Note of Interest: In 1997 When Bayer sued Eaton Veterinary Laboratories in Federal Court for Trademark Infringement--Eaton was owned by Galleon One Inc. D/B/A Easton Veterinary Laboratories. This is a another reason for more transparency, something this blog has advocated since its beginning. Consumers of compounding medications would not know that when researching Roadrunner they would also need to look under multiple other names to find information.

U.S. District Court
Western District of Missouri (Kansas City)
CIVIL DOCKET FOR CASE #: 4:97-cv-00194-ODS

Bayer Corporation v. Galleon One Inc Assigned to: Judge Ortrie D Smith Demand: $0 Cause: 15:1125 Trademark Infringement (Lanham Act)

Date Filed: 02/20/1997 Date Terminated: 12/23/1998 Jury Demand: None Nature of Suit: 840 Trademark Jurisdiction: Federal Question

Plaintiff
Bayer Corporation	represented by	Jack D Rowe  Lathrop & Gage LLP - KCMO 2345 Grand Avenue Suite 2200 Kansas City, MO 64108-2618 (816)292-2000 Fax: (816)292-2001 Email: jrowe@lathropgage.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Ronald C. Provenzano  Kirkland & Ellis 200 East Randolph Drive 60th Floor Chicago, IL 60601 312-861-2000 LEAD ATTORNEY ATTORNEY TO BE NOTICED Jennifer Anderson Van Kirk  Kirkland & Ellis 200 East Randolph Drive 60th Floor Chicago, IL 60601 312-861-2000 ATTORNEY TO BE NOTICED Tefft W. Smith  Kirkland & Ellis 200 East Randolph Drive 60th Floor Chicago, IL 60601 312-861-2000 ATTORNEY TO BE NOTICED William A. Rudy  Lathrop & Gage LLP - KCMO 2345 Grand Avenue Suite 2200 Kansas City, MO 64108-2618 (816) 292-2000 Fax: (816) 292-2001 Email: wrudy@lathropgage.com ATTORNEY TO BE NOTICED
V.
Defendant
Galleon One Inc doing business as Eaton Veterinary Laboratories	represented by	Gerald M. Kraai  Lathrop & Gage LLP - OPKS 10851 Mastin Boulevard Building 82 Suite 1000 Overland Park, KS 66210-2007 (913) 451-5100 Fax: 913-451-0875 Email: gkraai@lathropgage.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Michael Elbein  Hovey Williams LLP 10801 Mastin Ste. 1000 Overland Park, KS 66210 (913) 647-9050 Fax: (913) 647-9050 Email: mme@hoveywilliams.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Michael W. Sillyman  Kutak Rock 3300 N. Central, 16th Fl. Phoenix, AZ 85012 (602) 285-1700 TERMINATED: 07/21/1997 LEAD ATTORNEY ATTORNEY TO BE NOTICED Peggy D. Richardson  Moniteau County Courthouse 200 E. Main California, MO 65018 (573) 796-4671 TERMINATED: 07/18/1997 ATTORNEY TO BE NOTICED

