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Thursday, April 30, 2015

Another COA from Attix Pharmaceuticals for Human Chorionic Gonadotropin with address in both Canada and in Weatherford, TX

Look at this Certificate of Analysis for Progesterone from Attix Pharmaceuticals

Feds indict Vestavia Hills doctor on 10 charges related to Jasper 'pill .-- with 10 counts of unlawfully distributing controlled substances "outside the scope of professional practice and not for a legitimate medical purpose"

Feds indict Vestavia Hills doctor on 10 charges related to Jasper 'pill ...

AL.com-6 hours ago
The indictment was announced by U.S. Attorney Joyce White Vance,DEA Assistant Special Agent in Charge Clay A. Morris and IRS Criminal Investigation ...

“US Supreme Court sharply divided

Manufacturer asks Oklahoma to return any execution drugs


Manufacturer asks Oklahoma to return any execution drugs
U-T San Diego-3 hours ago
FILE - This Friday, July 25, 2014 file photo shows bottles of midazolam at a hospital pharmacy in Oklahoma City. In a March 4, 2015 letter, Akorn, the ...

Medicare Releases Detailed Look at Prescription-Drug Spending


Medicare Releases Detailed Look at Prescription-Drug Spending
Wall Street Journal-5 hours ago
The new data are drawn from the Medicare program known as Part D, which covers most drugs sold through retail and mail-orderpharmacies, and comes amid ...
Medicare Releases Detailed Data on Prescription Drug Spending
New York Times-1 hour ago

UPDATE 1-Nexium, Advair led Medicare drug spending in 2013 ...
Reuters-5 hours ago

Medicare data show contrast in generic, brand prescribing

The Missoulian-1 hour ago
Explore in depth (18 more articles)

More and more women are getting antibiotic-resistant UTIs; This New Drug Might One Day Cure Even the Most Painful UTIs

Omnicare said to be drawing interest from Express Scripts and CVS


Omnicare said to be drawing interest from Express Scripts and CVS
STLtoday.com-7 hours ago
Pharmacy service provider Omnicare Inc., which is exploring a sale, has drawn interest from Express Scripts and CVS Health, Bloomberg reports, citing people ...
Omnicare said to draw interest from CVS and Express Scripts

Chicago Tribune-4 hours ago
Explore in depth (6 more articles)

Ontario Drug Benefit Formulary Edition 42

Ontario Drug Benefit Formulary Edition 42

www.health.gov.on.ca/...
Ontario Ministry of Health and Long‑Term Care
10 hours ago - Part IV Consolidated Alphabetical Index of Drug Products Listed in Part III-B ....... IV.1 ...... “drug or combination of drugs prepared or compounded in a pharmacy  ...

FDA: Viagra 007 contains hidden drug ingredient

Medication Health Fraud Public Notification: Viagra 007 contains hidden drug ingredient

FDA: Slim Forte Slimming Capsule contains hidden drug ingredient

Medication Health Fraud Public Notification: Slim Forte Slimming Capsule contains hidden drug ingredient

FDA: King of Romance contains hidden drug ingredient

Medication Health Fraud Public Notification: King of Romance contains hidden drug ingredient

FDA: Li Da Dai Dai Hua Slimming Capsule contains hidden drug ingredient

Medication Health Fraud Public Notification: Li Da Dai Dai Hua Slimming Capsule contains hidden drug ingredient

FDA: Black Panther contains hidden drug ingredient

Medication Health Fraud Public Notification: Black Panther contains hidden drug ingredient

Second Question of the Day April 30, 2015 What is being done and has been done ever since the early notice of contamination of api from Attix to make sure the heath and safety of humans and pets is protected? What processes do state boards of pharmacy have in place to make sure traditional compounding pharmacies who have used this api are notifying consumers and recalling any remaining preparations? What action are boards of pharmacy taking to accumulate all adverse reactions from these products especially the ones that customers may not make the connection with the api until they are notified (for example dog is given compounded preparation with this api, dies and until customers is aware of problem with api does not question dogs death)?


Question of the Day April 30, 2015 How many consumers in the US of compounded medications (human and animal) are getting recall notices based on the Attix Pharmaceutical recall of api from Jan. 5, 2012, and Feb. 13, 2015? Are state boards of pharmacy proactively working with these impacted compounding pharmacies to make sure all compounded products with this api is recalled or the patients are notified of the issue?


