New details in DA's admonishment in Signature Pharmacy case

Soares' characterization in pharmacy case earned criticism, papers show

By James M. Odato

Published 10:02 p.m., Wednesday, August 29, 2012

ALBANY — With two weeks to go before Primary Day, a sworn deposition from Albany County District Attorney David Soares offers new details about his secret admonishments by a judicial panel that criticized him for publicly characterizing defendants in a steroid case as drug dealers and for discussing the investigation of a local police chief.

In a 145-page transcript of sworn testimony from Soares, the two-term Democrat seeking re-election this year sparred with an attorney for owners of Signature Compounding Pharmacy, who though facing indictment are suing Soares for defamation.

Soares was twice admonished by a state judicial panel for inappropriate comments by the district attorney that were later published in the newspaper, according to a legal records filed in federal court in Florida on Tuesday. The deposition and other documents were shared with reporters covering Soares' primary campaign against Lee Kindlon. The two will square off in a Sept. 13 primary.

The promptly produced transcript from last week's testimony shows Soares was admonished for characterizing those involved with Signature Pharmacy as akin to Tony Montana, the fictional cocaine kingpin in the movie "Scarface." Soares made the comments in an interview about the illegal pharmaceutical industry and Signature's lawyers contend the comments harmed their reputations. The plaintiffs accused Soares of defamation and the deposition was taken as part of that legal case. The case is slated to go to trial in February. Five operators of the pharmacy face felony charges after allegedly being implicated in a steroids distribution network.

During questioning, Soares also revealed a separate admonishment was for comments he made about Guilderland Chief James R. Murley to a Times Union editorial board. In October 2008, Soares was quoted as saying Murley, who was accused of defrauding the government by going to a casino while on public time, was in discussions about a plea bargain. In October 2009, Murley pleaded guilty to misdemeanor, admitting that on more than 50 occasions he claimed to have been working when he was actually gambling at an Oneida County casino.

The admonishment letters have never been revealed to the public. Soares told the attorney who questioned him that he shredded the admonishments and could not provide them.

Soares' testimony took place on Aug. 24.

Read more: http://www.timesunion.com/local/article/New-details-in-DA-s-admonishment-3825865.php#ixzz25A31tH2P

Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads

[Posted 08/29/2012]

AUDIENCE: Risk Manager, Pharmacy

ISSUE: FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition Compounder Systems, due to incorrect key press responses, caused by fluid entry into device keypads, and intermittent electrical failures. Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.

The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death.

BACKGROUND: Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.

RECOMMENDATION: Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call             1-800-332-1088       to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/29/2012 - Recall Notice - FDA]

FDA Now Has A Presentation Library On-Line

The Center for Drug Evaluation and Research now has a presentation library on-line that can be viewed here.

One Company Working to Bring Back Animal Parasiticides and Therapeutic Brands

Novartis pleads with veterinarians: ‘Save us a spot’

August 29, 2012
By: Jennifer Fiala
For The VIN News Service 

Novartis wants veterinarians to know that the company is “working diligently” to return its parasiticides and therapeutic brands to market after nearly 10 months of manufacturing setbacks and is imploring practitioners to resume using the company’s products once they come back.   

In a letter dated Tuesday to veterinarians, Novartis Animal Health sales executive Andy Ferrigno did not provide firm distribution dates for Interceptor Flavor Tabs and Sentinel Flavor Tabs. Both of the popular anti-parasitics have been backordered since Novartis’s manufacturing plant in Lincoln, Neb., closed last December. The shutdown followed a series of U.S. Food and Drug Administration (FDA) reports that revealed manufacturing mishaps and sloppy quality control procedures. 

Other veterinary-specific drugs including the anti-anxiety medication Clomicalm (clomipramine hydrochloride); Program tablets and suspension; Milbemite; and the arthritis pain medication Deramaxx (deracoxib) also are casualties of manufacturing woes at the Lincoln facility.   

