Tuesday, December 31, 2013
December 31, 2013 Law regulating compounding pharmacies falls short
HealthDay News -- Additional steps are needed for regulating compounding pharmacies beyond those outlined in the Drug Quality and Security Act of 2013, some are warning.
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
continue to read here
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
continue to read here
Another Compounding Sales Opening in Georgia
Sales Representative Compounding Pharmacy
Towne Lake Family Pharmacy - Greater Atlanta Area
We are looking for independent sales professionals with experience calling into physician practices in Orthopedics, Pain Management, Sports Medicine, Podiatry, Rheumatology, Neurology, Family Practice, Internal Medicine.
A history of close personal relationships with physicians and their staff is a must in order to drive brand preference and referrals.
Job requires enthusiastic, self-motivated, self-directed individual to effectively manage the territory and work independently.
We offer a 20% share of the reimbursement with annual income potential of $250K+.
We welcome people seeking full-time or part-time positions.
Desired Skills and Experience
Professional and ethical character is of the utmost importance, while displaying a positive, can-do, team-oriented attitude.
Know the pain therapy market well and have represented pain products and /or have a solid list of physicians who treat acute and chronic pain.
Can demonstrate strong track record of success.
Excellent organizational, analytical and follow-up skills.
Must have a valid driver’s license in good standing.
quoted from here
Know the pain therapy market well and have represented pain products and /or have a solid list of physicians who treat acute and chronic pain.
Can demonstrate strong track record of success.
Excellent organizational, analytical and follow-up skills.
Must have a valid driver’s license in good standing.
quoted from here
About this company
Towne Lake Family PharmacyWe specialize in formulating topical transdermal pain cream compounds used to treat both acute and chronic neuropathic and inflammatory pain.
Topical treatment is used as a replacement or adjunct to oral opioid pain management therapy eliminating most major side effects as well as avoiding addiction.
Many patients are unable to take oral medications due to gastrointestinal (stomach, liver, kidneys), issues, which can significantly affect the patient’s quality of life.
Towne Lake Family Pharmacy is locally owned and offers superior customer service which includes facilitating prescription medication and expediting home medication delivery for patients WITHIN 24 HOURS BY LICENSED PHARMACISTS. We manage the claims process for patients, our experienced and devoted staff has worked closely with physicians and has extensive experience dealing with insurance companies AND coordinating
California Board of Pharmacy Enforcement and Compounding Committee Agenda for January 10, 2014
| January 10, 2014 | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda |
Answer to my Fourth Question of the Day on December 31, 2013 Regarding the cost of compounded pain medications: Thank you Dr. Kenneth Woliner for the comment
Sue,
Yes. The compounded pain creams may be useful for patients (or not), and are EXTREMELY LUCRATIVE FOR COMPOUNDING PHARMACIES and the sales reps they employ to get prescriptions from doctors all around the country (not just locally). Sometimes they are also lucrative to the prescribing physician through illegal kickbacks and split-fee relationships (e.g. Florida Board of Medicine v. David R. Balding, M.D. DOH 93-02958 - where the doctor was getting a 25% kickback on all compounded ketoprofen creme prescriptions - ALL IN CASH, as to not have a paper trail - http://ww2.doh.state.fl.us/FinalOrderNet/folistbrowse.aspx?LicId=42705&ProCde=1501&discpln=DISCPLN)
The way the SCAM part of this works is that:
- Active Pharmaceutical Ingredient (API) suppliers "artificially inflate" the "Average Wholesale Price (AWP) of the raw material drugs used in these creams by 1,000%, but will sell the API's to compounding pharmacies for a tenth of the AWP.
- Compounding Pharmacies bill insurance at the AWP (often $2,000 - $3,000 for a month's supply of transdermal cream), but get reimbursed by the insurance company at about 80% of billed charges. The insurance company may think they "negotiated a good deal", but in reality, they got scammed.
- The compounding pharmacy makes so much profit ($1,000 - $1,500 per prescription per month) that they can afford to pay outrageous commissions tomtheir sales reps (and sometimes, kickbacks to the prescriber).
Kenneth N. Woliner, M.D.
www.holisticfamilymed.com
Yes. The compounded pain creams may be useful for patients (or not), and are EXTREMELY LUCRATIVE FOR COMPOUNDING PHARMACIES and the sales reps they employ to get prescriptions from doctors all around the country (not just locally). Sometimes they are also lucrative to the prescribing physician through illegal kickbacks and split-fee relationships (e.g. Florida Board of Medicine v. David R. Balding, M.D. DOH 93-02958 - where the doctor was getting a 25% kickback on all compounded ketoprofen creme prescriptions - ALL IN CASH, as to not have a paper trail - http://ww2.doh.state.fl.us/FinalOrderNet/folistbrowse.aspx?LicId=42705&ProCde=1501&discpln=DISCPLN)
The way the SCAM part of this works is that:
- Active Pharmaceutical Ingredient (API) suppliers "artificially inflate" the "Average Wholesale Price (AWP) of the raw material drugs used in these creams by 1,000%, but will sell the API's to compounding pharmacies for a tenth of the AWP.
- Compounding Pharmacies bill insurance at the AWP (often $2,000 - $3,000 for a month's supply of transdermal cream), but get reimbursed by the insurance company at about 80% of billed charges. The insurance company may think they "negotiated a good deal", but in reality, they got scammed.
- The compounding pharmacy makes so much profit ($1,000 - $1,500 per prescription per month) that they can afford to pay outrageous commissions tomtheir sales reps (and sometimes, kickbacks to the prescriber).
Kenneth N. Woliner, M.D.
www.holisticfamilymed.com
AVMA announces that American Association of Bovine Practitioners have developed guide for proper oversight of drugs use in cattle
Cattle veterinarians develop guide on drug oversight
The AABP published in November 2013 the two-page guide on veterinarian-client-patient relationship practices that the organization endorses and that exceed regulatory requirements.
For example, the guide indicates veterinarians or veterinary practices should have written agreements that identify the veterinarian who is accountable for drug administration on a farm as well as who is responsible for duties such as drug inventory maintenance.
The guide, “Establishing and Maintaining the Veterinarian-Client-Patient Relationship in Bovine Practice,” is available here.
The document also describes AABP-endorsed practices of establishing a veterinarian of record, clarifying relationships among veterinarians and consultants on farms, providing treatment protocols, maintaining treatment records, and prescribing drugs.
The guide is intended to help veterinarians ensure they and their clients communicate and keep records in ways that ensure pharmaceuticals are used in a responsible manner, Dr. Keith Sterner of Ionia, Mich., said in an AABP announcement. Dr. Sterner was chair of the AABP task force that created the guidelines.
The AABP also is developing cattle well-being guidelines, the announcement states.
Posted Dec. 30, 2013
A guide from the American Association of Bovine Practitioners is intended
to help veterinarians ensure they establish proper oversight for drug use in
cattle.
The AABP published in November 2013 the two-page guide on veterinarian-client-patient relationship practices that the organization endorses and that exceed regulatory requirements.
For example, the guide indicates veterinarians or veterinary practices should have written agreements that identify the veterinarian who is accountable for drug administration on a farm as well as who is responsible for duties such as drug inventory maintenance.
The guide, “Establishing and Maintaining the Veterinarian-Client-Patient Relationship in Bovine Practice,” is available here.
The document also describes AABP-endorsed practices of establishing a veterinarian of record, clarifying relationships among veterinarians and consultants on farms, providing treatment protocols, maintaining treatment records, and prescribing drugs.
The guide is intended to help veterinarians ensure they and their clients communicate and keep records in ways that ensure pharmaceuticals are used in a responsible manner, Dr. Keith Sterner of Ionia, Mich., said in an AABP announcement. Dr. Sterner was chair of the AABP task force that created the guidelines.