Attix Pharmaceuticals recalls hundreds of APIs from the U.S.

Attix Pharmaceuticals recalls hundreds of APIs from the U.S.
FiercePharma Manufacturing - 5 hours ago
According to Health Canada, Attix Pharmaceuticals is recalling all nonpenicillin APIs repackaged and ...

Tricare to start screening compound medications Friday

Tricare to start screening compound medications Friday

Military Times-16 minutes ago
But others — including some who ordered prescriptions directly from compounding pharmacies in recent months —may need to work with their pharmacists to ...

Updated FDA 2015 Pharmacy Inspections and Related Records including 483s released as of April 30, 2015

2015 Pharmacy Inspections and Related Records

FDA 483 The Wellness Pharmacy, LLC, Winchester, VA Issued 3/12/2015

FDA 483 Precision Pharmacy Center, LLC, Brea, CA Issued 4/1/2015

FDA 483 Fallon Wellness Pharmacy, LLC., Latham, NY issued 03/10/15

IACP Presents Issues and Concerns of the Compounding Pharmacist Community Today to FDA - International Academy of Compounding Pharmacists

IACP Presents Issues and Concerns of the Compounding Pharmacist Community Today to FDA - International Academy of Compounding Pharmacists

Record $374B Spent on Drugs: The Pain Medicine News Report

Texas is one of only five states that prohibit a physician's ability to dispense ; Introduced Version of SB 588 Bill Analysis and HB 1483 Analysis and Comparison

84(R) SB 588 - Introduced version - Bill Analysis

www.legis.state.tx.us/tlodocs/84R/analysis/html/SB00588I.htm

3 days ago - Texas is one of only five states that prohibit a physician's ability todispense ... S.B. 588 amends the Occupations Code to permit physicians and therapeutic  .

HB:  here

ScripNet CEO MESSAGE – Physician Dispensing, a National Problem That Must be Addressed at the State Level

CEO MESSAGE – Physician Dispensing, a National Problem That Must be Addressed at the State Level

Ooltewah doctor loses license after online prescribing scheme

Ooltewah doctor loses license after online prescribing scheme

Chattanooga Times Free Press-Apr 29, 2015
Starting in 2010, family practitioner Robert Alan Coles collaborated with a Texas man to prescribe the medications through an online business, called Central 

An innovation that could transform the drug industry faces a major hurdle

An innovation that could transform the drug industry faces a major ...

Business Insider-17 hours ago
How? Hypothetically, biosimilars designated as "interchangeable" could be swapped out at the level of the pharmacy, without any required input from a doctor.

Company sues Texas Medical Board over telemedicine restrictions


Company sues Texas Medical Board over telemedicine restrictions
Chron.com-12 hours ago
The board would allow telemedicine without a prior visit only if patients are at a health facility, such as a hospital, clinic or even apharmacy, and have a health ...
Teladoc files for IPO
ModernHealthcare.com-22 hours ago
Explore in depth (13 more articles)

Seeking to block new rules restricting doctors from treating patients they've never met, the nation's largest telemedicine company sued the Texas Medical Board ...

Cigna sued over mail-order HIV med requirements

Cigna sued over mail-order HIV med requirements

Miami Herald-18 hours ago
Interaction with a pharmacist opens an avenue for asking questions and creating relationships — things that don't happen in the mail-order system, Schmid said.

FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics Product use should continue in health care setting as additional data are gathered


For Immediate Release

April 30, 2015

Release

The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.
“Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.” 
Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. They include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. The most common active ingredients in health care antiseptics marketed under the over-the-counter drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.
Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease. The FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe.
Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.
Emerging science also suggests that for at least some health care antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.
“Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” said Theresa Michele, M.D., director of CDER’s Division of Nonprescription Drug Products. “Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.”
The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.
The proposed rule will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, followed by a 60-day rebuttal comment period. The FDA will then evaluate all the data and comments that were received in response to this proposal to make a final determination regarding GRASE status for each active ingredient.  The FDA’s final determination will be published as a final rule (final monograph).
Today’s action is part of the FDA’s larger, ongoing review of monograph antiseptic active ingredients to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect health care antiseptics approved under the New Drug Application process, consumer antiseptic products (consumer antibacterial soaps) or consumer hand sanitizers.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###