The absence of Interceptor and Sentinel, however, is attracting the most attention from veterinarians; the drugs are used monthly for parasite control. With production of Novartis pet parasiticides on hiatus, drug companies carrying competing products might offer discounts and delayed payment options to veterinarians. In a densely populated and competitive market, one objective might be to provide veterinarians with enough stock to ensure they won’t return to Novartis brands once distribution recommences.  

“Your clinic will be approached in the coming months by our competitors, offering you load-in deals and terms that may draw your interest,” wrote Ferrigno, vice president of sales. “While we understand your need to do what is right for your business, patients and clients, we hope you will seriously consider saving us a spot on your shelves. We politely ask that you give your Novartis sales representatives a chance to earn back your business …”   

Despite the plea, Dr. John Daugherty thinks Novartis’s market share in animal health might be damaged permanently. Like his colleagues, he has 20 or more flea and tick products and roughly 10 heartworm preventatives from which to choose. Once an exclusive user of Interceptor and Sentinel, the practice owner in Poland, Ohio, said he’s not returning to Novartis-brand parasiticides anytime soon.   

“I had 1,500 patients on Interceptor,” Daugherty said. “We can’t go a whole year without heartworm preventative. At this point, we have almost all of our clients switched over to something else. I’m not going to tell them next year that they now need to switch back.”    

Other veterinarians are angered that Novartis continues to offer vague re-release dates. At least one practitioner took to the message boards of the Veterinary Information Network (VIN), an online community for the profession and parent of the VIN News Service, to vent his frustration about the lack of concrete information in Ferrigno’s letter.  

“This really isn’t an update (but) more than a PR (public relations) letter,” wrote Dr. Rich Selkowitz, a practitioner in Rockaway, N.Y. “I am sick of giving clients a date on the return of your products based upon information given by drug reps, and then having to inform them that, nope, we don’t have it yet.”   

Another source of contention: The online pharmacy Drs. Foster & Smith and some other retail outlets are stocked with Interceptor and Sentinel despite the halt in production and Novartis’s policy to only sell its products to licensed veterinarians.   

“To find out that I have clients getting it from Foster and Smith after telling them that there was no way that Foster and Smith had any only makes me look like a lying you-know-what to my clients,” Selkowitz wrote in the discussion. “If you want me to ‘save a spot’ on my shelf, give me real dates as to when I can expect product shipment.”   

A representative of Wisconsin-based Drs. Foster & Smith confirmed that the company is carrying Interceptor and Sentinel in select weight classes for dogs. Both of the drugs require a veterinary prescription.   

Spokesman Gordon Magee declined to confirm whether Novartis sells directly to Drs. Foster & Smith or if the online pharmacy is supplied with backordered Novartis products via gray market channels — a means of distribution that allows retail and online pharmacies to circumvent manufacturers’ policies to sell their products exclusively through veterinary practices. The system is legal, at least for non-prescription medications, but considered unethical by much of the veterinary profession.   

“We do keep detailed records for where we source our products, but we don’t reveal sources,” Magee said by email. In a phone interview, he explained that Drs. Foster & Smith keeps its sources confidential to stay abreast of competition from other online pharmaceutical outfits catering to animals.  

Contacted by the VIN News Service, PetMed Express cited a “nationwide shortage” when asked if the online pharmacy had Interceptor or Sentinel in stock. A Costco pharmacy in Middleton, Wis., carried a supply of Sentinel, but not in every weight class.   

In his letter, Novartis’s Ferrigno insinuated that the company is investigating how its products are cropping up online despite the fact that veterinarians can’t get their hands on them.   

“Over the past several weeks, we have received numerous comments from our veterinary customers that some of our out-of-stock brands have been found in certain retail chains and stores,” he wrote. “This has prompted some concern and frustration that we may be selling our limited supply of product into that segment rather than to the veterinary channel. I can personally assure you that this is not the case.”   

He reaffirmed Novartis’s policy to distribute products only to veterinarians and alluded to the possibility that practitioners who purchased Novartis products may have resold them to brokersthat supply online and retail sectors.   