The AABP also is developing cattle well-being guidelines, the announcement states.
quoted from here
Major Changes in State of Washington Regarding Compounding Rules in 2013
The Washington State Legislature has passed a law stating that all compounding done within the state must comply with
United States Pharmacopeia (USP) standards for compounding. The Washington
State Pharmacy Quality Assurance Commission (previously known as the Board of
Pharmacy), is currently writing rules based on the standards. Rumor has it state
pharmacy inspectors are already beginning to use USP standards in surveying
compounding pharmacies. William E. Fassett, PhD, RPh, FAPha, Professor of Pharmacy Law and Ethics at Washington State University-Spokane has a great summary of some of the changes effecting pharmacies in his Law Matters June 2013 Newsletter found here. He explains that the Board of Pharmacy is now the Pharmacy Quality Assurance Commission (HB 1609) and that commission typically have a larger number of members and in this case the increase is from 7 to 15 members. The commission will have 10 pharmacists, 1 pharmacy technician and 4 public members. Dr. Fassett summaries the new law regarding compounding as follows:
Compounding of drugs for office use, incorporation of USP <795> and <797> (HB 1800) – Effective
May 7, 2013
This statute amends the definition of “manufacture” in the Legend Drug Act to include distribution of products compounded by a licensed pharmacy to other state licensed persons for subsequent resale, “unless a specific product item has approval of the board.” However, “manufacture” does not include: (1) compounding by a licensed pharmacy pursuant to an order of a licensed practitioner for use in the practitioner’s practice by
administration to his or her patients; (2) repackaging of a commercially‐available medication by a pharmacy in
“small, reasonable quantities” for a practitioner’s office use; (3) distribution of products compounded by a licensed pharmacy to “other appropriately licensed entities under common ownership or control of the facility in which the compounding takes place;” or (4) delivery of finished and appropriately labeled products compounded pursuant to a prescription to “alternate delivery locations, other than the patient’s residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient.”
The statute also incorporates USP chapters on compounding into state law, by amending RCW 18.64.270 to read “Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products.”
New Texas Board of Pharmacy Rules Relating to Compounding Effective December 10, 2013 unless noted otherwise
SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)
§291.33 Operational Standards, §291.36 Pharmacies Compounding Sterile Preparations (Class A-S)
The amendments to §291.33 clarify that Class A pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class A-S pharmacy license. New §291.36 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER D. INSTITUTIONAL PHARMACY (CLASS C)
§291.74 Operational Standards, §291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center, §291.77 Pharmacies Compounding Sterile Preparations (Class C-S)
The amendments to §291.74 and §291.76 clarify that Class C pharmacies will no longer be able to compound sterile preparations after August 1, 2014, unless the pharmacy obtains a Class C-S pharmacy license. New §291.77 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER F. NON-RESIDENT PHARMACY (CLASS E)
§291.104 Operational Standards, §291.105 Records, §291.106 Pharmacies Compounding Sterile Preparations (Class E-S)
The amendments to §291.104 clarify that Class E pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class E-S pharmacy license. The amendments to §291.105 add requirements for auto-refill programs. New §291.106 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the TSBP appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
§291.133 Pharmacies Compounding Sterile Preparations
New §291.133 outlines operating standards for pharmacies that compound sterile preparations, implements the recommendations of the TSBP appointed Task Force on Compounding (Task Force), incorporates provisions included in the United States Pharmacopeia (USP) General Chapter 797, and implements Senate Bill 1100 passed during the 83rd Regular Session of the Texas Legislature regarding pharmacies compounding sterile preparations.
quoted from here
§291.33 Operational Standards, §291.36 Pharmacies Compounding Sterile Preparations (Class A-S)
The amendments to §291.33 clarify that Class A pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class A-S pharmacy license. New §291.36 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER D. INSTITUTIONAL PHARMACY (CLASS C)
§291.74 Operational Standards, §291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center, §291.77 Pharmacies Compounding Sterile Preparations (Class C-S)
The amendments to §291.74 and §291.76 clarify that Class C pharmacies will no longer be able to compound sterile preparations after August 1, 2014, unless the pharmacy obtains a Class C-S pharmacy license. New §291.77 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER F. NON-RESIDENT PHARMACY (CLASS E)
§291.104 Operational Standards, §291.105 Records, §291.106 Pharmacies Compounding Sterile Preparations (Class E-S)
The amendments to §291.104 clarify that Class E pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class E-S pharmacy license. The amendments to §291.105 add requirements for auto-refill programs. New §291.106 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the TSBP appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
§291.133 Pharmacies Compounding Sterile Preparations
New §291.133 outlines operating standards for pharmacies that compound sterile preparations, implements the recommendations of the TSBP appointed Task Force on Compounding (Task Force), incorporates provisions included in the United States Pharmacopeia (USP) General Chapter 797, and implements Senate Bill 1100 passed during the 83rd Regular Session of the Texas Legislature regarding pharmacies compounding sterile preparations.
quoted from here
Update on Texas Board of Pharmacy Rules that Became Effective December 10, 2013 and proposed rules being considered for adoption
The Board met on November 4-5, 2013, in Austin, Texas. To view the meeting agenda and additional materials, click here. Rules adopted at the November Board meeting were published as adopted in the December 6, 2013, issue of the Texas Register and became effective December 10, 2013. Rules proposed at the November Board meeting are posted in the December 13, 2013, issues of the Texas Register and are available for public comment until January 24, 2014. The proposed rules will be considered for adoption at the next TSBP board meeting on February 11, 2014. You may view a summary of the adopted and proposed rules here. You may also view the adopted and proposed rule language from the November Board Meeting agenda. Please note underlined language is new language and language that is being deleted is lined out. All other language is currently in the rules and is not being changed.
quoted from Texas Board of Pharmacy Newsletter
quoted from Texas Board of Pharmacy Newsletter
The Worst Scientific Mistakes, Missteps and Misdeeds Seeded by Colin Klein
Science is not immune to the foibles that plague ordinary, not-parked-at-a-lab-bench citizens. But mistakes made in a lab can be dangerous, and even deadly. Misleading or faulty scientific reports can send other scientists astray, wasting years of time and hard-earned research grants. Badly designed apps and poorly analyzed data can help lose a presidential election.
Every year, a number of scientists are caught in various forms of misbehavior. Now, some scientistseven study the misdeeds of others. Here are some of the most notable examples of science-related errors, missteps and dishonesty in 2012, ranging from the mildly amusing to the truly deadly.
Pharmaceutical Distributor Contaminates Drug, Causes Outbreak
continue to read here
Every year, a number of scientists are caught in various forms of misbehavior. Now, some scientistseven study the misdeeds of others. Here are some of the most notable examples of science-related errors, missteps and dishonesty in 2012, ranging from the mildly amusing to the truly deadly.
Pharmaceutical Distributor Contaminates Drug, Causes Outbreak
continue to read here
Monday, December 30, 2013
1099 sales rep opening for compound pain medications
1099 Pharmaceutical Sales Rep or Medical Device
CityWide SolutionsRX - Greater Minneapolis-St. Paul Area
Posted 13 days ago
Job description
We are looking for several Experienced Sales Reps. These positions are best worked in
addition with your current employment (completely confidential). These are 1099
positions and the commissions are lucrative.
If you have Pharmaceutical Sales Experience and if you know doctors in pain
management, or/and in orthopedics, sports medicine, rheumatology, pediatrics,
family practitioners, internists, podiatrists, plastic surgeons, and
vascular/diabetes, we would like to talk to you about selling our compound pain
creams.
Disease States covered: anti-inflammatory, neuropathic pain,
combination pain, osteoarthritis, joint or musculoskeletal pain, ect.
You are paid on new AND re-filled scripts giving you monthly
passive income. Re-filled scripts pay out 100% of original commission. The
Average commission Per Script is $200-$450. Commissions are paid out monthly.
quoted from here
addition with your current employment (completely confidential). These are 1099
positions and the commissions are lucrative.
