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, July 31, 2014
UPDATE: Four doctors arrested in clinic raids | 2014-07-25 | Indianapolis Business Journal | IBJ.com
UPDATE: Four doctors arrested in clinic raids | 2014-07-25 | Indianapolis Business Journal | IBJ.com
Veterianary Sales Representative Jobs Seem to be in Abundance
Eli Lilly and Company - Tulsa, OK
Provides a key leadership role for distributor representatives within their assigned geography Responsible for product placement with targeted accounts in assigned geographical area Responsible...
07/25/2014
Dallas, TX
Veterinary Sales Representative Dallas, TX Our client is hiring a Veterinary Sales Representative for their Dallas, TX territory to generate sales by calling on existing customers, sales leads and...
07/16/2014
Seattle, WA
Veterinary Sales Representative Seattle, WA Our client is hiring a Veterinary Sales Representative for their Seattle, WA territory to generate sales by calling on existing customers, sales leads...
07/16/2014
SWL Recruiting - Richmond, VA
Specialty Sales Representative- Animal Health Our client isa leader inClinicalproducts andservices that are marketed to the Animal Health Market. They have asked us to locate a Sales...
07/15/2014
SWL Recruiting - Oklahoma City, OK
Specialty Sales Representative- Animal Health Our client isa leader inClinicalproducts andservices that are marketed to the Animal Health Market. They have asked us to locate a Sales...
07/15/2014
Phoenix, AZ
Our client is hiring Veterinary Sales Representatives in multiple regions across the United States to generate sales by calling on existing customers, sales leads and potential animal health or...
07/11/2014
HCCA September Health Care Privacy Basic Compliance Academy September 8-11, 2014
September Health Care Privacy Basic Compliance Academy
September 8-11, 2014
San Francisco, CA
HCCA's Health Care Privacy Basic Compliance Academy is a three-and-a-half-day intensive training program focusing on subject areas at the heart of health care privacy compliance practice. Its faculty is made up of experts in the field. Courses are designed for participants who have a basic knowledge of compliance concepts and some professional experience in a compliance function. Attendees gain comprehensive knowledge of the following:
- Policies, Procedures and Infrastructure
- Corporate Responsibility
- Risk assessment
- Education and Training
- Routine Auditing and Monitoring
- Stark and Anti-Kickback
- HIPAA Privacy and Security
- Conflict of Interest
The Academy addresses methods for implementing and managing compliance programs based on the Seven Element Approach. Courses cover subject matter in each of these areas and better prepare interested parties for the CHPC exam.
Registration Fees
Member Registration | $2500.00 |
Non-Member Registration | $3000.00 |
Janis Anfossi JD,CHC% - Assoc Vice President, Rush University Medical Center - Chicago, IL
Brian D Annulis CHC,JD,MHA - Partner, Meade Roach & Annulis, LLP - Chicago, IL
Dwight Claustre CHC-F, CHRC CHRC, CHC-F - Director, AEGIS Compliance & Ethics Center, LLP - Sun City West, AZ
Darrell W Contreras CHC-F,CHPC,CHRC,Esq. - Partner, PlusDelta Technologies, LLC - Lakeland, FL
John C Falcetano CCEP-F,CCEP-I,CHC-F,CHPC,CHRC,CIA CICA - Chief Audit & Compliance Officer, Vidant Health - Greenville, NC
Gregory V Kerr CHC,CHPC MJ - Director of HIPAA Compliance, - Fort Myers , FL
David B Nelson CIPP CISSP, CIPP/G, CIPP/US - Privacy Consultant, - Sacramento, CA
Joan M Podleski CHPC,CHRC,CCEP - Compliance Professional, - Durham, NC
R. Brett Short - Chief Compliance Officer, UK HealthCare / University of Kentucky - Lexington, KY
Debbie Troklus CCEP-F,CCEP-I,CHC-F,CHPC,CHRC - Managing Director, Meade Roach & Annulis, LLP - Louisville, KY
Brian D Annulis CHC,JD,MHA - Partner, Meade Roach & Annulis, LLP - Chicago, IL
Dwight Claustre CHC-F, CHRC CHRC, CHC-F - Director, AEGIS Compliance & Ethics Center, LLP - Sun City West, AZ
Darrell W Contreras CHC-F,CHPC,CHRC,Esq. - Partner, PlusDelta Technologies, LLC - Lakeland, FL
