Thursday, June 27, 2013

Side Note: Federal nullification efforts mounting in states on various federal laws--but Law is not on the States' Sides

Imagine the scenario: A federal agent attempts to arrest someone for illegally selling a machine gun. Instead, the federal agent is arrested — charged in a state court with the crime of enforcing federal gun laws. Farfetched? Not as much as you might think.

The scenario would become conceivable if legislation passed by Missouri’s Republican-led Legislature is signed into law by Democratic Gov. Jay Nixon.

Don't Forget To Watch This Case Posted Earlier on the Blog--Dealing with Pain Medications--DOJ Files Suit Against Louisiana Pharm Company for Distributing Unapproved, Misbranded Drugs

DOJ Files Suit Against Louisiana Pharm Company for Distributing Unapproved, Misbranded Drugs

Acting Assistant Attorney General Stuart F. Delery announced that the Department of Justice (DOJ), on behalf of the FDA, has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, its president, Jivn-Ren Chen, MD, and its director of corporate quality, Charles L. Thomas, all of Shreveport, La. According to the complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products.

"Today's action furthers the FDA's mission of ensuring that all drugs sold to the public are safe and effective, and those companies that undermine this mission will be held accountable," said Mr. Delery.

This is the second injunctive case that the government has brought against Sage alleging the distribution of unapproved new drugs. In 2000, the government obtained an injunction against the company banning the manufacture and distribution of two unapproved new drugs. Since then, FDA inspections have allegedly revealed that the defendants continue to manufacture and distribute other drug product—including prescription pain relievers, over-the-counter (OTC) cough and cold remedies and OTC wound cleansers—without first obtaining the requisite FDA approvals.

"As a result, the defendants' products are unapproved new drugs and misbranded drugs under the FDCA, and potentially unsafe and ineffective," according to a press statement from the DOJ.

The release stated, "despite numerous warnings from [the] FDA, the defendants have failed to bring their operations into compliance with the law." The DOJ announced it will seek a permanent injunction requiring the defendants to cease all receiving, processing, manufacturing, preparing, packaging, labeling, holding and distributing activities until they comply with applicable FDA regulations.

The FDA referred this matter to the DOJ. The Consumer Protection Branch of the DOJ's Civil Division together with the U.S. Attorney's Office for the Western District of Louisiana brought this case on behalf of the United States.

—Based on a press release from the Department of Justice

quote from here

DEA: 8 arrested in Spice crackdown St. George may have been base for Spice ring

ST. GEORGE — Federal law enforcement officials unveiled a criminal complaint Wednesday alleging a synthetic drug trafficking ring with global reach was headquartered in St. George.

Fourteen Utahns have been arrested on charges of conspiracy to distribute a controlled substance (Spice), eight of them in Washington County, as part of what the Drug Enforcement Administration is labeling its largest synthetic drug take-down in history including 35 states, 49 cities and five countries.

“The complaint alleges that this organization manufactured here in Washington County and distributed throughout the United States thousands of pounds of Spice, and the proceeds garnered from that distribution totaled up to $12 million,” assistant U.S. Attorney Robert Lund said during a news conference at Purgatory Correctional Facility.

Lund said the potential street value of the Spice mentioned in the federal complaint was more than $17 million.

continue reading here

Press Announcements FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies

UN issue warning on synthetic drugs - International News - Keep up with Newstalk ZB

Question of the Day June 27, 2013 Will There Be A Round Two of the FDA Inspections? Has It already Started? Who Will Be Next On the List of High Risk Compounding Pharmacies? When Will

more states on their own inspect and take action against these high risk compounding pharmacies? Are should the FDA Inspect Some Good Compounding Pharmacies Next to Show the Public Not All Compounders Are Bad?

Repost of FDA 2013 Pharmacy Inspections Link

ORA FOIA Electronic Reading Room 2013 Pharmacy Inspections

FDA's Inspection Report of Americare Compounding in NY: Issued on June 19, 2013

read report here

Pharmacy Compounding Pharmacy Compounding: FDA Actions--warning letters back to 2008

Pharmacy Compounding Pharmacy Compounding: FDA Actions

Reminder Again: Obtaining an IND for Estriol

Obtaining an IND for Estriol

Some menopausal hormone therapy drugs compounded by pharmacies contain the ingredient estriol. Estriol is not a component of any FDA approved drug and it has not been shown to be safe and effective for the uses for which it is being prescribed.