“Any product that found its way into those retail channels was most likely diverted without our knowledge … either from residual customer inventory that predated our product shortages or, quite disappointingly, product shipped from our limited inventory this year,” Ferrigno wrote. “We will continue to investigate the situation and put measures in place that will help ensure the integrity and proper administration of our products.”   

Dr. Maren Bell Jones of Columbia, Mo., doubts the company’s sincerity.   

“I would like to be 100 percent moved on from Novartis products,” she said. “Don’t promise that you’ll be back up and running, fail to do that and then get product out to these other (retail and online) places. I’d like them to be straightforward instead of being so vague. The whole thing irritates me.”  

Novartis spokesman Joe Burkett said by email that he couldn’t “speak to” the frustration expressed by some veterinarians. When asked to pinpoint a re-release date for products manufactured in Lincoln, he pointed to a fact sheet posted on the company’s website, reporting that some Novartis Animal Health are in “various stages of pre-production and production.” 

“Production, packaging and shipping of the 5-mg strength of Clomicalm (clomipramine hydrochloride) is now ongoing at the Lincoln plant, and shipments of that stock keeping unit (SKU) began in mid-June,” the website says. “We also have initiated validation batch production of Sentinel (milbemycin oxime/lufenuron) Flavor Tabs at the plant, a critical phase of process testing that is required before full scale production can begin. As we validate, technical issues do arise.   

“Due to the evolving situation at the plant, we cannot give exact dates when product will be shipping."   

Article is found here.

 

 