If you have Pharmaceutical Sales Experience and if you know doctors in pain
management, or/and in orthopedics, sports medicine, rheumatology, pediatrics,
family practitioners, internists, podiatrists, plastic surgeons, and
vascular/diabetes, we would like to talk to you about selling our compound pain
creams.
Disease States covered: anti-inflammatory, neuropathic pain,
combination pain, osteoarthritis, joint or musculoskeletal pain, ect.
You are paid on new AND re-filled scripts giving you monthly
passive income. Re-filled scripts pay out 100% of original commission. The
Average commission Per Script is $200-$450. Commissions are paid out monthly.
quoted from here
Virginia Veterinary Medical Association 2014 Conference
HERE - Virginia Veterinary Medical Association
www.vvma.org/MediaArchive/PDF/.../Final%202014%20brochure.pdf
Dec 6, 2013 - followed by a meeting with the Board of Veterinary Medicine to discuss .... Assistants and the VA Board of Pharmacy, Compounding Issues. Friday .... Leader, Iowa State University College of. Veterinary Medicine. Ames, IA. Christine .... completed International Health Certificates and Certificates of Veterinary Inspection.
Kudos to Leiter's Compounding Pharmacy for publishing its Quality Control Report
Quality Control Report - Leiter's Compounding Pharmacy
www.leiterrx.com/wp-content/.../QA-Documents_REV9_121713.pdf
Dec 16, 2013 - Cod,Er the fi.rrn nCrnC heirebn ia tipensed sl,,,,lh. ' .... Critical Point: Training for sterile compounding technicians and pharmacists include on-‐line modules as ... Required Reading: Board of Pharmacy Title 16, Section 1751 (State Regulations)Prescription Law Changes That Impact Veterinary Practices--Arizona, Florida, New Mexico, and Virginia Clarify in office use rules
A New Jersey bill was introduced to require veterinarians to provide written
prescriptions as well as oral and written notification that the prescription
item may be obtained from sources other than the veterinarian. The Oregon
Veterinary Medical Examining Board is considering regulations to require
veterinarians to provide a written prescription to a client upon request.
Similar legislation was not introduced in Congress in 2013. The Federal Trade
Commission has not yet issued a report or findings after holding a workshop on
this topic in the fall of 2012.
The State Agricultural and Rural Leaders, a national group of state legislators, endorsed a resolution supporting The Veterinary Medicine Mobility Act of 2013, currently pending in the U.S. Congress. The legislation aims to change federal law that some DEA offices have interpreted as prohibiting veterinarians from transporting controlled substances to administer and treat patients outside of a registered location. The amendment would clarify that a veterinarian may transport controlled substances outside a registered location (i.e., clinic, hospital, office or clinician's home) to provide comprehensive veterinary care and to protect animal health and welfare.
Arizona, Florida, New Mexico, Texas and Virginia issued rules clarifying in-office use or dispensing of compounded products. The newly-passed federal law, the Drug Quality and Security Act, only regulates compounding pharmacies that produce drugs for human medicine. However, some of the compounding pharmacies that are subject to the law also compound drugs for veterinary medicine and will be impacted.
Concluding a five-year study, a Kansas legislative task force reached the conclusion that veterinarians should not be included in the state's prescription monitoring program. Similarly, Maryland, North Carolina, Tennessee and Wisconsin have decided to exempt licensed veterinarians from the requirements of their state programs, either completely or in certain conditions. Connecticut, Louisiana and Rhode Island made changes or expanded their prescription monitoring programs, which include veterinarians as mandated reporters. The Washington State Department of Health issued rules to implement statutory law that provides alternative, less-burdensome reporting requirements for veterinarians.
quoted from the AVMA
The State Agricultural and Rural Leaders, a national group of state legislators, endorsed a resolution supporting The Veterinary Medicine Mobility Act of 2013, currently pending in the U.S. Congress. The legislation aims to change federal law that some DEA offices have interpreted as prohibiting veterinarians from transporting controlled substances to administer and treat patients outside of a registered location. The amendment would clarify that a veterinarian may transport controlled substances outside a registered location (i.e., clinic, hospital, office or clinician's home) to provide comprehensive veterinary care and to protect animal health and welfare.
Arizona, Florida, New Mexico, Texas and Virginia issued rules clarifying in-office use or dispensing of compounded products. The newly-passed federal law, the Drug Quality and Security Act, only regulates compounding pharmacies that produce drugs for human medicine. However, some of the compounding pharmacies that are subject to the law also compound drugs for veterinary medicine and will be impacted.
Concluding a five-year study, a Kansas legislative task force reached the conclusion that veterinarians should not be included in the state's prescription monitoring program. Similarly, Maryland, North Carolina, Tennessee and Wisconsin have decided to exempt licensed veterinarians from the requirements of their state programs, either completely or in certain conditions. Connecticut, Louisiana and Rhode Island made changes or expanded their prescription monitoring programs, which include veterinarians as mandated reporters. The Washington State Department of Health issued rules to implement statutory law that provides alternative, less-burdensome reporting requirements for veterinarians.
quoted from the AVMA
Iowa and New Jersey Nearing End of Compounding Inpsection Program
Iowa and New Jersey
Inspection Programs
Nearing Completion
The Iowa Board of
Pharmacy partnered with
member boards and NABP
to conduct inspections of
all its nonresident pharmacies
including those
dispensing compounded
drugs to the state following
the 2012 multistate fungal
meningitis outbreak linked
to contaminated injectable
drugs compounded by the
New England Compounding
Center. NABP surveyors
began conducting pharmacy
inspections on behalf of
the Iowa Board of Pharmacy
in December 2012,
and inspections have been
completed at an average rate
of 15 to 20 inspections per
week. To date, more than
500 nonresident pharmacies
that dispense drugs to
patients in Iowa have been
inspected. The program is
projected to be completed
by mid-December 2013.
Similarly, the state
of New Jersey requested
NABP’s assistance in conducting
inspections of pharmacies
engaged in compounding
within the state.
NABP is assisting the New
Jersey Division of Consumer
Affairs (Division) with
planned inspections, under
a contract with the Division
and state’s Attorney General
Jeffrey S. Chiesa. Surveyors
began inspections in July
2013 and are expected to
complete them in the spring
of 2014.
In addition to supporting
these state efforts to expand
inspections, the programs
provided opportunities
for collaboration among
member boards and NABP.
NABP surveyors and board
inspectors developed strong
working relationships that
enabled them to learn from
shared experiences of conducting
inspections.
quoted from here
USP 797 Standards Powerpoint Lecture
USP <797> Standards – Pharmaceutical Compounding Sterile
courses.washington.edu/pharm504/USP797Lecture.ppt
Third Question of the Day December 30, 2013 When a pharmacy advertises testing for hormone levels, then suggest the formula for the hormone replacements and then tells patients to either take the information to their doctor or refers patients to a doctor, what at the civil and criminal legal issues with this fact pattern? So fact pattern but it involves pain management?
For those who miss the 4 part series done by Fred Hiers here are links to all the aticles he did on compounding recently
New pharmacy safeguards: Real change or window dressing?
Published December 23, 2013The Florida Board of Pharmacy wants the public's trust.
State inspections found lacking for pharmacies
Published December 22, 2013After the NECC debacle, some states, including Florida, began taking a look at what their drug-making pharmacies were doing.
Changing times don't bring changing rules for compounders
Published December 22, 2013Corner drugstores or drug manufacturers? That is the central question driving the debate over pharmaceutical compounders.
For nation's drug supply, a mixture of regulations
Published December 21, 2013The Marion Pain Management Center in Ocala had been running a few minutes behind when Roseann Fusco walked in, but that was little concern.
FDA Moves Quickly to Implement Compounding Provisions of DQSA
FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27.