Under a well-established policy, pursuant to an Investigational New Drug Application (IND), FDA permits drug compounding with active ingredients that - like estriol - are not components of FDA-approved drugs. The Agency's position has been improperly cast as a ban on estriol. But FDA has repeatedly stated that it respects a healthcare provider's decision that his or her patient should receive estriol.

At the same time, FDA must assure that patients receive accurate information about the risks and benefits of unapproved drug therapies so that they can make informed decisions about those therapies. The requirement for patients to give informed consent when receiving a product under an IND ensures that patients receive important safety information. Another advantage of INDs is their requirement that practitioners collect and report adverse event information to FDA.

There are some misconceptions that obtaining an IND is a costly, cumbersome, and time consuming process. To the contrary, INDs are well known, well understood, and widely used in the healthcare community. Thousands of physicians use INDs every day to treat patients with drugs that have not been approved by FDA. FDA does not charge a fee to file an IND, although review fees may be charged by private Institutional Review Boards. In addition, FDA has streamlined the IND process for estriol to make it as efficient and convenient as possible for practitioners, while still maintaining patient safety.

Under this streamlined process, FDA is willing to accept INDs covering multiple patients, on behalf of multiple health care providers, and for a range of doses. The general requirements for practitioners filing an IND application for estriol are:

Completed FDA Form 1571

Drug formulation and chemistry information including:

Names and addresses of the pharmacies making the drugs
Attestation from the pharmacies that they will use only USP/NF grade ingredients and adhere to USP processes and procedures when preparing the compounded products
Detailed description of the drug formulation that will be used (ingredients, quantities, and production processes)

Clinical information including:

Number of patients
Types of symptoms that will be treated by the drugs
Dose ranges for each formulation
Monitoring procedures, including safety monitoring
Copy of current medical license of the practitioner

For more information regarding IND or new drug application submissions for drugs containing estriol, please contact Margaret Kober in the Division of Reproductive and Urologic Products at 301-796-0934.

Please submit all completed IND applications for estriol to the following address:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705
Attn: Margaret Kober

Consumer Updates Bio-Identicals: Sorting Myths from Facts--FDA's view on BHRT

Consumer Updates Bio-Identicals: Sorting Myths from Facts

Press Announcements FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers

Fungal meningitis outbreak update: Infection traveled surprising route

read article here

Experts skeptical of compounding pharmacy practices

Endocrine Today, June 2013

Pharmaceutical compounding, defined as the combining or mixing of pharmaceutical ingredients to create a customized medication for a patient, has recently come under fire due to sterility issues. Now, controversial regulatory issues and recent legislative action have caused experts to speak out about the clinical implications of compounded thyroid agents and the controversies surrounding this typically unchartered territory for clinicians.

“The bottom line with compoundingpharmacies is that they are state regulated and the regulation is not very rigid. In theory, it’s a custom prescription for each patient,”James V. Hennessey, MD, associate professor of medicine at Harvard Medical School and clinical director of the division of endocrinology, diabetes and metabolism at Beth Israel Deaconess Medical Center, toldEndocrine Today. “I’m primarily convinced that levothyroxine is the mainstay of therapy, and I’m underwhelmed with the literature that tells me [triiodothyronine] compounds are of predictable benefit to patients. I’m willing to read about it and I’m willing to look at the evidence; however, at this time, I’m not anticipating that I will be using compounding pharmacies.”

http://www.healio.com/endocrinology/practice-management/news/print/endocrine-today/%7B0DDA820F-D873-4259-989F-245C54BFAC57%7D/Experts-skeptical-of-compounding-pharmacy-practices

White Paper | June 26, 2013 Challenges With Modern Oncology Drugs: Aeseptic Preparation Of Cytotoxic Compounds

Source: Bioquell Inc.

Jane Metcalfe BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd

Chemotherapy treatments are advancing rapidly with increasing numbers of clinical trials in the field of oncology. With the emergence of personalised medicine and targeted therapeutics, there has been a rise in the number of biological therapies used to treat cancer. The amalgamation of targeted therapies and traditional cytotoxic drugs, has led to the formulation of antibody-drug conjugates which ensure direct cytotoxic delivery to tumour cells.