Animal Endocrine Clinic: Methimazole-Handling Precautions for Cat Owners

Animal Endocrine Clinic: Methimazole-Handling Precautions for Cat Owners

Hospital pharmacists must get creative amid drug shortages

By TIMOTHY MAGAW 4:30 am, September 3, 2012 The medicine cabinets at Northeast Ohio's hospitals are sparse these days, and while it's no fault of their own, a nationwide drug shortage has forced pharmacists to come up with creative ways to make supplies of medications last. Although the federal government has offered a few tools to ease the burden, local hospital pharmacists say the shortages show few signs of easing. More than 200 drugs are in short supply or unavailable entirely; the bulk of these are generic injectable drugs. Alternatives, if they exist, often are sold at high markups. One hard-to-come-by pain medication typically costs the Cleveland Clinic 10 cents a dose. But, given the difficulty in securing the drug, the health system instead purchases an alternative that costs upwards of $10 a dose, according to Scott Knoer, the system's chief pharmacy officer. “Every hospital is working on this, and most of the public never even knows how much work goes into handling the problem,” said Mr. Knoer, who has a full-time staff mem-ber devoted to managing the issue. The reasons for the drug shortages are wide-ranging. Several drug manufacturers have closed or consolidated operations in the face of shrinking profit margins, a trend health care observers say has suffocated the supply chain. In addition, the U.S. Food and Drug Administration contends more than half of the shortages are a result of quality issues that forced regulators to shutter, either permanently or temporarily, drug manufacturing plants. That was the case at Ben Venue Laboratories Inc., which last year halted production operations at its headquarters in Bedford after multiple inspections turned up dozens of quality control issues. Ben Venue's shutdown led to a critical shortage of injectable methotrexate, a drug used to treat leukemia in children and rheumatoid arthritis in adults. “It's going to take a long time to figure this out,” said Dr. Michael Anderson, chief medical officer at University Hospitals Case Medical Center, in talking about how to address the shortage. “It'll take a long time to find the right balance between the needs of companies and the needs of patients.” A lobbying effort It wasn't until this summer — thanks to a lobbying effort in Congress led by the Cleveland Clinic — that larger health systems by law could repackage certain drugs into smaller doses and share them among hospitals within their system. Previously, the Clinic only could repackage drugs and share them on its main campus; it was barred, for example, from sharing them with Hillcrest Hospital, just 10 miles east in Mayfield Heights. Still, the Clinic's Mr. Knoer estimates the repackaging legislation will help extend the life of only about 10% of the drugs on short supply. The new provision doesn't apply to controlled substances. It's also unclear how the provision might affect hospitals loosely affiliated with one another, instead of those that are wholly owned. On the plus side, the FDA now requires drug manufacturers to provide six months' advance notice of decisions to discontinue certain drugs, so that hospitals and the market can react accordingly. Such disclosures in the past were voluntary. “This has been a problem that's been brewing for a while,” UH's Dr. Anderson said. “It's reassuring to me as a leader to see the FDA and Congress taking it seriously.” Locally, the Center for Health Affairs, an advocacy group for Northeast Ohio hospitals, has decided to step up its lobbying efforts at the state level after surveying its member hospitals to gauge the breadth of the problem. “The hospitals basically validated that they felt the shortage was somewhat severe,” said Lisa Anderson, a registered nurse and the Center for Health Affairs' vice president of member services. “Years ago, it was sporadic. Now it's more of a chronic problem.” The group is looking to ease restrictions on drug compounding — the method by which drugs are concocted from raw materials at hospitals' in-house pharmacies. At present, the Ohio State Board of Pharmacy permits hospitals to compound drugs on a patient-by-patient basis, rather than stockpile compounded drugs in anticipation of need. State regulations also limit the transfer of compounded drugs between a health system's member hospitals. The Center for Health Affairs also plans to lobby state lawmakers in support of legislation that would forbid pharmacies from selling drugs in short supply to wholesalers, who in turn resell them to hospitals at high markup. The new normal? Hospital officials say it's still too early to tell whether measures to curb the problem will have a lasting impact. Wiggle room, maybe, but a cure-all appears nowhere in sight. “It's bad,” said Stacey Zorska, director of pharmacy at Southwest General Health Center in Middleburg Heights. “It's a daily struggle, and we really can't anticipate what the next crisis is going to be. I think our team has gotten very good at what to do no matter what the shortage is, but it's a struggle.” Kevin Zupancic, director of pharmacy at Parma Community General Hospital, said he's reminded of the shortage daily. He has had to buy a second dry-erase board to keep track in his pharmacy of the mounting list of drugs on short supply. Local hospital officials acknowledge the drug shortages often force them to tweak patients' treatment plans. They said patients haven't been hurt, but the prospect of opting for backup drugs so regularly is a concern. Article found at Crain's Cleveland Business at this page.

Good Manufacturing Practice: A Global Standard for Pharmaceutical Quality

This PowerPoint can be viewed here.

PowerPoint on Contemportary Pharmaceutical Compounding from Dr. Loyd Allen

Here is a PowerPoint Presentation entitled Contemporary Pharmaceutical Compounding from a well-respected expert in the field Dr. Loyd Allen.  To view the PowerPoint can be viewed here.

Powerpoint Presentation on Animal Drug Compounding

Neal Batalier, DVM for the FDA Center for Veterinary Medicine, presented this Powerpoint at the AAVPT 14th.  While it  is dated 2005, it still contains valuable information.  Note, however, that some portions such as those regarding current investigations, etc. are outdated.  To view the Powerpoint, click here.