Inquiries

Media

 Andrea Fischer
 301-796-0393

Consumer Inquiries

 888-INFO-FDA

Essential Read!! FDA Enforcement Reports April 29, 2015-Very Long List of Attix Pharmaceutical API

Enforcement Reports April 29, 2015

Constituent Updates FDA Seeks Public Comment on Risk Assessment of Drug Residues in Milk and Milk Products

Constituent Updates FDA Seeks Public Comment on Risk Assessment of Drug Residues in Milk and Milk Products

New draft of medical innovation bill boosts NIH funding


A new draft of House legislation that creates significant new regulatory leeway for drug and device companies includes more funding for the National Institutes of Health, representing a compromise with Democrats who withdrew support for the bill.  READ MORE

Catamaran Corporation announces strong first quarter financial results

Catamaran Corporation announces strong first quarter financial results

CNNMoney-1 hour ago
On March 29, 2015, the Company entered into a definitive agreement to combine with OptumRx, UnitedHealth Group's free-standing pharmacy care services .

Express Scripts isn't interested in owning a drugstore chain, as its pharmacy benefits management competitor CVS Health Corp. does; Express Scripts delayed billions in buybacks to evaluate

  1. Express Scripts delayed billions in buybacks to evaluate deals

    NorthJersey.com-21 hours ago
    Express Scripts isn't interested in owning a drugstore chain, as its pharmacy benefits management competitor CVS Health Corp. does. "Our standalone model ...

CVS Health Announces New Clinical Affiliations

CVS Health Announces New Clinical Affiliations with Leading ...

MarketWatch-22 hours ago
MinuteClinic, CVS/pharmacy and the participating health care organizations will ... a leading pharmacy benefits manager with nearly 65 million plan members, ...
CVS Health Corp Upgraded at Vetr Inc. (CVS)
WKRB News-7 hours ago
Explore in depth  (18 more articles)

Australia:Public trust the pharmacy profession: poll Pharmacy News-6 hours ago

Public trust the pharmacy profession: poll

Pharmacy News-6 hours ago
The latest Roy Morgan Image of Profession Survey shows that a very large majority of Australians aged 14 and over rate pharmacistsamong the most trusted ...

London:Pharmacy customer satisfied with response after medical documents found discarded in recycling bin outside an apartment building

Pharmacy customer satisfied with response after medical documents ...

CTV News-13 hours ago
He is one of nine people whose medical information was found in a recycling bin outside an apartment building at 425 King Street, next to the pharmacy.

More Articles Covering the recent HIPPA Settement with Cornell Prescriptoin Pharmacy in Denver

Blog: Colorado Pharmacy Reaches HIPAA Settlement with OCR ...

JD Supra (press release)-18 hours ago
Yesterday, the U.S. Department of Health and Human Services' Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy of Denver, ...
HIPAA Settlement Follows Unsecured Paper Records Disposal
The National Law Review-17 hours ago
Explore in depth  (8 more articles)

Wednesday, April 29, 2015

American Association of Bovine Practitioners (AABP) has created "Drug Use Guidelines for Bovine Practice" to assist beef and dairy veterinarians in guiding appropriate, effective and legal drug use on cattle operations. (guidelines attached)

Pharmacists Warn of Ophthalmic Drug Shortages FDA Dr. Chambers reminds that "the FDA is also charged with maintaining the safety of drugs and devices. "There are consequences to marketing unapproved products,'" Harrison April 29, 2015

FDA Releases Guidance on Biosimilars

FDA Hearing on Homeopathic Medicines: What Is the Role of the Compounding Pharmacist?

FDA Hearing on Homeopathic Medicines: What Is the Role of the Compounding Pharmacist?

From the FDA: Fatloss Slimming Beauty contains hidden drug ingredient

Medication Health Fraud Public Notification: Fatloss Slimming Beauty contains hidden drug ingredient

From the FDA: Superior contains hidden drug ingredient

Medication Health Fraud Public Notification: Superior contains hidden drug ingredient

Texas Board of Pharmacy Proposed Rule Chapter 291 Concerning Pharmacies (Non-Resident Pharmacy (Class E)) (§§291.101-291.106)


  1. C.3.1.1  Chapter 291 Concerning Pharmacies (Non-Resident Pharmacy (Class E))
    (§§291.101-291.106) (Tab 13) 

Question of the Day April 29, 2015 Texas Board of Pharmacy has a contract with "Analytical" according to their May 5, 2015 agenda to do compounded pharmaceutical analysis. Does anyone have anymore information on this company? Does the fact that the original cost was $95,000 and the amended cost is now $190,000 mean the Texas Board of Pharamcy is having a lot more compounded preparations tested or were the charges for the services increased for other reasons?