On December 4, a week after the signing, FDA issued three draft guidances and three companion Federal Register (FR) notices related to the implementation of the compounding provisions of the act.
The 60-day comment period on the three guidances extends until February 3. Comments on the FR notices are due by March 4.
The speed at which the agency is moving in the act’s implementation reflects the central place that compounding operations have occupied on FDA’s inspection and health protection radar screen since the fall 2012 meningitis outbreak caused by fungal-contaminated sterile methylpredisone produced by NECC (IPQ Special Report November, 2012).
The association of pharma products with the quality and public health problems created by compounding pharmacies and other handlers of their products downstream in the distribution chain is also of very real concern to the industry – both in terms of brand-name tarnishing, but also in their potential involvement in recalls and other follow up legal and enforcement actions.
[The story continues for subscribers beginning on page 2. Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes (rhodes@IPQpubs.com). For subscription/license information, click here.]
On December 4, a week after the signing, FDA issued three draft guidances and three companion Federal Register (FR) notices related to the implementation of the compounding provisions of the act.
The three draft guidances cover: ● overarching rules for what constitutes pharmacy compounding and how enforcement for violations may be applied ● a definition of a new category of compounder created by the DQSA – “an outsourcing facility” – and the registration requirements, and ● interim requirements for ongoing reporting of information to FDA by the outsourced facilities on their products and services.The FR notices explain that FDA will be producing listings of bulk drug substances used in pharmacy compounding and products made from those substances as well as a list of “difficult-to-compound” products. The agency is requesting that industry nominate candidates for the lists. Included in the FR notices are the information required for nominations to be considered as well as a template for the submission of candidates for the difficult to compound list.
The 60-day comment period on the three guidances extends until February 3. Comments on the FR notices are due by March 4.
The speed at which the agency is moving in the act’s implementation reflects the central place that compounding operations have occupied on FDA’s inspection and health protection radar screen since the fall 2012 meningitis outbreak caused by fungal-contaminated sterile methylpredisone produced by NECC (IPQ Special Report November, 2012).
Pharmaceutical manufacturers are impacted by what is happening in the compounding arena and should be paying close attention to how the new act is being implemented.A longstanding issue is the line between compounding and unapproved drugs, which may compete with products that have to meet stringent approval and inspection demands. The drug shortage issue is also at play in that pharmacy compounders step in to fill perceived market gaps – again, often with unclear authority to do so.
The association of pharma products with the quality and public health problems created by compounding pharmacies and other handlers of their products downstream in the distribution chain is also of very real concern to the industry – both in terms of brand-name tarnishing, but also in their potential involvement in recalls and other follow up legal and enforcement actions.
[The story continues for subscribers beginning on page 2. Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes (rhodes@IPQpubs.com). For subscription/license information, click here.]
Texas Board of Pharmacy officer PIC training
Pharmacist-in-Charge Training
Powered by GoToTraining®
Are you a new pharmacist-in-charge (PIC) or just need a refresher on the requirements and responsibilities as PIC? The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webinar on Thursday, January 16, 2014, at 10:00 a.m. This program is intended for individuals interested in learning about the responsibilities of the PIC, primarily in community (Class A) pharmacy settings. This program will also be held on the following dates: April 9, 2014 at 10:00 a.m. https://student.gototraining.com/r/6856480098723933952 July 15, 2014, at 10:00 a.m. https://student.gototraining.com/r/4500919372725489664 October 9, 2014 at 10:00 a.m. https://student.gototraining.com/r/7461886594140228608 Each webinar will cover the same information; please only register for one program.
Texas Board of Pharmacy is hosting free one-hour webcase on rule changes and most common deficiencies during inspection
Texas Pharmacy Laws and Rules Update
The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webcast on Thursday, February 27, 2014, at 2:00 p.m. The program will review recent changes to pharmacy rules; and review the most common deficiencies found during inspections of pharmacies. One hour of continuing education (CE) credit approved by TSBP is available for attendees of the program.
Georgia Board of Pharmacy December 2013 Public Board Actions List
December 2013 Public Board Actions List
Georgia Board of Pharmacy
2 Peachtree Street
36th Floor
Atlanta, GA 30303
PH: (404) 651-8000
FX: (678) 717-6694
Licensee’s Name: Number: Profession: Type of Action Taken:
Alley, Lynda RPH012282 Pharmacist Approve public consent order
Champine, Jeffrey RPH025342 Pharmacist Approve order for reinstatement
Duluth Rexall Pharmacy Inc. PHRE002924 Retail Pharmacy Approve public consent order
quoted from here
South Dakota Board of Pharmacy Minutes from December 6, 2013 Meeting
Friday, December 6, 2013, 9:00 A.M.
Avera Prairie Center Building - Presentation Room; 1000 E. 23rd St., Sioux Falls, SD
Others Present: Andrea Darr, Avera ePharmacy; Sue Schaefer, SD Pharmacist’s Association; Dennis Hedge, SDSU College of Pharmacy; Lora VanDyke, Pharmacy Specialties, Inc.; Scott Setzepfandt, Genentech; Bill Ladwig, Lewis Drug; and Tom Johnson, Avera McKennan Pharmacy
Avera Prairie Center Building - Presentation Room; 1000 E. 23rd St., Sioux Falls, SD
Members Present: Lisa Rave, Jeff Nielsen, Diane Dady, and Lenny Petrik
Staff Present: Executive Director Randy Jones; PDMP Director Kari Shanard-Koenders; Inspectors Gary Karel; and Senior Secretary Rita SchulzOthers Present: Andrea Darr, Avera ePharmacy; Sue Schaefer, SD Pharmacist’s Association; Dennis Hedge, SDSU College of Pharmacy; Lora VanDyke, Pharmacy Specialties, Inc.; Scott Setzepfandt, Genentech; Bill Ladwig, Lewis Drug; and Tom Johnson, Avera McKennan Pharmacy
Present by Phone: Arlene Ham-Burr (Board Member) and Paula Stotz (Staff Member)
The meeting was called to order by Lisa Rave at 9:00 a.m. with introductions of Board members, staff, and others in attendance.
A. Minutes
Jeff Nielsen moved for approval of the September 12th, 2013 meeting minutes. Seconded by Diane Dady. Motion carried.
B. Financial Report
The Board Financial Report was reviewed and approved. Executive Director Randy Jones provided an overview and highlighted remaining balance.
The status of salaries in the PDMP program due to the government shut-down was discussed along with additional information needed to acquire grant funds awarded.
C. Staff Reports
1.
| Employee Update: |
| Director Jones requested the minutes reflect the passing of inspector Ron Johnson on October 25th. A brief conversation was held in regards to the open position which will be discussed at a future Board meeting. | |
2.
| Inspector Reports |
| Inspector: Gary Karel | |
Education to PICs on the following:
Discussion introduced by Bill Ladwig was held on spot inventory checks, cameras, and other security precautions in pharmacies. Also discussed was Medicaid D and prescription storage.
| |
| Inspector: Paula Stotz | |
| |
| PDMP Report: Kari Shanard– Koenders-PDMP Director | |
| |
3.
| Statistical Reports |
| Licensing activities were reviewed and discussion followed. |
D. Approvals – 60% now have automation and this number will increase. Kessler’s Pharmacy and Medicine Shoppe Advanced Care now have letter reflecting approvals but approvals had been in place for some time.
1.
2.
3.
4.
5.
|
Regional Health; AMDD Revised
Kessler’s Pharmacy; Aberdeen – AMDD*
Regional Outpatient Pharmacy; Rapid City – AMDD Revised
Medicine Shoppe Advanced Care; Rapid City – AMDD*
Randall Pharmacy; Redfield – Credit Return of Unit Dose
|
E. Variances – 3:1 ratio variances are increasing. Discussion was held on this ratio and further discussion will be put on Board’s future agenda.