Coverage of Compounded Medications in Minnesota

Compound Drugs Revised: 01-23-2012 Compound Drugs A compound drug consists of two or more ingredients. The quantity at the line level should reflect the way the NDC is normally billed. Example: if the NDC is normally billed per milliliter, the quantity at the line should be the total number of milliliters dispensed for the entire prescription – not the number of containers of normal saline used. Pharmacies will be paid only for the ingredients which are normally covered by DHS. Commercially Available Products If room stable commercially available products are compounded, reimbursement is limited to the rate of the commercially available product (WAC plus 2% or the SMAC plus dispensing fee). Compounded Products, Preparations, and Oral Drugs Compounded liquid oral drugs (e.g., solutions, suspensions, emulsions) are covered only for children and for aphagic adult recipients, and only when a commercial liquid version of the drug is not available. Compounded capsules are covered only if a tablet or capsule commercial version of the drug is not available in the strength prescribed, and if the appropriate strength cannot be achieved using half or quarter tablets. Compounded Topical Products Compounded topical products are not covered when a product that contains the same combination of active ingredients in the same strengths is commercially available from a pharmaceutical manufacturer, regardless of the package size that is commercially available. Example: If the prescription is for 15 grams of an ointment and the commercially available version is available only in 30 gram tubes, MHCP will not cover 15 grams of the compounded product. Compounded Intravenous (IV) & Total Parenteral Nutritional (TPN) Drugs Compounded IV and TPN drugs are covered according to FDA guidelines regarding approved indications and preparation.

Alabama Medicaid Physician Administered Drugs: When will Compounded Drugs for Non-Pharmacy Providers be Covered

Compound Drugs for Non-Pharmacy Providers
The compound drug must not be commercially available, and the active
ingredient of the compound drug must follow coverage policy of drugs
(FDA approved, non-DESI, not obsolete, etc).
When a provider administers a drug that must be purchased from a
compounding pharmacy because it is no longer commercially available
(e.g. due to the manufacturer no longer marketing the product), the
applicable claim form may be submitted for consideration of payment.  The
billed amount should represent the lesser of the actual acquisition cost for
the drug or Medicaid rate on file (ASP CMS pricing) at the time of service.
When billing the HCPCS code for a purchased compounded drug, only
one NDC can be used per procedure code.  Providers must use the
HCPCS procedure code, billing units and corresponding covered NDC
number on the claim form; for example, J1094 Injection, dexamethasone
acetate, 1 mg.  The NDC billed should be the one that represents the drug
as described in the HCPCS code definition, in this case dexamethasone
acetate.  See the section entitled “Calculation of Billing Units and
Wastage” for information on calculating billing units.
The Agency does not reimburse non-pharmacy providers for prescription
compounding time or non-covered ingredients used in the compounding
process.  The Alabama Medicaid Agency only reimburses for the
compounding time by the billing of NDC numbers through the Pharmacy
Program.

Taken from January 2012 manual found here

Blue Cross Blue Shield of Texas: Information on Compounding

Introduction

Pharmacy Compounding is an ancient practice in which pharmacists combine, mix or alter ingredients to create unique medications that meet specific needs of individual patients. Compounding is a practice that continues to attract the scrutiny of the U.S Food and Drug Administration (FDA) – mainly because of instances where compounded drugs have endangered public health.

The FDA considers virtually all compounded drugs as unapproved new drugs for which safety and efficacy have not been demonstrated with the type of data the FDA requires to approve a new drug. However, the FDA also considers "traditional compounding" to be a valuable service and does not take enforcement action against these practices. The FDA defines traditional compounding as customizing a drug for someone who is allergic to a dye or preservative in an FDA approved medicine, or compounding a liquid dosage form specifically for a younger patient, etc. Compounding does not generally include mixing or reconstituting commercial products in accordance with the manufacturer’s instructions or the product’s approved labeling.