Date Filed	#	Docket Text
02/20/1997	1	COMPLAINT w/JS44 ( 1 Summons(es) issued) Receipt # 128432 $150.00 pd (Shannon Brogan) (Entered: 02/20/1997)
02/20/1997	2	Notice of Control Group Assignment (Early Assessment Program) (Shannon Brogan) (Entered: 02/20/1997)
03/04/1997	3	RETURN OF SERVICE executed upon defendant Galleon One Inc on 2/27/97 Costs $ 257.15 (Court Employee) (Entered: 03/05/1997)
03/06/1997	4	Motion/Order for pro hac vice on behalf of Bayer Corporation by Ronald C. Provenzano Receipt #: 128688 in the amount of $25.00 (Susan Larson) (Entered: 03/07/1997)
03/06/1997	5	Motion/Order for pro hac vice on behalf of Bayer Corporation by Jennifer A. Anderson Receipt #: 128688 in the amount of $25.00 (Susan Larson) (Entered: 03/07/1997)
03/06/1997	6	Motion/Order for pro hac vice on behalf of Bayer Corporation by Tefft W. Smith Receipt #: 128688 in the amount of $25.00 (Susan Larson) (Entered: 03/07/1997)
03/14/1997	7	Motion/Order for pro hac vice on behalf of Galleon One Inc by Michael W. Sillyman Receipt #: #128852 in the amount of $25.00 (Susan Larson) (Entered: 03/14/1997)
03/18/1997	8	MOTION by defendant Galleon One Inc to dismiss , or in the alternative to transfer case to the District of Arizona (Susan Larson) (Entered: 03/19/1997)
03/26/1997	9	MOTION by plaintiff Bayer Corporation to extend time to respond to dft's motion to dismiss and for leave to depose Robert L. Eaton Jr (Susan Larson) (Entered: 03/26/1997)
04/03/1997	10	Response by defendant Galleon One Inc to plt's motion to extend time to respond to dft's motion to dismiss [9-1], plt's motion leave to depose Robert L. Eaton Jr [9-2] (Susan Larson) (Entered: 04/03/1997)
04/08/1997	11	ORDER by Judge Ortrie D. Smith granting dft's motion to extend time to respond to dft's motion to dismiss [9-1], granting motion for leave to depose Robert L. Eaton Jr [9-2]; plf shall have 30 days from the date of this order to file a response to dft's motion to dismiss (cc: all counsel) (Georgia Kee) (Entered: 04/09/1997)
04/08/1997	12	ORDER by Judge Ortrie D. Smith ; proposed scheduling order due on or before 5/29/97 ;rule 26(f) meeting on or before 5/19/97 (cc: all counsel) (Georgia Kee) (Entered: 04/09/1997)
04/21/1997	13	Notice by plaintiff Bayer Corporation of filing compliance statement (Court Employee) (Entered: 04/22/1997)
05/06/1997	14	MOTION by defendant Galleon One Inc to vacate , or, alternatively to stay the Court's order setting deadline f/filing of joint proposed scheduling order & f/Rule 26(f) Conference (Georgia Kee) (Entered: 05/06/1997)
05/06/1997	15	1st AMENDED COMPLAINT Number of summon(s): 0 (Georgia Kee) (Entered: 05/07/1997)
05/20/1997	17	Suggestions by plaintiff Bayer Corporation in opposition to motion to vacate [14-1], motion to stay the Court's order setting deadline f/filing of joint proposed scheduling order & f/Rule 26(f) Conference [14-2] (Georgia Kee) (Entered: 05/20/1997)
05/22/1997	18	Reply suggestions by defendant Galleon One Inc to motion to dismiss [8-1], motion to transfer case to the District of Arizona [8-2] (Georgia Kee) (Entered: 05/22/1997)
05/27/1997	19	Reply suggestions in support of its by defendant Galleon One Inc to motion to vacate [14-1], motion to stay the Court's order setting deadline f/filing of joint proposed scheduling order & f/Rule 26(f) Conference [14-2] (Georgia Kee) (Entered: 05/27/1997)
06/03/1997	20	Suggestions by plaintiff Bayer Corporation in opposition to motion to dismiss [8-1] (Georgia Kee) (Entered: 06/04/1997)