John C Falcetano CCEP-F,CCEP-I,CHC-F,CHPC,CHRC,CIA CICA - Chief Audit & Compliance Officer, Vidant Health - Greenville, NC
Gregory V Kerr CHC,CHPC MJ - Director of HIPAA Compliance, - Fort Myers , FL
David B Nelson CIPP CISSP, CIPP/G, CIPP/US - Privacy Consultant, - Sacramento, CA
Joan M Podleski CHPC,CHRC,CCEP - Compliance Professional, - Durham, NC
R. Brett Short - Chief Compliance Officer, UK HealthCare / University of Kentucky - Lexington, KY
Debbie Troklus CCEP-F,CCEP-I,CHC-F,CHPC,CHRC - Managing Director, Meade Roach & Annulis, LLP - Louisville, KY
Location Information
Sheraton Fisherman's Wharf Hotel
2500 Mason Street,
San Francisco, CA 94133
(415) 362-5500
The HCCA group rate is $209 single occupancy (additional person $20), plus applicable tax(es). This rate is good through August 8 or when the group room block is full, whichever comes first. To makes reservations, please call 1-888-627-7024 and as for the HCCA Privacy Compliance Academy group rate. $35 per day parking is available for attendees.
CHPC Certification
Be recognized for your experience and knowledge in health care privacy compliance. Take advantage of the opportunity to sit for an optional CHPC exam on the last day of the conference. The CHPC exam requires advance registration and payment separate from the conference registration. To qualify to sit for the CHPC exam, 20 CCB CEUs and the necessary work experience are required. For more information on the CHPC requirements click here.
To register to sit for the exam please submit the printable application to CCB byFax: 952.988.0146
Mail: 6500 Barrie Rd. Ste 250, Minneapolis, MN 55435Email: ccb @ compliancecertification.org
Mail: 6500 Barrie Rd. Ste 250, Minneapolis, MN 55435Email: ccb @ compliancecertification.org
Obtaining CEUs
To obtain CEUs for this conference, fill out the CEU Application given on-site at the conference, noting all sessions attended. Please contact us with questions +1.952.988.0141 or ccb@compliancecertification.org. Note that all credits will be awarded based on actual time on-site spent in session.
Approved Credit Types
CCB is in the process of applying for continuing education units. If you have questions, or if you do not see information on your specific accreditation, please contact CCB at ccb@compliancecertification.org or 888.580.8373.
CCB is in the process of applying for continuing education units. If you have questions, or if you do not see information on your specific accreditation, please contact CCB at ccb@compliancecertification.org or 888.580.8373.
AAPC:
This program has the prior approval of AAPC for 24 continuing education hours. Granting of prior approval in no way constitutes endorsement by AAPC of the program content or the program sponsor.
ACHE: The Health Care Compliance Association is authorized to award 24 hours of pre-approved ACHE Qualified Education credit (non-ACHE) for this program toward advancement, or recertification in the American College of Healthcare Executives. Participants in this program wishing to have the continuing education hours applied toward ACHCE Qualified Education credit should indicate their attendance when submitting application to the American College of Healthcare Executives for advancement or recertification.
AHIMA: This program has been approved for 24 continuing education unit(s) for use in fulfilling the continuing education requirements of the American Health Information Management Association (AHIMA). Granting prior approval from AHIMA does not constitute endorsement of the program content or its program sponsor.
Compliance Certification Board (CCB): Certified in Healthcare Compliance (CHC), Certified in Healthcare Compliance-Fellow (CHC-F), Certified in Healthcare Privacy Compliance (CHPC), Certified in Healthcare Research Compliance (CHRC), Certified Compliance & Ethics Professional (CCEP), Certified Compliance & Ethics Professional-Fellow (CCEP-F), Certified Compliance & Ethics Professional-International (CCEP-I): CCB has awarded a maximum of 28.8 CEUs for these accreditations.