It is anticipated that hospital pharmacies will be compounding a diverse range of cytotoxic products including new drug conjugates in future. In order to accommodate these changes, it is paramount that rigorous systems of quality risk management (QRM) are employed. Good manufacturing practice (GMP) must be adhered to, in order to assure that products are produced accurately, safely and aseptically. Workloads in technical services departments are expected to increase, so capacity needs to be examined alongside service provision.

With the predicted increases in throughput, validated methods of isolator bio-decontamination are imperative to reduce the resident contamination in the critical zone. A marked reduction in bioburden combined with good aseptic technique, can facilitate product protection and ultimately, patient protection. Isolator technology can be utilised to ensure the segregation of products to prevent cross-contamination. Historically this has concerned the ß-lactam group of antibiotics but, with advances in pharmacology and drug design, this will encompass additional
product types. Both legislative and regulatory guidelines will require individual consideration and procedural application.

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Obama Administration Threatens To Veto House FDA Funding Bill

The Obama administration said Tuesday (June 25) that the president will veto a House FDA funding bill that givesthe agency a funding increase in fiscal 2014, but falls short of the administration's request and does not include proposed new . . .

continue to read here

CDC issues final analysis of fungal contamination in steroid injections TOP NEWSJUNE 26, 2013BY: PAUL HAMAKER

Investigators from the Centers for Disease Control and Prevention (CDC) describe pathologic findings from 40 case reports of fungal infection in patients who had been given contaminated epidural, paraspinal, or intra-articular (into joints) steroid injections and correlated these findings with clinical and laboratory data published on June 26, 2013, that will appear in the August 2013 issue of The American Journal of Pathology

continue reading here

Question of the Day June 26, 2013 Will US Attorney's Offices and DOJ continue to investigate Compounding Pharmacies Who Do High Amounts of Compounding of Pain Medications?

Will they continue to find ties between the abuses of pain medications and compounding pharmacies?

Important!! Breaking News: Papers sought from pain clinics Subpoenas tied to meningitis outbreak Jun. 26, 2013

MARION — Two pain management clinics in Marion have received subpoenas seeking documents that could provide information on allegations their patients received injections of tainted medication that led to serious illness, an attorney with a steering committee appointed by a U.S. district court judge said.

The subpoena originated in the U.S. District Court for the District of Massachusetts, which is overseeing the consolidation of most cases in federal and state court alleging personal injury or wrongful death as a result of the contaminated injections.

In October, the Centers for Disease Control and Prevention began coordinating a multistate investigation of fungal meningitis among patients who had received epidural injections from three lots of steroids manufactured by New England Compounding Pharmacy Inc. in Framingham, Mass.; fungal meningitis is not contagious.

Textbook for Vets Addresses Issues Relating to Compounded Drugs

Textbook of Veterinary Internal Medicine

By Stephen J. Ettinger, DVM, DACVIM and Edward C. Feldman, DVM, DACVIM

Chapter 160 – Compounding Drugs

Ron Johnson

One of the greatest challenges to veterinarians can be the availability of appropriate drug dosage forms that enable easier dosing of small dogs and cats and improve owner compliance. Although advances have been made with new drugs and dosage forms approved for veterinary medicine, clearly there is an unmet need with drug formulation options and dosages. As such, drugs approved in one animal species are frequently used in another species, including human-approved drugs. Compounded drugs can alleviate some of the drug-related issues facing veterinary medicine provided compounding is approached in a rational manner. There is little doubt that compounded drug formulations can offer effective and safe delivery options to veterinary patients. Support for this comes from the large number of pharmacies offering compounded drug products for veterinary patients and the increasing number of peer-reviewed journal articles that involve compounded veterinary …

UNDERSTANDING RISKS VERSUS BENEFITS WITH COMPOUNDED DRUGS

Pharmaceutical Issues

Compounding by medical professionals and pharmacists is not equivalent to the formulation of commercially manufactured products by reputable pharmaceutical firms. Drug formulation requires an understanding of the physical and chemical characteristics of the active pharmaceutical ingredient, along with the other agents (e.g., vehicles, excipients) used to produce the administered dosage form, in order to maintain the administered drug's effectiveness and safety profile. To this end, a compounded drug must possess adequate purity, potency, and demonstrate stability (shelf life) to maintain acceptable bioavailability (extent of systemic drug absorption) of the active pharmaceutical ingredient, but not produce toxicity or an ineffective preparation. However, for the vast majority of drugs compounded by veterinarians and most pharmacists, there is a lack of adequate pharmaceutical and clinical testing to ensure …