1.
2.
3.
4.
|
Wal-Mart; Brookings - 3:1 Technician Ratio
Hy-Vee (S. Minn); Sioux Falls – 3:1 Technician Ratio
Omnicare; Sioux Falls – 3:1 Technician Ratio
Wal-Mart; Spearfish – 3:1 Technician Ration (renewal)
|
F. Complaints, Investigations, Disciplinary Actions, Loss / Theft Reports – Explanation of Complaint was provided and followed by discussion.
1.
2.
3.
4.
5.
6.
7.
8.
|
Medicap Pharmacy; Rapid City – Complaint
Wal-Mart Pharmacy; Rapid City – Compliant
Haisch Pharmacy; Canton – Complaint
Family Pharmacy (Clinic); Mobridge – Loss / Theft
Family Pharmacy (Downtown); Mobridge – Loss / Theft
Hy-Vee Pharmacy; Watertown – Loss / Theft
Murdy Pharmacy; Aberdeen – Loss / Theft
Omnicare; Loss/Theft
|
Iowa Board of Pharmacy has formed a Pharmacy Compounding Task Force
Pharmacy Compounding Task Force
The Iowa Board of Pharmacy and the Iowa Pharmacy Association
have established a new task force to review Iowa laws
and rules pertaining to pharmacy compounding, the licensing
and regulation of nonresident pharmacies, and drug wholesalers.
The following individuals have agreed to participate: DeeAnn
Wedemeyer-Oleson, Lucinda Harms, Gayle Mayer, Alisha
Eggers, Jack Kampf, Jim Ponto, Ron Hartman, Nic Mastascusa,
Cindy Marek, Sue Hoffman, Tammy Sharp-Becker, Karmen
Jorgenson, Manda Johnson, James Van Winkle, Karen Merrill,
Ken Saunders, Ed Maier, and Sharon Meyer. The task force held
its first meeting on November 12, 2013. It will make recommendations
to the Board sometime during the first half of 2014.
How many compounding pharmacies or pharmacists follow this Iowa rule regarding Advertising Compounding Services?
Iowa Board of Pharmacy Rule 20.3(4)(c). Advertising compounding services. A compounding pharmacy or pharmacist may advertise or otherwise promote the fact that the pharmacy or pharmacist provides prescription drug compounding services. A compounding pharmacy or pharmacist shall not make a claim, assertion, or inference of professional superiority in the compounding of drug products that cannot be substantiated. All advertisements shall meet the requirements contained in rule 657—8.12(126,147).
Monday, December 30, 2013 Drug Shortage Report blog: Bennett Burr Power Grab--the transfer of authority from states to the federal government
When politicians start talking about “bi-partisan cooperation,” smart citizens get nervous. It usually means another transfer of freedom and taxes to the federal government at the expense of individuals, families, localities, and states.
Case in point: a Denver Post op-ed by two U.S. Senators (or their staffs) on their latest “bipartisan” deal. The Senators are Michael Bennett (D.-Colo.) and Richard Burr (R.-N.C.). The op-ed is pure political blather, a haze of almost incomprehensible feel-good rhetoric. But the upshot is this: The two distinguished solons are very proud of themselves for managing yet another transfer of authority from the states to the federal government.
continue to read here
Antibiotic Use in Animals Under Fire--Every day, Americans use some 51 tons of antibotics
by Michael Smith, North American Correspondent, MedPage Today
But only about a fifth of that is to treat human illness. Most of the rest is given to livestock -- and not because the animals are sick. Instead -- despite increasing antibiotic resistance among pathogens -- the drugs are used for what the FDA calls "production purposes": to help animals gain weight more rapidly or to improve feed efficiency.
Those uses, the agency said in a guidance issued in December, are no longer "judicious" and should be stopped.
Last year, the FDA asked farmers voluntarily to agree only to use antibiotics to promote animal health and only then if the use is approved by a veterinarian.
In the December guidance, the agency asked drug-makers to take production uses off antibiotic labels within 3 years
continue to read here
Sunday, December 29, 2013
California Board of Pharmacy Disciplinary Action--Kudos for already issued cease and desist against Abrams Royal Pharmacy--also action against several others including Westside Pharmacy
Abrams Royal Pharmacy, NSC 99466
Dallas, TX
Cease and desist immediately from compounding sterile injectable drug products.
Decision effective 12/23/2013.
View the Decision
De Soto Pharmacy, PHY 32271, Administrative Case AC 3662
Canoga Park, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 11/27/2013.
View the Decision
De Soto Pharmacy, PHY 50809, Statement of Issues Case SI 4311
Canoga Park, CA
Through a disciplinary action of the board the license is issued, and the license is subject to a Letter of Public Reprimand.
Decision effective 11/27/2013.
View the Decision
Fountain Valley Cancer Center Pharmacy, PHY 43274, LSC 99020, Administrative Case AC 4551
Fountain Valley, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three months or by January 1, 2014, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Half Moon Bay Pharmacy, PHY 44400, Administrative Case AC 4349
Half Moon Bay, CA
Through a disciplinary action of the board, the license is subject to a letter of public reprimand.
Decision effective 10/9/2013.
View the Decision
RX Care Pharmacy, PHY 46138, Administrative Case AC 3254
Torrance, CA
Through a disciplinary action of the board, the license is revoked and canceled and the right to practice or operate has ended. President Michael Voldman is prohibited from owning any board licensed entity.
Decision effective 11/27/2013.
View the Decision
UPAS Pharmacy, PHY 36112, Administrative Case AC 4190
San Diego, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed, and the license shall continue on probation for an additional four years. The terms and conditions of probation include posting a notice of probation.
Decision effective 10/7/2013.
View the Decision
Walgreens No 06683, PHY 46263, Administrative Case AC 3695
Visalia, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three years. The terms and conditions of probation include posting a notice of probation.
Decision effective 11/12/2013.
View the Decision
Westlake Care Pharmacy, PHY 49290, Administrative Case AC 4231
Westlake Village, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for sixty days or by December 1, 2013, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Westside Pharmacy, PHY 15178, Administrative Case AC 4385
Fresno, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 12/17/2013.
View the Decision
Dallas, TX
Cease and desist immediately from compounding sterile injectable drug products.
Decision effective 12/23/2013.
View the Decision
De Soto Pharmacy, PHY 32271, Administrative Case AC 3662
Canoga Park, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 11/27/2013.
View the Decision
De Soto Pharmacy, PHY 50809, Statement of Issues Case SI 4311
Canoga Park, CA
Through a disciplinary action of the board the license is issued, and the license is subject to a Letter of Public Reprimand.
Decision effective 11/27/2013.
View the Decision
Fountain Valley Cancer Center Pharmacy, PHY 43274, LSC 99020, Administrative Case AC 4551
Fountain Valley, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three months or by January 1, 2014, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Half Moon Bay Pharmacy, PHY 44400, Administrative Case AC 4349
Half Moon Bay, CA
Through a disciplinary action of the board, the license is subject to a letter of public reprimand.
Decision effective 10/9/2013.
View the Decision
RX Care Pharmacy, PHY 46138, Administrative Case AC 3254
Torrance, CA
Through a disciplinary action of the board, the license is revoked and canceled and the right to practice or operate has ended. President Michael Voldman is prohibited from owning any board licensed entity.
Decision effective 11/27/2013.
View the Decision
UPAS Pharmacy, PHY 36112, Administrative Case AC 4190
San Diego, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed, and the license shall continue on probation for an additional four years. The terms and conditions of probation include posting a notice of probation.
Decision effective 10/7/2013.
View the Decision
Walgreens No 06683, PHY 46263, Administrative Case AC 3695
Visalia, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three years. The terms and conditions of probation include posting a notice of probation.
Decision effective 11/12/2013.