CLE: The Health Care Compliance Association/Society of Corporate Compliance and Ethics is a State Bar of California Approved MCLE provider, a Pennsylvania Accredited Provider, a Rhode Island Accredited Provider, and a Texas Accredited Sponsor. An approximate maximum of 24 clock hours of CLE credit will be available to attendees of this conference. All CLE credits will be awarded based on individual attendance.
NASBA/CPE: The Health Care Compliance Association is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE sponsors, Sponsor Identification No: 105638. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit and may not accept one-half credits. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN 37219-2417. Website:www.nasba.org.
Deaware State Board of Pharmacy Licensing Outsourcing Facilities
Board Licensing Outsourcing Facilities
On June 18, 2014, the Delaware State Board of Pharmacy
unanimously agreed to license “outsourcing pharmacies”
as described under Section 503B of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). On November
27, 2013, the president signed into law the Drug Quality
and Security Act, legislation that contains important
provisions relating to federal and state oversight of compounding
of human drugs. The new legislation creates a
new section 503B in the FD&C Act under which a facility
that compounds sterile drugs can register to become
an “outsourcing facility.” An outsourcing facility can
qualify for exemptions from Food and Drug Administration
(FDA) approval requirements and the requirement to
label products with adequate directions for use, but it still
must comply with current good manufacturing practice
requirements. The registration of pharmacies as outsourcing
facilities will help FDA identify and more effectively
regulate these facilities. FDA intends to continue to partner
with states in the oversight of drug compounding.
quoted from Delaware Board of Pharmacy August 2014 Newsletter
FDA’s final guidance on traditional compounding essentially unchanged
FDA announced the availability of its final guidance for traditional compounding, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, in the Federal Register on July 2. Reflecting the agency’s thinking on the compounding part of the Drug Quality and Security Act (the compounding and track-and-trace legislation signed into law late last year), the final guidance closely tracks the draft guidance.
APhA had submitted comments February 3 on the draft guidance. APhA’s comments focused on office-use compounding and limits on out-of-state distribution of compounded drug products, including a 5% limit on such drug products and a Memorandum of Understanding (MOU) between FDA and the states.
It appears that pharmacists can expect additional guidance with policy changes on both issues, according to Jillanne Schulte, JD, APhA Director of Regulatory Affairs.
“Essentially, FDA kept the guidance as it was,” Schulte said. “Based on the listening session with FDA last week, it sounds like they’ll be making policy changes in additional guidance (both for office use and the MOU) that has yet to be released.”
The final guidance doesn’t apply to registered outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act; the agency will issue this guidance separately. Guidance documents are suggestions or recommendations that do not establish legally enforceable responsibilities, according to FDA.
As intended by the Drug Quality and Security Act, FDA’s final guidance noted that traditional compounding under section 503A will continue to be overseen by states, not the agency.
quoted from here
Steroids In East Texas
By Will Johnson
Messenger Reporter
EAST TEXAS – As the summer winds downs, the excitement levels on the gridiron and on the volleyball courts will begin to ratchet up a notch. For most area seniors, this will be their last shot at athletic glory. A select few will have the opportunity to continue their athletic careers at the collegiate level. Some have already made verbal commitments to take their talents to a university or junior college.
Some are on the proverbial bubble and need a little help. Unfortunately, a few of these area athletes will use any means necessary to secure an opportunity to play college ball and hopefully receive a coveted shot at the big time. This includes wandering down a dark path into the world of steroids.
It is no secret that the Piney Woods of East Texas produces some of the best athletes in the state. Most are completely natural and get by on God-given talent, hard work and dedication to their respective sport. A certain few, however, will choose to try and enhance their athletic prowess with the aid of chemical substances.
The problems associated with steroid usage will be covered in the next article in this series and are often thought to be associated with those already at the collegiate level and/or in the professional sporting world.
While many may believe the problem has not bled into the high school ranks or at least not into the East Texas High School ranks, a Drug Enforcement Agency (DEA) raid in neighboring Cherokee County pulled back the pine curtain and could possibly expose a dirty little secret hidden right next door to Houston and Anderson Counties.