VENDOR
First Lab Analytical
Erin Feil TIBH-Peak B&H Photo Threads
REASON
1 year extension
1 year extension, increase by 100%

Increase by 100% Increase over 100% Increase over 100% Increase by 35%
Original Cost
$0.00 $95,000.00 $1,000.00 $3,223.92 $99.00 $76.00
Amended Cost
$0.00 $190,000 1 $2,000.00 $6,754.88 $199.00 $103.00
Original Term End
8/31/2014 8/31/2014 8/31/2015
completion of services receipt of goods receipt of goods


Amended Term
8/31/2015 8/31/2015
Description
Drug screening
Compounded pharmaceutical analysis

Wellness Grant - Yoga classes
Temporary employee, Enforcement Replacement projector bulb
Shirts, presented as service awards to staff




  1. 1 $190,000 is cummulative total for FY14-15

     Texas Board of Pharmacy Agenda for May 5, 2015 Meeting: Consideration of Material Changes to Contracts for Goods and Services Awarded Under Chapter 2155 of Texas Government Code (Tab 18) 

Texas Board of Pharmacy Agenda for May 5, 2015 Meeting (contains several compounding topics or compounding-related topics)

MAY 5, 2015

FDA Law Blog: April 28, 2015 Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics By Riëtte van Laack –

Read here

Recent Ninth Circuit Decisions in False Advertising Consumer Class

  1. Recent Ninth Circuit Decisions in False Advertising Consumer Class ...

    The National Law Review-16 hours ago
    When it comes to food and cosmetics, the applicable law is the Food, Drug, and ... The defendant in Reid argued that, because the FDA's regulations allowed a ...

Healthcare train doesn’t make it out of station before House calls it quits

Healthcare train doesn't make it out of station before House calls it ...

SaintPetersBlog (blog)-11 hours ago
The bill also grants healthcare practitioners and pharmacists immunity from civil and criminal liability and professional discipline, related to prescribing and ...

State: More Than 1000 Died Of Opioid-Related Overdoses In 2014

State: More Than 1000 Died Of Opioid-Related Overdoses In 2014

WBUR-20 hours ago
OxyContin pills are arranged at a pharmacy in Montpelier, Vt. in this 2013 file photo. Opioid drugs include OxyContin. (Toby Talbot/AP). By Benjamin Swasey.

Express Scripts plans share buyback as profit matches estimates

Express Scripts plans share buyback as profit matches estimates

NorthJersey.com-16 hours ago
UnitedHealth Group Inc.'s OptumRx pharmacy-benefits unit agreed in March to pay $12.8 billion for rival Catamaran Corp. The combined firm would be the No.
Express Scripts meets 1Q profit forecasts
TheNewsTribune.com-10 hours ago

Prescription Drugs Labels Under Fire

Prescription Drugs Labels Under Fire

NBC Connecticut-10 hours ago
When you pick up your prescription, do you stop to read all the fine print about possible risks associated with it? Or do you assume your doctor must know ...

Mulligans opens Ireland's first 'drive-thru' pharmacy and lifestyle store

  1. Mulligans opens Ireland's first 'drive-thru' pharmacy and lifestyle store

    Businessandleadership.com-1 hour ago
    Within the pharmacy a new 'lifestyle' experience is being offered with high-tech facilities on offer including skin analysis being carried out by professionally ...

Prescription drugs and sharing - Culture - The State Hornet

Prescription drugs and sharing - Culture - The State Hornet

China Jo-Jo's subsidiary, Jiuzhou Pharmacy inks new sales ..

  1. China Jo-Jo's subsidiary, Jiuzhou Pharmacy inks new sales ...

    pharmabiz.com-2 hours ago
    The purpose of the agreement is to double the sales of Wyeth's consumer healthcare products in 2015. Jiuzhou Pharmacy has been partnering with Wyeth since ...