Red Flags and Enforcement Activities by the FDA

The emergence over the past 10-15 years of firms with pharmacy licenses making and distributing unapproved new drugs in a way that is clearly outside the bounds of traditional pharmacy practice is of great concern to the FDA. FDA enforcement has been directed to those pharmacies whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new drug, adulteration, or misbranding provisions of the federal Food, Drug, and Cosmetic Act (FDCA). In addition, unlike commercial drug manufacturers, pharmacies are not required to report adverse events associated with compounded drugs. In a May 2007 consumer newsletter, the FDA reported knowing of more than 200 adverse events involving 71 compounded products since 1990. Examples of some of these adverse events included: three deaths due to contaminated compounded intravenous solutions, and blinding of two patients as well as damaged eyesight to others from a bacterially contaminated compounded product used in cataract surgery. In a 2001 FDA survey of compounded drug products, the agency found 34% of the products tested failed standard quality tests (usually failing potency analyses) as opposed to a less than 2% failure rate for commercially produced drug samples. Examples of medications included in the testing sample included sterile injectables (e.g. dipyridamole, papaverine, phentolamine, etc.), pellet inplants (e.g. estradiol), ophthalmic solutions/ointments (e.g. ciprofloxacin, dexamethasone, timolol, etc.), inhalation (e.g. tobramycin), and oral products (e.g. progesterone, estradiol, etc.). As a consequence, the FDA has issued a number of warning letters to pharmacies that specialize in female hormone products (e.g. ‘Bioidentical hormone replacement therapies’), anti-infective inhalation products, sustained-release/delayed-release/extended-release products, and local anesthetic pain products. FDA Warning Letters have also been sent in cases where the FDA believes pharmacy communications (e.g. advertisements, website information, etc.) contain false and misleading claims about product safety, effectiveness, and superiority to FDA approved and commercially available products. When contemplating further action against compounding pharmacies the FDA considers whether the pharmacy engages in the following acts:

• Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
• Compounding drugs that were withdrawn or removed from the market for safety reasons.
• Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs (e.g. estriol) without an FDA sanctioned investigational new drug application (IND).
• Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA registered facility.
• Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.
• Using commercial scale manufacturing or testing equipment for compounded drug products.
• Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.
• Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.
• Failing to operate in compliance with applicable state law regulating the practice of pharmacy.

The New Texas Health Care Privacy Law (HB 300) and HIPAA/HITECH Compliance: What You Need To Know Now

Registration

Schedule:
Wednesday, September 26, 2012

12PM CENTRAL
(1:00 ET / 10:00 PT / 11:00 MT )
Duration: 60 minutes



$45 for Members
$70 for Non-members

Already Registered?
Refer to confirmation e-mail for connection instructions. 

Tell a Colleague!

Questions?

For immediate assistance please consult our FAQ page. 

If you're unable to find the answer you need, please call 800-701-5161 (M-F, 8am-6pm CT) or e-mail customer service

Summary

This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians. This program has been approved for 1.0 contact hours of continuing education credit (0.1 CEUs). 

Texas Pharmacy Association (154) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been assigned ACPE number 0154-0000-12-012-L03 and is accredited for 1.0 Contact Hours (0.1 CEUs). 

Description: This program will cover existing Texas privacy laws and information on the new legislation. 

At the completion of this program, pharmacists and technicians will be able to:

• Identify the key components and requirements of HIPAA and the new Texas health care privacy law for Texas pharmacists, pharmacy technicians, pharmacies and other Texas entities.
• Appraise the significance of pharmacy accountability and potential enforcement, audit, and civil penalty consequences for privacy breaches.
• Comply with federal and state privacy and security laws, regulations and rules for the protection of identifiable protected health information.

For more information on this seiminar click here.

Texas Pharmacy Association Pharmacy Law Symposium

Texas Pharmacy Association 
presents: 

Texas Pharmacy Law Symposium

This program is for pharmacists.

This program is aimed at giving pharmacy professionals a better understanding of Texas and Federal drug laws. Students & reciprocating pharmacists should take this program to prepare for the state law exam.

When:Saturday - February 16, 2013
Where: Texas Association of School Boards (TASB) Building, 12007 Research Blvd., Austin, TX 78759
CLICK HERE to view a list of area hotels. 

If you need to take the course prior to this date, click here to view TPA's online Texas Pharmacy Law Symposium.

Learning Objectives: 
Upon completion of this program, participant will be able to:

1. Identify the major provisions of the federal Food, Drug and Cosmetic Act that relate to the practice of pharmacy.
2. Compare and contrast the requirements of the federal Controlled Substances Act and the Texas Controlled Substances Act.  
3. Distinguish between dispensing and distribution of controlled substances and the record-keeping requirements for each.
4. Describe the legal requirements for dispensing prescriptions for controlled substances, dangerous drugs and non-prescription medicines. 
5.  Explain the Texas Drug Product Substitution Act.
6. Explain the requirements for pharmacist and pharmacy licenses in Texas. 

