanco Inc., Novartis, Merck Animal Health, Merial, Virbac, Ceva, Vetoquinol, Wedgewood Pharmacy, Lee Silsby Compounding Pharmacy.

News Article : FDA Starts Showing Its Plans for Oversight of Pharmacy Compounding

News Article : FDA Starts Showing Its Plans for Oversight of Pharmacy Compounding

California Board of Pharmacy Meeting Scheduled for September 22, 2016 (agenda not posted yet)

September 22, 2016Southern California

Alaska Board of Pharmacy Proposed Regulation Changes Relating to Overdose Drug

Public Notices

  • Proposed Regulations Changes
  • The Board proposes to establish standards for the independent dispensing by a pharmacist of an opioid overdose drug.
    Deadline at 5:00 p.m. on September 30, 2016.

Colorado Board of Pharmacy Meeting Scheduled for September 15, 2016

Board of Pharmacy Meeting
Thu, September 15, 8:30am – 3:30pm
1560 Broadway, Suite 110D, Denver, CO 80202
Pharmacy Public
andreae.faley@state.co.us
Agenda deadline is August 22, 201

Alabama Board of Pharmacy Meeting Scheduled for September 20-21, 2016 (agenda not posted yet)


Reminder! Changes in Texas Relating to Doctors and Pharmacists

Texas Controlled Substances Registration Numbers for Physicians and PAs:

Under Senate Bill 195, the requirement for controlled substances registration (CSR) with the Texas Department of Public Safety (DPS) will be eliminated beginning September 1, 2016.  Read more

Prescription Pad Orders:

Effective September 1, 2016, the Texas Prescription Program transfers to the Texas State Board of Pharmacy (TSBP). This includes the oversight and processing of the official prescription pads for Schedule II prescription forms. Read more

Utah Board of Pharmacy Meetings Scheduled in September 2016

State pharmacy board to consider banning deadly synthetic drug

WTTV CBS4Indy-15 hours ago
INDIANAPOLIS, Ind. -- The state pharmacy board will soon consider an emergency ban of a deadly new drug. In response to overdose deaths across the nation ...

DWC Posts Draft Drug Formulary Regulations for Public Comment

www.workerscompensation.com/.../24496-dwc-posts-draft-drug-formulary-regulatio...
23 hours ago - When it is necessary for medical reasons to prescribe or dispense a compounded druginstead of an FDA-approved drug or over-the-counter drug that complies ...

Michigan Veterinary Medical Association - Compounding Drugs and ...

michvma.org/compounding-drugs-controlle...
Michigan Veterinary Medical Association
9 hours ago - Compounding Drugs. In the fall of 2014, a bill was passed that became Public Act 280. This law was written for human medicine, but called into question the

EpiPen Main Ingredient Costs 'Less Than A Big Mac'

5newsonline.com-15 hours ago
Compounded drugs may be a tougher sell because of safety concerns. In 2012, a meningitis outbreak caused by a Massachusetts compounding pharmacy led

meningitis-etc: NECC Defendant Wants Access to Civil Trial Data

meningitis-etc: NECC Defendant Wants Access to Civil Trial Data: By Walter F. Roche Jr. A former drug company executive who is facing multiple second degree murder charges is seeking approval to use rec...

meningitis-etc: Judge Declines Request to Set Meningitis Claim Dea...

meningitis-etc: Judge Declines Request to Set Meningitis Claim Dea...: By Walter F. Roche Jr. Stating that any last minute changes would just bollix things up, a federal judge today refused a request to impos...