On Thursday of last week, law enforcement agencies raided a residence in the Mixon area of Cherokee County. Mixon is an unincorporated community between Jacksonville and Troup on State Highway 135. The Cherokee County Sheriff’s Office, Department of Public Safety (DPS) narcotics investigators and DEA agents were present at the time of the raid.
During the investigation, the authorities discovered containers of Anadrol (an oral anabolic steroid), Dianabol (an oral anabolic steroid) and Cialis (a sexual dysfunctional drug). In addition, a notebook of recipes and outlines for the manufacture of steroids was found.
Captain John R. Raffield, with the Cherokee County Sheriff’s Office was contacted about the raid and investigation and said the investigation is ongoing. He added the evidence collected at the scene had been sent to a lab for confirmation as to the exact composition of the seized ingredients/chemicals and expressed some surprise as to what the law enforcement agents believed they had uncovered.
“Steroid labs – we have a retired DEA Agent who is one of my investigators. In his 25 year career with the DEA, he said he had only seen three. The majority of the people who were out there (at the raid) from the DPS narcotics and DEA said they had only seen one in their career. It is just not something you commonly run across,” he said.
continue to read here
Messenger Reporter
EAST TEXAS – As the summer winds downs, the excitement levels on the gridiron and on the volleyball courts will begin to ratchet up a notch. For most area seniors, this will be their last shot at athletic glory. A select few will have the opportunity to continue their athletic careers at the collegiate level. Some have already made verbal commitments to take their talents to a university or junior college.
Some are on the proverbial bubble and need a little help. Unfortunately, a few of these area athletes will use any means necessary to secure an opportunity to play college ball and hopefully receive a coveted shot at the big time. This includes wandering down a dark path into the world of steroids.
It is no secret that the Piney Woods of East Texas produces some of the best athletes in the state. Most are completely natural and get by on God-given talent, hard work and dedication to their respective sport. A certain few, however, will choose to try and enhance their athletic prowess with the aid of chemical substances.
The problems associated with steroid usage will be covered in the next article in this series and are often thought to be associated with those already at the collegiate level and/or in the professional sporting world.
While many may believe the problem has not bled into the high school ranks or at least not into the East Texas High School ranks, a Drug Enforcement Agency (DEA) raid in neighboring Cherokee County pulled back the pine curtain and could possibly expose a dirty little secret hidden right next door to Houston and Anderson Counties.
On Thursday of last week, law enforcement agencies raided a residence in the Mixon area of Cherokee County. Mixon is an unincorporated community between Jacksonville and Troup on State Highway 135. The Cherokee County Sheriff’s Office, Department of Public Safety (DPS) narcotics investigators and DEA agents were present at the time of the raid.
During the investigation, the authorities discovered containers of Anadrol (an oral anabolic steroid), Dianabol (an oral anabolic steroid) and Cialis (a sexual dysfunctional drug). In addition, a notebook of recipes and outlines for the manufacture of steroids was found.
Captain John R. Raffield, with the Cherokee County Sheriff’s Office was contacted about the raid and investigation and said the investigation is ongoing. He added the evidence collected at the scene had been sent to a lab for confirmation as to the exact composition of the seized ingredients/chemicals and expressed some surprise as to what the law enforcement agents believed they had uncovered.
“Steroid labs – we have a retired DEA Agent who is one of my investigators. In his 25 year career with the DEA, he said he had only seen three. The majority of the people who were out there (at the raid) from the DPS narcotics and DEA said they had only seen one in their career. It is just not something you commonly run across,” he said.
continue to read here
Veterinarian, Beef Cattle Professional Service - Texas/Oklahoma
Veterinarian, Beef Cattle Professional Service - Texas/Oklahoma: Click the link provided to see the complete job description.
We Stand FIRM: Unintended Consequences of FDA Regulations
We Stand FIRM: Unintended Consequences of FDA Regulations: Eye surgeon Dr. Brian C. Joondeph described a crazy "unintended consequence" of FDA rules designed to "protect" patient...