Agenda:

  8:00 a.m. – 12:00 p.m.:    Law Review program
12:00 p.m. –   1:00 p.m.:    Lunch break
  1:00 p.m. –   5:30 p.m.:    Law Review program / Q&A
 

For more information, click here.

Oklahoma Pharmacy Association 2012 Law Seminar

2012 OPhA Law Seminar

Please join us for our annual 2012 Law Seminar to be held on Sunday, December the 2nd from 8:00 am - 5:00pm at the OU College of Pharmacy in Oklahoma City. This program is intended for pharmacists, regardless of their practice setting who wish to increase and enhance their knowledge and skills as they relate to their knowledge of Oklahoma law. Our guest speakers include professionals from an array of law related backgrounds. I believe you'll find this eight hour program greatly informative. 

 

For more information cleck here.

Blue Cross position in Michigan regarding compounded drugs

August 2012

Compounded prescriptions covered only if all ingredients covered

Beginning Aug. 1, 2012, for Blue Cross Blue Shield of Michigan commercial (non-Medicare) customers and Sept 1, 2012, for Blue Care Network commercial (non-Medicare) customers, when a customer fills a prescription for a compounded drug, each ingredient in the compound must be covered under the member’s plan in order for the prescription to be payable. If a compound contains a product that is not covered under the member’s plan, even if it has been covered for a member in the past, the claim will now be rejected.

All other pharmacy benefit exclusions and limitations will also apply to compounds, including off-label exclusions, quantity limits for drugs used for erectile dysfunction and exclusions for both cosmetic use and bulk chemicals. Some exceptions exist for select over-the-counter products used as compound vehicles. Please discuss alternatives with your patients.

If you have questions about these changes, please call the Pharmacy Services Clinical Help Desk at
1-800-437-3803 and follow the prompts to reach the BCBSM or BCN prior authorization line.

Members who would like more information about any of their prescription drug benefits can be directed to call the customer service number on the back of their Blues ID cards.

NY judge tosses convictions in Fla. steroids case

The Associated Press

Published: Saturday, September 1, 2012 at 12:54 p.m.

Last Modified: Saturday, September 1, 2012 at 12:54 p.m.

ALBANY, N.Y. - A judge has delivered another blow to a New York prosecutor's attempt to prosecute Floridians for selling steroids, including people connected to an Orlando pharmacy that played a role in baseball's juicing scandals.

Albany Judge Stephen Herrick this week threw out the convictions of two men who had pleaded guilty in 2007 to funneling fraudulent prescriptions from their clinic in Davie, Fla., to Signature Compounding Pharmacy.

The judge ruled that prosecutors had waited too long to get Greg Trotta and Brian Schafler sentenced.

The Times Union reported ( http://bit.ly/S8Cxvn) that the men had been cooperating with the Albany District Attorney and had been expected to get probation, but their case kept getting delayed as prosecutors battled with the judge over their ability to press charges against Signature's owners.

---

Information from: Times Union, http://www.timesunion.com

Horse racing: Doping detection stays a neck ahead

Whilst the eyes of the world may currently be focused on the Olympics, human sport is not the only area where drug testing is routinely carried out.

Horse racing is a massive world-wide industry, and regular testing is essential to maintain its integrity.

As with human sport, the authorities constantly need to develop methodologies to detect new compounds that drug cheats are using or may start to use.

Read more ...

Powerpoint Presentation Regarding Use of Non-Pharmaceutical-Grade

Authored and Presented by Patricia Brown, VMD, MS, DACLAM Director, OLAW, NIH
Carol Clarke, DVM, DACLAM Staff Officer, AC, APHIS, USDA, Christian Newcomer, VMD, DACLAM Executive Director, AAALAC International presented at the OLAW Online Seminar
March 1, 2012

To view the Powerpoint click here.