8 Florida Residents Charged for Compounding Pharmacy Fraud

The latest investigation by the Medicare Fraud Strike Force has resulted in charges against 8 Florida residents for counts of conspiracy to commit health care ...
Feds to distribute $53 million to states to fight opioids
The Obama administration says it will distribute $53 million to 44 states in an effort to curb opioid abuse.  READ MORE

Tuesday, August 30, 2016

Fred's Disappoints Amid Pharmacy Weakness

Wall Street Journal-5 hours ago
“We are disappointed with the company's performance, as comparable-store sales were down in front store, retail pharmacy and specialty pharmacy,” said Chief ...
Fred's pharmacy chain names new CEO
MarketWatch-19 hours ago

21 CFR 216.24 Pharmacy Compounding-Drug products withdrawn or removed from the market for reasons of safety or effectiveness

ELECTRONIC CODE OF FEDERAL REGULATIONS

e-CFR data is current as of August 26, 2016
Title 21 → Chapter I → Subchapter C → Part 216 → Subpart B → §216.24


§216.24   Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

The following drug products were withdrawn or removed from the market because such drug products or components of such drug products were found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate: All drug products containing adenosine phosphate.
Adrenal cortex: All drug products containing adrenal cortex.
Azaribine: All drug products containing azaribine.
Benoxaprofen: All drug products containing benoxaprofen.
Bithionol: All drug products containing bithionol.
Bromfenac sodium: All drug products containing bromfenac sodium.
Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil.
Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated casein.
Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.
Chlormadinone acetate: All drug products containing chlormadinone acetate.
Chloroform: All drug products containing chloroform.
Cobalt: All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives).
Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride.
Diamthazole dihydrochloride: All drug products containing diamthazole dihydrochloride.
Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose.
Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate.
Dipyrone: All drug products containing dipyrone.
Encainide hydrochloride: All drug products containing encainide hydrochloride.
Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride.
Flosequinan: All drug products containing flosequinan.
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: All drug products containing iodinated glycerol.
Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.
Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.
Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride.
Methapyrilene: All drug products containing methapyrilene.
Methopholine: All drug products containing methopholine.
Mibefradil dihydrochloride: All drug products containing mibefradil dihydrochloride.
Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatalogic application).
Nomifensine maleate: All drug products containing nomifensine maleate.
Oxyphenisatin: All drug products containing oxyphenisatin.
Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate.
Phenacetin: All drug products containing phenacetin.
Phenformin hydrochloride: All drug products containing phenformin hydrochloride.
Pipamazine: All drug products containing pipamazine.
Potassium arsenite: All drug products containing potassium arsenite.
Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).
Povidone: All intravenous drug products containing povidone.
Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine.
Sparteine sulfate: All drug products containing sparteine sulfate.
Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole (except those formulated for vaginal use).
Suprofen: All drug products containing suprofen (except ophthalmic solutions).
Sweet spirits of nitre: All drug products containing sweet spirits of nitre.
Temafloxacin hydrochloride: All drug products containing temafloxacin.
Terfenadine: All drug products containing terfenadine.
3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.
Ticrynafen: All drug products containing ticrynafen.
Tribromsalan: All drug products containing tribromsalan.
Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
Urethane: All drug products containing urethane.
Vinyl chloride: All aerosol drug products containing vinyl chloride.
Zirconium: All aerosol drug products containing zirconium.
quoted from eCFR

Brown's Compounding Center, Inc. Denver District Office Unapproved New Drug/Compounding/Misbranding/Adulterated Not Issued *

August 17, 2016Brown's Compounding Center, Inc.Denver District OfficeUnapproved New Drug/Compounding/Misbranding/AdulteratedNot Issued *
August 17, 2016Amniotic Therapies LLC.Center for Biologics Evaluation and ResearchCGMP/Deviations/Biologics License Application (BLA)Not Issued *

Central Admixture Pharmacy Services Inc Los Angeles District Office Unapproved New Drug/Compounding/Misbranding/Adulterated Not Issued *

August 18, 2016Central Admixture Pharmacy Services IncLos Angeles District OfficeUnapproved New Drug/Compounding/Misbranding/AdulteratedNot Issued *
August 19, 2016Xinxiang Tuoxin Biochemical Co. LtdCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated
June 20, 2016Vitalife Inc.Los Angeles District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *

Large contract with Express Scripts keeps Alphapointe growing

Kansas City Business Journal-18 hours ago
Now it's adding a private-sector contract with St. Louis-based Express Scripts, a leading pharmacy benefit management service provider that posted $2.48 billion

Exclusive investigation: Your prescriptions aren't private

WTMJ-TV (press release) (registration) (blog)-Aug 29, 2016
“No case number or other certification is required,” said Michael Goff, administrator of the controlled substance database for the West Virginia Board of Pharmacy ...