FDA Increases Drug and Medical Device Imports Refusal Due to Improper Registration
Hampton, Virginia (PRWEB) July 31, 2014
The U.S. Food and Drug Administration (FDA) continues to refuse an increasing number of imports due to non-registered drug and medical device manufacturers and unlisted or unapproved drugs.[1]
FDA requires foreign drug and medical device manufacturers to register with the FDA before exporting products to the United States. At the time of registration, foreign facilities must identify a U.S. agent and list all drugs or devices intended for use in the United States.
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration."
"It's clear to us that FDA is increasing enforcement on these types of products," said Registrar Corp Vice President David Lennarz. "It is prudent for companies to make sure they comply before starting or continuing to export to the United States."
continue to read here
The U.S. Food and Drug Administration (FDA) continues to refuse an increasing number of imports due to non-registered drug and medical device manufacturers and unlisted or unapproved drugs.[1]
FDA requires foreign drug and medical device manufacturers to register with the FDA before exporting products to the United States. At the time of registration, foreign facilities must identify a U.S. agent and list all drugs or devices intended for use in the United States.
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration."
"It's clear to us that FDA is increasing enforcement on these types of products," said Registrar Corp Vice President David Lennarz. "It is prudent for companies to make sure they comply before starting or continuing to export to the United States."
continue to read here
FDA Outsourcing Facility Published in Federal Register
-
- www.ofr.gov/(S(hocfzv1iqvmfloypsyoixqsl))/.../2014-18111_PI.pdf
- ShareView shared post
concerning the labeling of drugs with adequate directions for use) and (2) section ...
FDA takes steps to help ensure the reliability of certain diagnostic tests
Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.
First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers.
Second, consistent with the requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by health care professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”
The companion diagnostics guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time. The ultimate goal of the final guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases. This guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.
While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use. The LDT notification to Congress provides the anticipated details of the draft guidance through which the agency would propose to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. The draft guidance would also propose to phase in enforcement of pre-market review for other high risk and moderate risk LDTs over time.
The agency intends to propose continuing to exercise enforcement discretion for low-risk LDTs, LDTs for rare diseases and, under certain circumstances, LDTs for which there is no FDA-approved or cleared test.
“With today’s notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements.
A provision in FDASIA requires the FDA to provide at least 60 days’ notice to Congress before the agency publishes for public comment any draft guidance on the regulation of LDTs. As such, the comment period will open at a later date when the draft guidances are published in the Federal Register and the public is alerted to the start of the comment period. The agency also intends to hold a public meeting during the comment period to collect additional input.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring 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 the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
continue to read here
First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers.
Second, consistent with the requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by health care professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”
The companion diagnostics guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time. The ultimate goal of the final guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases. This guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.
While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use. The LDT notification to Congress provides the anticipated details of the draft guidance through which the agency would propose to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. The draft guidance would also propose to phase in enforcement of pre-market review for other high risk and moderate risk LDTs over time.
The agency intends to propose continuing to exercise enforcement discretion for low-risk LDTs, LDTs for rare diseases and, under certain circumstances, LDTs for which there is no FDA-approved or cleared test.
“With today’s notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements.
A provision in FDASIA requires the FDA to provide at least 60 days’ notice to Congress before the agency publishes for public comment any draft guidance on the regulation of LDTs. As such, the comment period will open at a later date when the draft guidances are published in the Federal Register and the public is alerted to the start of the comment period. The agency also intends to hold a public meeting during the comment period to collect additional input.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring 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 the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
continue to read here
FDA Cell Based Products for Animal Use
CVM Update – FDA Issues Draft Guidance for Industry on Cell-Based Products for Animal Use – http://www.fda.gov/ AnimalVeterinary/NewsEvents/ CVMUpdates/ucm407376.htm
Draft Guidance of Industry #218 - Cell-Based Products for Animal Use – http://www.fda.gov/downloads/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM405679. pdf
Form 8-K for THERAPEUTICSMD, INC. --clinical trials for advanced hormone therapy
Form 8-K for THERAPEUTICSMD, INC.