View the Decision
Westlake Care Pharmacy, PHY 49290, Administrative Case AC 4231
Westlake Village, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for sixty days or by December 1, 2013, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Westside Pharmacy, PHY 15178, Administrative Case AC 4385
Fresno, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 12/17/2013.
View the Decision
Industry Uncertain What Effect New Law Will Have
By FRED HIERS
HALIFAX MEDIA SERVICES
Published: Sunday, December 29, 2013 at 10:47 p.m.
Last Modified: Sunday, December 29, 2013 at 10:47 p.m.
It was too much for federal regulators to ignore and the public to tolerate: 64 people dead after a Massachusetts pharmacy shipped contaminated drugs to 23 states.
The New England Compounding Center in Massachusetts had already been in hot water with both federal and state regulators for a decade leading up to the debacle. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business down, much less allowed it to pump thousands of doses of fungal-contaminated drugs into the patient stream.
continue to read here
Unknown Risks of Pharmacy-Compounded Drugs
Larry D. Sasich, PharmD, MPH, Chair;
- Sana R. Sukkari, BScPharm, MPhil, Assistant Professor
+ Author Affiliations
To the Editor: In August 2006, the United States Food and Drug Administration (FDA) announced that warning letters had been issued to three pharmacies that were producing and distributing thousands of doses of compounded inhalation medications not approved by the FDA.1 These inhalation medications were used to treat patients with such respiratory diseases as asthma, bronchitis, cystic fibrosis, and emphysema.1
Pharmacy compounding traditionally involves such practices as manipulating an FDA-approved dosage form, such as a tablet or capsule, to prepare a solution or suspension for individual patients who have difficulties in swallowing.2 Traditional pharmacy compounding may also involve preparing an FDA-approved medication excluding a specific ingredient to which an individual patient may have a hypersensitivity.2 The FDA permits such traditional practices by pharmacies.
By contrast, nontraditional practices of pharmacy compounding—such as those that prompted the FDA warnings—include the mass production of drug combinations from bulk substances that are sometimes of unknown origin.1 These drug combinations may be exact copies or slightly modified versions of FDA-approved pharmaceutical products.2 The FDA has expressed concern that such nontraditional practices of pharmacy compounding may expose patients to unnecessary health risks.1,2
The true extent of nontraditional pharmacy compounding in the United States is unknown. However, the FDA and many state public health authorities have expressed serious concerns about quality and safety issues regarding compounded inhalation drugs.2,3 For example, minutes from the May 2007 meeting of the Ohio State Board of Pharmacy reveal disciplinary action against one pharmacy-compounding facility.3 According to our calculations based on numbers provided in these minutes, between July 2005 and November 2005, the pharmacy in question compounded and dispensed 119 prescriptions for an estimated 7530 doses of inhalation medications, including five different drug-combination products.3 Two of the five compounded products were identical to FDA-approved medications, while three were unapproved combinations.3 Of the seven drug substances that were used to produce the combinations, five were available as FDA-approved inhalation medications, while two (betamethasone and dexamethasone) were not.3
continue to read hereJustice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
Justice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
Second Largest Annual Recovery in History Whistleblower Lawsuits Soar to 752
The Justice Department secured $3. 8 billion in settlements and judgments from civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2013, Assistant Attorney General for the Civil Division Stuart F. Delery announced today. This dollar amount, which is the second largest annual recovery of its type in history, brings total recoveries under the False Claims Act since January 2009 to $ 17 billion – nearly half the total recoveries since the Act was amended 27 years ago in 1986.
The Justice Department’s fiscal year 2013 efforts recovered more than $3 billion for the fourth year in a row and are surpassed only by last year’s nearly $5 billion in recoveries. As in previous years, the largest recoveries related to health care fraud, which reached $2. 6 billion. Procurement fraud (related primarily to defense contracts) accounted for another $ 890 million – a record in that area.
“It has been another banner year for civil fraud recoveries, but more importantly, it has been a great year for the taxpayer and for the millions of Americans, state agencies and organizations that benefit from government programs and contracts,” said Assistant Attorney General Delery. “The $3. 8 billion in federal False Claims Act recoveries in fiscal year 2013, plus another $443 million in recoveries for state Medicaid programs, restores scarce taxpayer dollars to federal and state governments. The government’s success in these cases is also a strong deterrent to others who would misuse public funds, which means government programs designed to keep us safer, healthier and economically more prosperous can do so without the corrosive effects of fraud and false claims.”
Southern District of Texas Prosecutes Doctor for introducing misbranded drugs
LAREDO, Texas – Eduardo Miranda M.D., 55, of Laredo, has pleaded guilty to one count of introducing misbranded drugs into the country, announced United States Attorney Kenneth Magidson.
From October 2007 through January 2009, Miranda, a doctor who specializes in treating patients with cancer, ordered cancer drugs from a pharmacy called QSP, based in Canada. These drugs were not approved for distribution or use in the U.S. and did not bear adequate labeling for use. Some of the drugs had instructions and labeling in other languages. QSP was also not an authorized distributor or a retailer of these drugs in Canada.
Miranda then used these drugs interchangeably with Food and Drug Administration (FDA) - approved versions on his patients and filed insurance claims with Medicaid, Medicare and Blue Cross/Blue Shield of Texas as if he were using lawfully-approved versions.
From October 2007 through January 2009, Miranda, a doctor who specializes in treating patients with cancer, ordered cancer drugs from a pharmacy called QSP, based in Canada. These drugs were not approved for distribution or use in the U.S. and did not bear adequate labeling for use. Some of the drugs had instructions and labeling in other languages. QSP was also not an authorized distributor or a retailer of these drugs in Canada.
Miranda then used these drugs interchangeably with Food and Drug Administration (FDA) - approved versions on his patients and filed insurance claims with Medicaid, Medicare and Blue Cross/Blue Shield of Texas as if he were using lawfully-approved versions.
As part of the plea agreement, Miranda has agreed to pay back the reimbursement he had received while using non-approved versions - more than $1 million.
He was permitted to remain on bond pending his sentencing, which will be set at a later date. At that time, he will face up to a year in federal prison and/or a possible $100,000 fine.
The case was investigated by the FDA and Texas Attorney General’s Office-Medicaid Fraud Control Unit and prosecuted by Assistant United States Attorneys (AUSA) Raul Guerra and Sonah Lee and former AUSAs Sam Louis, Diana Song and D.J. Young.
The case was investigated by the FDA and Texas Attorney General’s Office-Medicaid Fraud Control Unit and prosecuted by Assistant United States Attorneys (AUSA) Raul Guerra and Sonah Lee and former AUSAs Sam Louis, Diana Song and D.J. Young.
You will Want to Read the Discussion the Alabama Board of Pharmacy Had About the DQSA (sorry about format but it was in transcript form and difficult to reformat)
MS. ALVERSON: All right. As was
mentioned, the Senate passed the compounding bill this week on Monday. Donnie mentioned it
and once that gets implemented, and of course
when things get implemented, what you expect is going to happen doesn't always happen and the agency that writes it comes up with different
quirks in there but I think it's -- this bill is going to put us in a more difficult position in that the bill allows manufacturers -- what we all know to be manufacturers -- to make a choice: Do you want to put yourself under FDA compliance or don't you?
And you might think that most people would say, well, why would I want to be inspected by the FDA but some businesses to be
able to sell what they're manufacturing aregoing to need that FDA certification because
their customers are going to demand it but there will be others that don't and so for our office, it's going to mean much more in-depth inspections going through a lot more paperwork,looking at shipping records, looking at compounding records, all of which we most certainly intend to do but it is going -- it's going to be balancing whether the FDA picks up certain components or if -- or if we pick up those components for manufacturers in the State
and I guess we won't know until we actually see
how that law is implemented.