FDA Pushes Back Enforcement of UDI Rule Provisions

Regulatory Focus-16 hours ago
But on Monday, FDA said that after stakeholders, including supply chain participants, pharmacies and payers, said they would not be able to complete the work

The Truth About Omega-3 Supplements and St. John's Wort for ...

ConsumerReports.org-15 hours ago
Stroll through your local pharmacy or health food store and you'll likely see some dietary supplements purported to help ease depression. For example ...

Maine hospital agrees to pay $125K over handling of drugs

Washington Times-8 hours ago
The hospital in Fort Kent was accused of failing to maintain proper records of destruction of controlled drugs at a rehabilitation unit and an on-site pharmacy.

Sen. Joe Manchin backs suit by addicts who say docs and Big ...

Raw Story-21 hours ago
The lawsuit, which is expected to go to trial later this year, accuses doctors,pharmacies and distributors of conspiring to deliberately get them addicted to .

Valeant is sued over Philidor ties, alleged racketeering

Yahoo Finance-11 hours ago
If the Laval, Quebec-based company had not done this, the plaintiffs "would have denied claims submitted by pharmacies in the Valeant Enterprise and insisted ...

Latest JD Power survey reveals the two traits all good pharmacies ...

Drug Store News-20 hours ago
COSTA MESA, Calif. — High customer satisfaction with both mail order and brick and mortar pharmacies is reflective of an increased focus on customers and the ...

Ramsay Health Care lifts profit 17pc and unveils pharmacy push

The Australian Financial Review-12 hours ago
"Solid volume growth, ongoing efficiencies, strategic acquisitions, and further investment in our facilities, continue to underpin our strong financial performance," ...

Independent pharmacies critical to community

Reading Eagle-8 hours ago
*Some of the independent pharmacies are long-term care or other closed-doorpharmacies. Two independent pharmacies are hospital-based outpatient ..

Navy veteran says Kroger pharmacy pill mix-up caused his kidney ...

WLWT Cincinnati-13 hours ago
WLWT contacted the Ohio Board of Pharmacy in Columbus and was told, "Allpharmacies are required to account for any drugs received, kept on hand and ..

Walgreens combines mail-order pharmacy with Prime Therapeutics

USA TODAY-21 hours ago
Walgreens Boots Alliance said Monday that it had reached a deal to combine its mail-order pharmacy and specialty drug business with Prime Therapeutics, ...
Prime Therapeutics, Walgreens to form pharmacy alliance
Minneapolis Star Tribune-13 hours ago
  • National
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In the latest federal initiative aimed at combatting the national opioid crisis, U.S. Surgeon General Vivek Murthy is sending letters to 2.3 million clinicians, asking
… Read more »
  • State: California
  • Topic: WEST
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State Compensation Insurance Fund is asking the U.S. District Court for Central California to consolidate two cases alleging a widespread scheme of kickbacks for patient
… Read more »

Frazier Takes Majority Stake in Matrix Medical to Boost the Target's ...

Mergers & Acquisitions - The Middle Market-19 hours ago
... equity firm that has previously invested home medical services provider Abode Healthcare; Elements Behavioral Health and Leiter's Compounding Pharmacy

Monday, August 29, 2016

Must Read!! Pharmaceutical Compounding: The FDA Is Not The Problem - Forbes

Pharmaceutical Compounding: The FDA Is Not The Problem - Forbes

www.forbes.com/.../pharmaceutical-compounding-the-fda-is-not-the-problem/

Forbes
4 hours ago - BY JOSEPH GULFO -- Compounding pharmacies provide a critically-important service to patients, however, lack of appropriate oversight and enforcement has ..

Compounding Pharmacy Warned Over a Variety of Violations

Compounding Pharmacy Warned Over a Variety of Violations
Pharmaceutical Technology Magazine - 4 hours ago
Compounding Pharmacy Warned Over a Variety of Violations. FDA issued a warning letter to College Pharmacy for multiple violations. Aug 29, 2016.