30-Jul-2014Other Events
Item 8.01. Other Events. On July 30, 2014, TherapeuticsMD, Inc., a Nevada corporation, filed a prospectus supplement with the Securities and Exchange Commission under its effective shelf registration statements on Form S-3 (the "Prospectus") pursuant to Rule 424 promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The discussion below contains certain updated disclosures regarding the Company's business included the Prospectus. Unless the context otherwise requires, all references in this Current Report on Form 8-K to "TherapeuticsMD," "TXMD," "Company," "our company," "we," "us," or "our" refer to TherapeuticsMD, Inc., a Nevada corporation, and its subsidiaries, VitaMedMD, LLC, a Delaware limited liability company, or VitaMed, and BocagreenMD, Inc., a Nevada corporation, or BocaGreenMD. vitaMedMD�, TherapeuticsMD�, and BocaGreenMD� are registered trademarks of our company.
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Are pharmacies the answer for less-costly pet Rxs?
Sens. Charles Schumer (D-NY) and Richard Blumenthal (D-Conn) said
pet owners are paying a 240% markup when they buy drugs from veterinarians.
During a recent press conference in New York City’s Greenwich
Village, the senators said a similar law for optometrists significantly lowered
the costs of contact lenses.
continue to read here
FDA has approved Targiniq™ ER, an opioid pain reliever designed to be more resistant to abuse. The drug is an extended-release/long-acting (ER/LA) opioid analgesic for treating pain severe enough to require around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.
read here
MedX Pharmacy Relocates to New Facility
The pharmacy announces new changes.
Sugar Land, TX (PRWEB) July 30, 2014
Wednesday, July 30, 2014
PCCA to Provide Seminar on Navigating Third-Party Billing for Compounded Medications as part of serve provided by Compounding Pharmacy Management Services (CPMS)
Navigating Third-Party Billing for Compounds
Summary
Compounds are different by their nature. And so are the approaches various third-party insurance companies take in paying them. If you bill third-party insurance, you’re already familiar with the hassles that often arise when trying to process a claim for a compounded prescription. Or maybe you’ve just heard about it and have avoided billing third-party altogether.
That’s where PCCA’s Third-Party Solutions steps in.
As part of a new service provided by Compounding Pharmacy Management Services (CPMS), this one-day workshop will cover the basics of third-party billing, including the ins and outs of version D.0. Then, the team will drill down and show you best practices for processing claims with the top insurance plans – including CVS Caremark, Express Scripts, Medco, and Prime Therapeutics. The team will dive deep into these plans to educate you on exactly what each plan will pay for. Benefit from our expertise so you can spend your valuable time on your most important task – serving patients.
Why should you attend?
That’s where PCCA’s Third-Party Solutions steps in.
As part of a new service provided by Compounding Pharmacy Management Services (CPMS), this one-day workshop will cover the basics of third-party billing, including the ins and outs of version D.0. Then, the team will drill down and show you best practices for processing claims with the top insurance plans – including CVS Caremark, Express Scripts, Medco, and Prime Therapeutics. The team will dive deep into these plans to educate you on exactly what each plan will pay for. Benefit from our expertise so you can spend your valuable time on your most important task – serving patients.
Why should you attend?
- If you’re already billing third-party insurance, we’ll teach you how to become more efficient, how to reduce audits, what to do when you do get audited and more.
- Learn best practices for billing, including training using PK Software’s billing programs. Not using PK Software at your pharmacy? No problem – the team will provide information for whatever software you’re using.
- And more!
Details
When
- Saturday, September 20, 2014
7:00 AM - 5:00 PM
Central Time
Where
- PCCA Learning Center
9901 South Wilcrest Dr.
Houston, Texas 77099
1-800-331-2498
One Quality Standard: OIG Issues Favorable Advisory Opinion on Drug Manu...