Transdermal Delivery of Drugs in Organogels

Transdermal administration of drugs for animals has the potential to be effective, safe, and can certainly enhance compliance. Absorption of drug via the transdermal route is primarily passive. As such, ideal molecules for this route of delivery are low molecular weight (<400 Daltons), lipophilic, and soluble in both water and oil.^[10,11] Attention in veterinary medicine has focused on transdermal delivery of various drugs in organogels formulated for pulsed (single dose) therapy versus continuous release reservoirs (e.g., fentanyl patch (Duragesic).^[12]

The growing list of drugs available in transdermal organogel formulations from compounding pharmacists includes antimicrobials, anticonvulsants, hormones, antineoplastics, prokinetic drugs, analgesics, and antiinflammatory agents. The vast majority of these compounded products are prepared in a pluronic lecithin organogel (PLO) vehicle. Lecithin is an emulsifying agent that forms a viscous gel when …

COMPOUNDING BY THE VETERINARIAN AND PHARMACIST: ROLES AND RESPONSIBILITIES

Compounding should be conducted in accordance with good pharmacy and compounding practices, relevant scientific literature, and applicable state laws. Pharmacy facilities used for compounding should have adequate room and equipment, be maintained in a clean and sanitary condition according to standard operating procedures in order to be effective, and prevent contaminations and errors. The USP 31-NF 26 contains a general chapter <1075> that addresses components of good compounding practices. These include responsibilities of the compounder, compounding facilities and equipment, recommendations for minimal training, and requirements for product packaging, labeling, and record keeping.^[8]Importantly, there is now recognition of a separate veterinary compounding category by the USP-NF. The FDA Center for Drug Evaluation and Research has put forth a concept paper that evaluates drug products for human use that …

REFERENCES

1.. U.S. Code of Federal Regulations, Title 21—Food and Drugs: Part 530, Extralabel Drug Use in Animals, 1994.

2.. Center for Veterinary Medicine, US Food and Drug Administration Web site: Compounding of Drugs for Use in Animals. Compliance Policy Guide. Ch 6 608.400. Available atAccessed August 2008 www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html

3.. Geyer RE: Extralabel drug use and compounding in veterinary medicine. Food Drug Law J 1997; 52(3):291-295.

4.. Davidson G: The compounding controversy: what veterinarians should know to protect themselves and their patients. J Am Anim Hosp Assoc 2003; 39:13-17.

5.. Jordan DG: Pharmacist compounding vs veterinarian compounding: similarities and differences. J Am Vet Med Assoc 1994; 205(2):256-260.

6.. Riddell MG: AVMA's position on compounding for animals. Int J Pharm Comp 2005; 9(3):247-248.

7.. Papich MG: Drug compounding for veterinary patients. Am Assoc Pharm Sci 2005; 7(2):E281-E287.

8.. United States Pharmacopeia: Good compounding practices, The United States Pharmacopeia 31-National Formulary 26, Rockville, Md, 1075:500-503, 2008.

9.. United States Pharmacopeia: Pharmaceutical compounding-nonsterile preparations, The United States Pharmacopeia 31-National Formulary 26, Rockville, Md. 795:315-319, 2008.

10.. Marks SL: Transdermal therapeutics. J Am Anim Hosp Assoc 2003; 39:19-21.

11.. Riviere JE, Papich MG: Potential and problems of developing transdermal patches for veterinary applications. Adv Drug Deliv Rev 2001; 50:175-203.

12.. Davidson G: Update on transdermals for animal patients. Int J Pharm Comp 2005; 9(3):178-182.

13.. Bennett N, Papich MG, Hoenig M, et al: Evaluation of transdermal application of glipizide in a pluronic lecithin gel to healthy cats. Am J Vet Res 2005; 66:581-588.

14.. Hoffman SB, Yoder AR, Trepanier LA: Bioavailability of transdermal methimazole in a pluronic lecithin organogel (PLO) in healthy cats. J Vet Pharmacol Ther 2002; 25:189-193.