Important Fact:
In March 2013, eight states (New York, Pennsylvania, Maryland, New Jersey,
Delaware, Virginia, West Virginia, and Massachusetts) agreed to operate all of their racetracks
under strict new rules that will limit the number of approved medications for racehorses to 24
and will require the drugs to be accredited under standards set forth by the Racing Medication
and Testing Consortium. The agreement is set to take effect on January 1, 2014.Memorandum from Ranking Member Henry A. Waxman, “H.R. 2012 doping at horse racing
Memorandum from Ranking Member Henry A. Waxman, “H.R. 2012 ...
democrats.energycommerce.house.gov/.../Memo-CMT-HR-2012-Impro...
Some Aspects of Doping and Medication Control in Equine Sports
Purchase on Springer.com
$29.95 / €24.95 / £19.95*
* Final gross prices may vary according to local VAT.
Abstract
This chapter reviews drug and medication control in equestrian sports and addresses the rules of racing, the technological advances that have been made in drug detection and the importance of metabolism studies in the development of effective drug surveillance programmes. Typical approaches to screening and confirmatory analysis are discussed, as are the quality processes that underpin these procedures. The chapter also addresses four specific topics relevant to equestrian sports: substances controlled by threshold values, the approach adopted recently by European racing authorities to control some therapeutic substances, anabolic steroids in the horse and LC–MS analysis in drug testing in animal sports and metabolism studies. The purpose of discussing these specific topics is to emphasise the importance of research and development and collaboration to further global harmonisation and the development and support of international rules.
NSW Supreme Court Grants Injunction to Racing Veterinarians
December 27, 2013
The vets sought a delay in the start of a plan to license veterinarians treating racehorses in training. ... Read MoreThe Toadstool Millionaires: A Social History of Patent Medicines and the Federal Authority to Regulate the Compounding of Human Drugs by James Harvey Young
The Toadstool Millionaires: A Social History of Patent ...The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation. ... A Social History of Patent Medicines in America before Federal Regulation by James Harvey Young
5
Federal Authority to Regulate the Compounding of Human DrugsFederal Regulation of Compounded Drugs ... 12 See James Harvey Young, The Toadstool Millionaires: A Social History of Patent Medicines in America Before ... testified before a Senate subcommittee in 1938 in support of the legislation that while the
American Bar Association Health Law Section 15th Annual Conference on Emerging Issues in Healthcare Law Feb. 26th-March 1, 2014 in Litchfield Park, AZ
now available - American Bar Association
www.americanbar.org/content/dam/aba/.../emi_brochure_2014.pdf
Best, worst racing stories of 2013-drugs remain a problems in the Sport of Kings
Ritvo and Lukas inspired, but drugs remain a problem in the Sport of Kings
Updated: December 29, 2013, 10:52 AM ET
By Bill Finley | Special to ESPN.com
watch video and read here
Must Read: Experts: Florida Regulators Still Not Doing Enough by Fred Hiers
By FRED HIERS
HALIFAX MEDIA SERVICES
Published: Saturday, December 28, 2013 at 11:19 p.m.
Last Modified: Saturday, December 28, 2013 at 11:19 p.m.
Essential read! Editorial: Compound problems
Published: Sunday, December 29, 2013 at 6:01 a.m.
Last Modified: Thursday, December 26, 2013 at 10:41 p.m.
If chemical weapons killed 64 people on U.S. soil, the nation would be in a frenzy trying to determine what measures could be taken to prevent it from happening again.
Yet Americans largely reacted with a shrug when 64 people died, including four in Ocala, and thousands more were sickened last year due to tainted steroid injections.
Sure, the incident led to national media coverage of problems at the Massachusetts compounding pharmacy where the steroid was produced and others like it. But the state and federal response has been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight.
For the past nine months, Star-Banner staff writer Fred Hiers has investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. His eye-opening series recently published in The Sun, “Compound Fractures,” shows that the public remains at risk from unsafe drugs made at those pharmacies.
Last year's 64 deaths made for the most deadly compounding calamity in U.S. history. But they weren't the first deaths connected to compounding pharmacies. Drugs made in compounding pharmacies in Alabama, Maryland, South Carolina and Texas were previously linked to deaths due to problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.
continue to read here
Saturday, December 28, 2013
Must Read: FDA Warning Letter that Lead to a Civil Complaint Being Filed-compounding pharmacy did not have patient-specific prescriptions; unapproved new drugs; misbranded drugs and adulteration charges: Will we be seeing more and more of these types of warning letters in the future for those who fail to comply with the DQSA?
VIA UPS
SIGNATURE REQUIRED
WARNING LETTER
August 30, 2013
Scot M. Silber
President/CEO
FVS Holdings, Inc. dba. Green Valley Drugs
1850 Whitney Mesa Dr
Suite 180
Henderson, NV 89014-2091
Dear Mr. Silber:
Between March 11, 2013, and March 15, 2013, U.S. Food and Drug
Administration (FDA) investigators conducted an inspection of your facility,
Green Valley Drugs, located at 1850 Whitney Mesa Drive in Henderson, Nevada
89014. During the inspection, the investigators noted that you were not
receiving valid prescriptions for individually-identified patients for a
significant number of drug products you were producing. In addition, the
investigators observed serious deficiencies in your practices for producing
sterile drug products, which put patients at risk. For example, we observed
technicians touching the open neck of sterile vials and the bottom of sterile
stoppers with non-sterile gloves and performing hand-stoppering during aseptic
filling operations. In addition, staff was observed reaching over uncapped vials
containing sterile drug products during filling operations, thus disrupting the
unidirectional air protecting the vials and allowing for potential contact of
the vial top surfaces with non-sterile gown sleeves. Furthermore, FDA
investigators noted that sterilized vials are stored uncovered and unprotected
from microbial contamination on a shelf in the cleanroom. These practices place
your firm’s aseptically-produced injectable products at considerable risk of
microbial contamination. These observations and others were noted on an FDA Form
483 issued on March 15, 2013.
During teleconferences with your firm on April 5 and April 8, 2013, we
expressed our concerns about your firm’s poor personnel aseptic practices.
During our April 9, 2013 teleconference, you stated that you would cease
sterile drug production and make corrections based on the findings identified in
the FDA Form 483 issued on March 15, 2013. You also indicated that you would
request an FDA re-inspection after the corrections have been made. We expect
that you will notify this office before resuming production of sterile drug
products. We have not received a written response to the Form 483 issued March
15, 2013.
We acknowledge the April 11. 2013 voluntary recall of all sterile products
compounded, repackaged, and distributed by Green Valley Drugs.
Based on FDA’s March 11-March 15, 2013 inspection, it appears that you are
producing drugs that violate the Federal Food, Drug, and Cosmetic Act
(FDCA).
A. Compounded Drugs Under the FDCA
The FDCA establishes agency jurisdiction over “new drugs,” including
compounded drugs. See Medical Ctr. Pharm. v. Mukasey, 536
F.3d 383, 393-94 (5th Cir. 2008) (“compounded drugs are not exempt from the
FDCA's ‘new drug’ definition, § 321(p)”). The drugs that pharmacists compound
are not FDA-approved and lack an FDA finding of safety and efficacy. Because
compounded drugs are “new drugs” under the FDCA that are unapproved, the statute
generally prohibits their introduction into interstate commerce.
However, FDA has long recognized the important public health function
served by traditional pharmacy compounding. FDA regards traditional compounding
as the extemporaneous combining, mixing, or altering of ingredients by a
pharmacist in response to a physician’s prescription to create a medication
tailored to the specialized needs of an individual patient. See Thompson v.
Western States Medical Center, 535 U.S. 357, 360-61 (2002). Traditional
compounding typically is used to prepare medications that are not available
commercially, such as a drug for a patient who is allergic to an ingredient in a
mass-produced drug, or diluted dosages for children. As a matter of agency
discretion, FDA has historically not taken enforcement action against
traditional compounding in recognition of the benefit that it affords patients
when FDA‑approved, commercially available drugs are inadequate or
unavailable.