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List of Pharmacists, Pharmacies, Labs and Organizations That Donated Money to IACP for the Building of its Headquarters
Diamond Sponsor
Thomas and Alice Marks
Platinum Sponsor
Bob Seiwert, Sierra Compounding Pharmacy
Gold Sponsors
Lee and Mary Ann Berrettini
Gallipot
Bob and Diana Harshbarger
Health Care Logistics
Gary and Vicki Holst
International Journal of Pharmaceutical
Compounding
Marty Jones and Pat Baloga
Medaus on behalf of Steven Russell
Ray and Alfred Moreno, Universal Arts
Compounding Pharmacy of South Florida
in Honor and Praise of our loving
parents, Maximino and Maria Moreno
John D. and Caroline Musil and Family
David and Diane Nicoletti
PCCA
Sherry Ross
Bob and Janie Scarbrough
Spectrum Pharmacy Products
Eric Vidrine, Professional Arts Pharmacy
David Zava and ZRT Labs
Silver Sponsors
Analytical Research Laboratories
Bill Burch and Jennifer Burch
Pat and Jan Downing, Jenny Yoakum,
Dee Downing and Jana Downing
Eric Everett and Lisa Everett
Brian Fichter, VitaMaxRx, Inc.
Paul Franck
Dan and Laura Fucarino
Phil Hagerman, Diplomat Specialty
Eric and Carolyn Holgate
IACP Staff
Scott Karolchyk and Bernie Covalesky
Mike Leake
Terry and Greg Mielke, Thrifty Health
and Compounding
Donna Patterson, The Apothecary
Robert P. Potts and Associates
Sam and Mary Susan Pratt
John Preckshot
Kim and Janet Tenreiro
Evelyn Timmons and Steve Timmons
E. Pat Vann, Vann Healthcare Services
Gary Wilburn
Bronze Sponsors
Hank Abbott, Birds Hill Pharmacy
Eldon Armstrong, Hawthorne Pharmacy
Leo and Beverly Blais
Carie Boyd
Ben Briggs
Richard Brisson
Al Brown and Liberty Drug
James Buderer and Matthew Buderer,
Buderer Drug Co.
Steven Charles
Compounding Shop, Inc.
John and Alice M. DeMars
Gina Ford
Peter and Anne Marie Ford
Henry Gialanella
Jim Gillespie
Dana Gordon, CAPRx
Gene and Caren Gresh
John Herr and Robert Zadra
Hoagland Pharmacy
Dick Holm
Sue Horton and Central Iowa Compounding
Bob and Kathy Hoye
Bill and Barbara Johns
Raymond and Kathleen Knepp
Matthew H. and Jayne Kopacki
Mark Mandel and Nick Flocco
Mike and Keryn McMahan
Medisca
Rich and Kelly Moon, Southern Tier
Home Infusion
Moore’s Pharmacy, Inc.
Pine Pharmacy
North Dakota Compounders
Mike Pass
Scott and Amy Popyk, Health
Dimensions, Inc.
Wade and Jennifer Siefert
Marshall Tobin
William and Jonette Wills, Grandpa’s
Compounding Pharmacy
Joe Wise and Wise Pharmacy
Robert Wood and Anthony Buchta,
Central Ohio Compounding
Gene and Cheryl Zale
Mortar and Pestle Sponsors
Harvey and Carol Ahl
Patsy Angelle
Aquidneck Pharmacy and Wellness
Claude Banks
Jeff Barris, Pacifica Pharmacy
Jerry and Jean Beamer
Barry and Grace Bilbro
Eugene Bockrath
Douglas and Jennifer Boudreaux
Burman’s Pharmacy
Gene Carlson and Schott’s Pharmacy
Randy and Susan Caudle
Karl Clearwaters, Herbst Apothecary
David and Debbie Creecy, Poquoson
Pharmacy
Dr. Dan Daniel
Gerald and Cheryl DuFresne
Kim and Patricia Fulmer
Gary and Ruth Glisson
Henry and Myra Herring
Jeff Hill, Hill’s Compounding Pharmacy
Jeff and Angela Jackson
Kathy and Pat Jackson
Patty Johnston and Larry Frail,
Colony Drug
Dean and Linda King
L.D. King
Kubat Pharmacy
Deril and Robbin Lees
Leiter’s Pharmacy
Bill and Lise Letendre
David Liebman
Joe Lorello
Dick and Amelda McCortney
Randy and Paula Mentzer
Svet Milic
Bill and Jan Mixon
Lee and Jaclyn Ori
Jim and Amy Paoletti
Dean and Terri Parker
James Perry
Ron Petrin
Martin and Rosemary Pietruszewski
Rudy and Carole Prinz
Dana Reed-Kane and Tom Reed,
Reed’s Compounding
Jerrod and Drenda Roberts
Shara and Mike Rudner/George and
Barbara Grumet
Tony and Sandra Sabutis
Ari Schafer
Larry and Linda Shelton
Lee and Kerri Shinabery
Scott Snyder
David Stahlberger, Matthew H. and
Jayne Kopacki, Pompton Pharmacy
Mike and Debra Stein
Storey Marketing
Irv Swartz
Pat and Theresa Travis, CLEANAIR
David and Terry Vasenden
John and Tara Voliva
Scott and Gretchen Watts
Don and Karen West
Irene White and Dennis Slack
Gary and Brenda Wingate
Terry Wingo
Bill and Gloria Winkowski
Dana and Annette Woods
Patron Sponsors
Vern Allen, Premier Pharmacy Labs, Inc.