15.. Sartor LL, Trepanier LA, Kroll MM, et al: Efficacy and safety of transdermal methimazole in the treatment or cats with hyperthyroidism. J Vet Intern Med 2004; 18(5):651-655.

16.. Center for Drug Evaluation and Research, U.S. Food and Drug Administration: Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness. Rockville, Md, FDA Concept Paper, 2000.

17.. Davis J: Compounding for creatures: what works. Int J Pharm Comp 1999; 3(3):182-185.

source and to preview textbook click here

Dr. Richard Moon Stated Several Years Ago That The Compounding Industry Was Working on A Serious System to Track Adverse Compounding Events

Read his post here

Wednesday, June 26, 2013

7 Md. outpatient centers get subpoenas in meningitis outbreak investigation

By Scott Dance, The Baltimore Sun

Updated June 25, 2013

Seven Maryland health care centers that received tainted steroids linked to a nationwide meningitis outbreak will be required to turn over documents and give testimony under subpoenas filed last week in a federal lawsuit.

A steering committee of lawyers representing patients who were given doses of the medication filed 76 of the subpoenas across the country. Patients in 22 states received injections of the steroids last year before they were recalled; 745 of them developed fungal meningitis or other health issues as a result, and 58 died.

"The purpose is to shed light on how this all happened," said Elisha Hawk, a lawyer with the Pikesville firm Janet, Jenner & Suggs, who is leading the steering committee's efforts in Maryland. There were 26 cases of meningitis and other illnesses in Maryland, and three deaths.

The subpoenas were filed Friday in U.S. District Court for Massachusetts, where federal lawsuits from around the country are being consolidated. New England Compounding Pharmacy Inc., of Framingham, Mass., is the defendant in the lawsuits, accused of substandard practices that led to contamination of three lots of the steroids.

Continue reading here

TN clinics served with subpoena in meningitis outbreak

Citizens for Health Opposes Senate 959-Compounders and Consumers Worry FDA Will Eliminate BHRT -one change to draft that could be made now to draft to ensure this does not happen is for Congress to add list of drugs or compounds FDA cannot remove without Congressional action/ approval And also include private citizens as blog suggested before on committee who creates Do Not Compound List

Preserve Access to BHRT and Stop FDA Expansion of Power

A bill will be voted on soon that would restrict or eliminate your access to bioidentical hormone replacement therapy (BHRT) and give the FDA broad and unprecedented power to regulate compounding pharmacy.

S. 959, The "Pharmaceutical Compounding Quality and Accountability Act", would empower the FDA to ban certain compounding components if, in their opinion, they represent public health concerns.

S. 959 takes a stronger anti-patient stance than any proposed legislation seen in years and is another example of the ever-widening control the FDA is trying to impose on our bodies.

In 2008 the FDA attempted to restrict the female hormone estriol in response to a Citizen Petition from a drug company that marketed competing synthetic hormones. The FDA imposed import bans and sent warning letters to pharmacies and suppliers in an effort to prevent women from acquiring BHRT with estriol, but had no power of enforcement. S. 959 gives the FDA that power.

The bill goes even further - S. 959 would vastly expand FDA authority over all biological products except human blood and blood components for transfusion, effectively allowing the FDA to shut down nearly all adult stem cell treatments. This would not only set back critical research, but it would compromise access to existing treatments - all in the name of protecting the interests of big pha

Compounding Pharmacy and Specialist Jobs in Singapore

More information here

Compounding Pharmacy Sales Representative Opening

Compounding Pharmacy Inside Sales Representative Company: N/A Location: Boca Raton, FL Pay: N/A	Contact Information Name: Tanner Suer Phone: 888-242-7996 Fax: n/a
Apply Online

Job Description

KRS Global Biotechnology, Inc is a rapidly growing compounding pharmacy looking for highly motivated inside sales professionals to market services and build new business in several different vertical markets. We offer an excellent income of a base salary plus commission in a very difficult job market. Looking to fill open position to build sales force and new business immediately.

This position is ideal for those who look to have control of their finances .

If you have a great attitude and are self motivated to succeed, look no further and stop selling yourself short..Your future begins here!