In 1997, Congress enacted, as part of the Food and Drug Administration
Modernization Act of 1997 (FDAMA), a provision that related to pharmacy
compounding, codified in section 503A of the FDCA (21 U.S.C. § 353a). In 2001,
the Ninth Circuit Court of Appeals declared this section invalid because it
included unconstitutional restrictions on commercial speech and those
restrictions could not be severed from the rest of section
503A. Western States Medical Center v. Shalala, 238
F.3d 1090 (9th Cir. 2001). The Supreme Court affirmed the Ninth Circuit ruling
that the advertising restrictions violated the First Amendment, but it
did not consider whether these restrictions could be severed from the rest of
section 503A. Thompson v. Western States Medical Center, 535
U.S. 357 (2002). In 2008, the Fifth Circuit Court of Appeals held that the
restrictions on commercial speech could be severed from the rest of 503A and
that the remainder of 503A is valid and in force. Medical Ctr.,
536 F.3d at 404. Thus, the decisions of the Fifth and Ninth Circuits
directly conflict on whether the non-advertising provisions of section 503A are
valid and in effect.
Your facility is located within the Ninth Circuit where section 503A is
invalid, and where FDA continues to apply the enforcement policy articulated in
Compliance Policy Guide section 460.200 [“Pharmacy Compounding”], issued by FDA
on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39, 409
(June 7, 2002)) (the “CPG”). The CPG identifies a non-exhaustive list of factors
that the Agency considers in deciding whether to initiate an enforcement action
with respect to compounding.
The CPG recognizes that traditional pharmacy
compounding practice involves receipt of valid prescriptions for individually
identified patients prior to distribution of a drug.[1] During
the FDA inspection, investigators observed that your firm does not receive valid
prescriptions for individually-identified patients for a significant number of
drug products you produce. Based on this factor alone, your conduct does not
qualify for the agency’s exercise of enforcement discretion set forth in the CPG
and remains subject to all of the FDCA’s requirements.[2] In addition, we
remind you that there are other factors that FDA considers in determining
whether to exercise enforcement discretion under the CPG.
B. Violations of the FDCA
The drug products that you manufacture and distribute are unapproved new
drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) [21
U.S.C. §§ 355(a) and 352(f)(1)] of the FDCA, respectively. In addition, your
sterile drug products are prepared, packed, or held under insanitary conditions
whereby they may have been contaminated with filth, or whereby they may have
been rendered injurious to health. As such, all sterile products you manufacture
are adulterated within the meaning of section 501(a)(2)(A) [21 U.S.C. §
351(a)(2)(A)] of the FDCA. Furthermore, the manufacture of those drugs is
subject to FDA’s Current Good Manufacturing Practice (CGMP) regulations for
Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210
and 211. FDA investigators observed significant CGMP violations at your
facility, causing such drug product(s) to be adulterated within the meaning of
section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].
Unapproved New Drug Products
You do not have any FDA-approved applications on
file for the drug products you manufacture and distribute, including
Methylprednisolone Acetate 40mg/mL and 80mg/mL.[3] Under
sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)] a new
drug may not be introduced into or delivered for introduction into interstate
commerce unless an application approved by FDA under section 505 of the FDCA [21
U.S.C. § 355] is in effect for the drug. Your marketing of these products, or
other applicable products, without an approved application violates these
provisions of the FDCA.
Misbranded Drug Products
Additionally, because the drug products you manufacture and distribute are
intended for conditions that are not amenable to self-diagnosis and treatment by
individuals who are not medical practitioners, adequate directions cannot be
written for them so that a layman can use these products safely for their
intended uses. Consequently, their labeling fails to bear adequate directions
for their intended uses, causing them to be misbranded under section 502(f)(1)
of the FDCA [21 U.S.C. § 352(f)(1)] and they are not exempt from the
requirements of section 502(f)(1) of the FDCA (see, e.g., 21 C.F.R.
§201.115). The introduction or delivery for introduction into interstate
commerce of these products therefore violates sections 301(a) of the FDCA [21
U.S.C. § 331(a)].
Adulteration Charges
Additionally, FDA investigators noted that your sterile drug products were
prepared, packed, or held under insanitary conditions, whereby they may have
become contaminated with filth or rendered injurious to health, causing your
drug products to be adulterated under section 501(a)(2)(A) of the FDCA [21
U.S.C. § 351(a)(2)(A)]. These conditions include technicians touching the open
neck of sterile vials and the bottom of sterile stoppers with non-sterile gloves
and performing hand-stoppering during aseptic filling operations. In addition,
staff was observed reaching over uncapped vials containing sterile drug products
during filling operations, thus disrupting the unidirectional air protecting the
vials and allowing for potential contact of the vial top surfaces with
non-sterile gown sleeves.
FDA investigators also noted CGMP violations at your facility, causing the
drugs you manufacture to be adulterated under section 501(a)(2)(B) of the FDCA
[21 U.S.C. § 351(a)(2)(B)]. The violations include, for example:
1. Your firm failed to establish and follow appropriate written
procedures that are designed to prevent microbiological contamination of drug
products purporting to be sterile, and that include validation of all aseptic
and sterilization processes (21 CFR 211.113(b)).
2. Your firm failed to adequately design the facility with adequate
separation or defined areas or such other control systems necessary to prevent
contamination or mix-ups (21 CFR 211.42(b)).
3. Your firm failed to establish and follow an adequate written testing
program designed to assess the stability characteristics of drug products and to
use results of such stability testing to determine appropriate storage
conditions and expiration dates (21 CFR 211.166(a)).
4. Your firm failed to establish an adequate system for cleaning and
disinfecting the room and equipment to product aseptic conditions (21 CFR
211.42(c)(10)(v)).
5. Your firm failed to ensure that manufacturing personnel wear clothing
appropriate to protect drug product from contamination (21 CFR 211.28(a))
6. Your firm failed to establish an adequate system for monitoring
environmental conditions in aseptic processing areas (21 CFR
211.42(c)(10)(iv)).
7. Your firm does not have, for each batch of drug product purporting to
be sterile and/or pyrogen-free, appropriate laboratory determination of
satisfactory conformance to final specifications for the drug product (21 CFR
211.167(a)).
C. Conclusion
The violations cited in this letter are not intended to be an all-inclusive
statement of violations that exist at your facility. You are responsible for
investigating and determining the causes of the violations identified above and
for preventing their recurrence or the occurrence of other violations. It is
your responsibility to assure that your firm complies with all requirements of
federal law and FDA regulations.
You should take prompt action to correct the violations cited in this
letter. Failure to promptly correct these violations may result in legal action
without further notice, including, without limitation, seizure and injunction.
Other federal agencies may take this Warning Letter into account when
considering the award of contracts.
FDA strongly recommends that your management immediately undertake a
comprehensive assessment of your manufacturing operations, including facility
design, procedures, personnel, processes, materials, and systems. In particular,
this review should assess the acceptability of your aseptic processing
operations. A third party consultant with relevant sterile drug manufacturing
expertise could be useful in conducting this comprehensive evaluation.
Within fifteen working days of receipt of this letter, please notify this
office in writing of the specific steps that you have taken to correct
violations. Please include an explanation of each step being taken to prevent
the recurrence of violations, as well as copies of related documentation. Your
written reply should be addressed to:
Lawton W. Lum, Director of Compliance
FDA San Francisco District Office
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
If you have questions regarding any issues in this letter, please contact
Russell A. Campbell, Compliance Officer at 510-337- 6861.
Sincerely,
/S/
Kathleen M. Lewis, J.D.
District Director
cc:
Larry L. Pinson, Executive Secretary
Nevada Board of Pharmacy
431 W. Plumb Ln.
Reno, NV 89509
431 W. Plumb Ln.
Reno, NV 89509
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