Jay and Lisa Ashworth
Nick Birkel, Pharmacy Specialty Services
Janice Bopp and Mar-Main Pharmacy
Janet Carter, Prescription Alternatives
Custom Dosing Pharmacy
Lizzie Dragon
Larry and Lezlie Durrant
Kevin and Beth Evetts
Glen Hadaway
Henry T. Hayden, Hayden Drug
Pete Hueseman, Bellevue Pharmacy
Solutions
Lorraine Kaup and Kaup Pharmacy
Craig and Sally Kvam
George and Barbara Muller
Andy Naglak
Neal and Ro Pease
Richard and Diantha Rochefort
Joe Rossetti
Scott Robinson’s Prescriptions/Bruce
Winkelman
John and Waynie Stephenson
Scott Wepfer
Susanne Williams
Individual Sponsors
Ray and Mary Sue Adams
Mel Alter
Kevin and Amy Atkins
Ball Ground Pharmacy
Ronnie Baggett
Janet Beard
Verne and Colleen Betlach
Bruce Biundo
Michael Blaire, Diamondback Drugs
Diane Boomsma and Merv Sands
Bill Chaney
Michael and Carol Collins
Charles Daleo
David and Nancy DeMartini
Dickson Apothecary
Disco Rex Pharmacy
Don Fellows
Ken Fitzgerald
W. Benjamin Fry
Robert Geldreich
Jennifer Goodrum
John and Joe Grasela, University
Compounding Pharmacy
Dale Harrison and Dr. Laurie Ellen
Spence
Mike and Marcia Haulsee
Rayeane and Bentley Hawley
Bruce A. Hinkle
Tom and Dot Hornsby
Ken and Nancy Hughes
Michael Hunter
Alan, Beverly and Adam Israel
Fred Kinnard, Kinnard’s Pharmacy
James Krasnow
Yvette Ladd, Halls Pharmacy
Eddie Tom Lakey
Jung and Marilynn Lee
A. Blair Lundberg
Larry Mayhew
Joe McCloskey
Linda F. McElhiney
Angie Meeker
Sammi Molvi, Health Solutions Pharmacy
Gary Newton
Patricia Paget
Roger Pennington, Westlab Pharmacy
Portage Pharmacy
Jeff and Stacy Robins
Rx South
Jade and Brenna Schuckman
Jim Schwartz, King Pharmacy #2
Kelly and Nancy Selby
Linn and Barbara Shaffer
Jeffrey B. Sherr, Apple Discount Drugs
Chris and Patti Simmons
Stephen F. Skinner, Specialty Pharmacy
Charles and Alleene Smith
In Honor of Kay Sparks
Jack and Carol Stafford
Gerald Stone, The Drug Shop
Angie Svoboda, Good Life Health Services
Bill Swail, Peoples Pharmacy
Tom Switzler
Tom and Tami Talbert, in Honor of
Kay Sparks
Tar Heel Drug
Dr. Eldred Taylor
Union Square Pharmacy
Cathy and Ron Windish
Steve Zaver
quoted from here
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