Job Requirements

Job qualifications:

Minimum Experience : 1-3 years of inside sales experience

Skills needed:

Self-motivated ,high energy, and a desire to succeed

Communication skills- written and oral

Strong Salesmanship

Computer literacy

Analytical skills

Quick learner

Goal- oriented

FDA wants to stop large compounder from reopening Agency seeks injunction against Med Prep Consulting Read more: FDA wants to stop large compounder from reopening

Agency seeks injunction against Med Prep Consulting

June 26, 2013 | By Eric Palmer

Dr. Woodcock Confirmed to Speak: Understanding cGMPs - What Attorneys Need to Know

WASHINGTON, June 26, 2013 /PRNewswire-USNewswire/ -- Professionals working in the pharmaceutical and biologics industries, especially lawyers, need to understand the current framework for creating and following current Good Manufacturing Practices (cGMPs), and the steep legal and regulatory consequences for failing to meet those standards. This one-day, Food and Drug Law Institute (FDLI), program is specifically tailored for lawyers, but appropriate for all drug and biologics stakeholders. The July 10 conference in Washington, DC will provide an overview of cGMPs (including revisions mandated by enactment of Section 711 of FDASIA), how FDA evaluates company compliance with cGMPs (including an examination of recent guidelines published by the International Conference on Harmonization and the latest developments on quality by design), and practical advice for how to remain current and compliant. Don't miss this opportunity to learn directly from FDA and industry experts about the most current methods for compliance and quality management.

(Logo: http://photos.prnewswire.com/prnh/20121211/DC27524LOGO)

Confirmed government participants: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Laura A. Rich, Chief, Regulations and Policy Staff, Office of the Center Director, Center for Biologics Evaluation and Research, Office of Medical Products & Tobacco, FDA; Douglas Stearn, Deputy Director, Policy and Analysis, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice.

http://www.fdli.org/conferences/conference-pages/understanding-cgmps/general-information

Contact:

Erin Jones

VP, Marketing

The Food and Drug Law Institute

202-222-0899

U.S. Dept. of Justice sues to keep Tinton Falls-based drug compounding business closed

By Alexi Friedman/The Star-Ledger

Email the author | Follow on Twitter

on June 26, 2013 at 5:08 PM, updated June 26, 2013 at 5:40 PM.

The U.S. Department of Justice has filed a lawsuit to keep a Tinton Falls-based drug compounding business closed three months after mold was discovered in five intravenous bags it had prepared for a hospital.

The complaint against Med Prep Consulting and its owner, Gerald Tighe, cited numerous health violations, drug misbranding and years of repeated failures to comply with warnings as evidence of wrongdoing. The lawsuit, on behalf of the Food and Drug Administration, was filed Friday in federal court in Trenton.

The government is seeking an injunction to keep Med Prep closed permanently unless the company can prove it has complied with health and safety guidelines under the Federal Food, Drug, and Cosmetic Act. According to the lawsuit, FDA violations against Med Prep date to 2009. “Despite these warnings, defendants’ violations have persisted,” the lawsuit said.

Med Prep has remained shut since issuing a nationwide recall of all its drugs following discovery of contaminated bags of magnesium sulfate that were compounded and dispensed to a Connecticut hospital. The recall included dozens of drugs packaged in infusion bags, plastic syringes and glass vials distributed to 70 hospital and health care facilities throughout New Jersey, Pennsylvania, Connecticut and Delaware.

By HEALTH NEWS FLORIDA

Christopher George told a jury that he made close to $40 million running pill mills in South Florida with his twin brother, the South Florida Sun-Sentinel reports. He said they took in so much cash they had to store it in garbage cans, the Palm Beach Post reports. Testimony from George, who is serving 17 1/2 years in federal prison, could help convict two doctors who worked at the so-called pain management clinics who are charged in the overdose deaths of nine patients.

Continue to read here

More Information on Tricare Insurance Not Covering Compounded Medications

NEW - Important Information About Your Compounded Medications

The TRICARE pharmacy benefit covers medications approved by the Food and Drug Administration (FDA). Some compound prescriptions use ingredients that aren't FDA-approved as safe and effective. Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients of a drug in response to a prescription to create a medication tailored to your medical needs. For the safety of beneficiaries, when a compound prescription has an ingredient that isn't FDA-approved, TRICARE won’t cover the prescription.

Express Scripts is sending letters to beneficiaries who are using compound prescriptions that TRICARE will no longer cover as of July 24, 2013. TRICARE policy on compound prescriptions hasn’t changed. Clickhere (PDF file) to view an example letter. You can also view an example letter by visiting the Source Documents tab of the Customer Service Community website atwww.tricare.mil/customerservicecommunity/source.aspx under the Pharmacy Notifications button.

What you need to do

Please consult 32 CFR 199.4(d)(3)(vi)(B) for more information. Additional requirements for medication coverage are detailed on the following web site:http://www.tricare.mil/Pharmacy/Medications.aspx
If you are still using this medication please talk with your doctor to see if there is an appropriate alternative that is covered.

Announcement from Oklahoma Board of Pharmacy Regarding New Hydrocodone Law

June 26, 2013

New Hydrocodone Law: Effective November 1, 2013, prescriptions for any medication containing Hydrocodone may not be refilled. This applies even if the prescription was written prior to November 1st. Transfers are considered to be a refill of a pre-existing prescription and are not allowed. Partial fills would be permitted (i.e. a prescription is written for 100 but the patient only wants to purchase 20 at a time). Documentation for partial fills would be required in accordance with OAC 475:30-1-12. Hydrocodone combination medications are still classified as a CIII product and may be phoned in. Mid-level practitioners (nurse practitioners, physician assistants, etc.) may continue to prescribe Hydrocodone combination medications at this time.

April 29, 2013

Oklahoma Board of Pharmacy Agenda for April 27, 2013 Meeting

8:00 a.m.

FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Call meeting to order and record Board members present and absent in compliance with Open Meeting Act and Authority.
Approve minutes.
Approve expense claims.
Approve accrued expenses of the Executive Director. Approve May 2013 leave report of Executive Director.
FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:

1) Canceled Pharmacist list.
2) Canceled Pharmacy list.
3) Canceled Facility list.
4) Canceled Technician list.
5) Set Board dates.
6) Executive Director’s report.

FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Evidentiary Hearing on Complaints
OSBP vs. Jennifer Dawn Ford, Technician #15989 – Case No. 1184
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.

Proposed Executive Session pursuant to 25 O.S. Supp 2008, § 307 (B) (8); possible Board action. OSBP vs. Carolina M. Marroquin, Technician #16353 – Case No. 1187
Proposed Executive Session pursuant to 25 O.S. Supp 2008, § 307 (B) (8); possible Board action. OSBP vs. Yolanda Rodriguez, Technician #16769 – Case No. 1188
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action. OSBP vs. Alexis Vinavong, Technician #16681 – Case No. 1189
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Board visits with Reciprocity, Score Transfer and NAPLEX applicants.

Reciprocity: Score Transfer:
Stephanie Gench .........TX Jamison Niewoehner ...SD Jeremy Gurtz ...............IN
Francis Harbison..........AL
Ashley Harlow ..............IN
Amanda Marascalco ....TN Richard Nance .............OH Bhumi Patel..................IL Dominick Salvatore ......MO Murray Wall..................TX

NAPLEX:
Michael Frye Tressa McMorris

Page 1 of 2FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:

Evidentiary Hearing on Complaints
OSBP vs. William Travis Tate, D.Ph. #14726 – Case No. 1190
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action. OSBP vs. Bivens Drug, Inc., #70-5920 – Case No. 1193
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action. OSBP vs. Jerry Lee Dennis, D.Ph. #9252 – Case No. 1194
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action. OSBP vs. Flourish Integrative Pharmacy, LLC, #1-5179 – Case No. 1195
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action. OSBP vs. Christopher Darwin Rice, D.Ph. #14993 – Case No. 1196
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Evidentiary Hearing on Complaints
OSBP vs. Heath Branscum, D.Ph. #12336 – Case No. 861 – Request for Preceptor license
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
OSBP vs. Jeffrey A. Zander, D.Ph #9659 – Case No. 535 – Request for
Preceptor license
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
OSBP vs. Mark McCullough, D.Ph. #10336 – Case No. 1102 – Request for
Probation
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
OSBP vs. G. Geoffrey Craig, D.Ph. #8755 – Case No. 646A – Request for
Probation
Proposed Executive Session pursuant to 25 O.S. Supp 2009, § 307 (B) (8); possible Board action.
ADJOURNMENT

JUNE 27, 2013
“Special Meeting”
OKLAHOMA STATE BOARD OF PHARMACY
4545 N Lincoln Boulevard, Suite 112, Oklahoma City, Oklahoma 73105-3413