06/03/1997	21	Report of Parties' Rule 26 Disclosure by plaintiff Bayer Corporation, defendant Galleon One Inc (Georgia Kee) (Entered: 06/04/1997)
06/16/1997	22	CERTIFICATE by defendant Galleon One Inc of service of Rule 26(A)(1)) Initial Disclosures (Georgia Kee) (Entered: 06/17/1997)
06/18/1997	23	Reply suggestions by defendant Galleon One Inc to motion to dismiss [8-1] (Georgia Kee) (Entered: 06/18/1997)
06/20/1997	24	ENTRY OF APPEARANCE on behalf of defendant Galleon One Inc by Michael Elbein, Gerald M. Kraai (Georgia Kee) (Entered: 06/20/1997)
06/30/1997	25	MOTION by defendant Galleon One Inc to withdraw attorney Peggy D. Richardson (Georgia Kee) (Entered: 06/30/1997)
07/07/1997	26	CERTIFICATE by plaintiff Bayer Corporation of service of 1st req to produce docs (Georgia Kee) (Entered: 07/08/1997)
07/07/1997	27	CERTIFICATE by plaintiff Bayer Corporation of service of 3rdpty subpoenas served on George Darnell, Dennis Darnell, Dr. Choi, Dr. Steve Kennedy, Dr. Paul Toogood, Dr. James K. Waldsmith, Dr. Banez, Dr. Ken Baker, Sprint Intl Comm Corp & US West Inc (Georgia Kee) (Entered: 07/08/1997)
07/16/1997	28	MOTION by defendant Galleon One Inc to withdraw attorney Michael W. Sillyman (Georgia Kee) (Entered: 07/17/1997)
07/16/1997	29	CERTIFICATE by plaintiff Bayer Corporation of service of subpoena in a civil case (Susan Larson) (Entered: 07/17/1997)
07/17/1997	30	CERTIFICATE by defendant Galleon One Inc of service of 1st request for production of documents (Susan Larson) (Entered: 07/18/1997)
07/18/1997	31	ORDER by Judge Ortrie D. Smith granting motion to withdraw attorney Peggy D. Richardson [25-1] attorney Peggy D. Richardson for Galleon One Inc (cc: all counsel) (Georgia Kee) (Entered: 07/21/1997)
07/21/1997	32	ORDER by Judge Ortrie D. Smith granting counsel f/dft's motion to withdraw attorney Michael W. Sillyman [28-1] attorney Michael W. Sillyman for Galleon One Inc (cc: all counsel) (Georgia Kee) (Entered: 07/21/1997)
07/30/1997	33	CERTIFICATE by defendant Galleon One Inc of service of Response to plf's req f/prod of docs (Georgia Kee) (Entered: 07/30/1997)
08/08/1997	34	ORDER by Judge Ortrie D. Smith denying dft's motion to dismiss [8-1] denying dft's motion to transfer case to the District of Arizona [8-2] (cc: all counsel) (Georgia Kee) (Entered: 08/08/1997)
08/08/1997	35	SCHEDULING & TRIAL ORDER: by Judge Ortrie D. Smith ; discovery ddl set 3/31/98;final pretrial conference set for 9:00 a.m. on 7/24/98 ;jury trial set 9:00 a.m. on 8/24/98 (cc: all counsel) (Georgia Kee) (Entered: 08/08/1997)
08/08/1997	36	RULES of trial by Judge Ortrie D. Smith (Georgia Kee) (Entered: 08/08/1997)
08/11/1997	37	Stipulation for entry of protective order of plaintiff Bayer Corporation, defendant Galleon One Inc (Georgia Kee) (Entered: 08/12/1997)
08/13/1997	38	PROTECTIVE ORDER by Judge Ortrie D. Smith : granting stipulation [37-1]; see order f/further details (cc: all counsel) (Georgia Kee) (Entered: 08/13/1997)
08/21/1997	39	ANSWER by defendant Galleon One Inc to 1st amd cmp (Georgia Kee) (Entered: 08/22/1997)
09/05/1997	40	CERTIFICATE by plaintiff Bayer Corporation of service of 1st req f/prod of docs (Georgia Kee) (Entered: 09/08/1997)
11/03/1997	41	CERTIFICATE by plaintiff Bayer Corporation of service of 3rd pty subpoenas & notices of depo (Georgia Kee) (Entered: 11/04/1997)
11/04/1997	42	CERTIFICATE by plaintiff Bayer Corporation of service of req to produce supplemental documents (Georgia Kee) (Entered: 11/05/1997)
11/12/1997	43	CERTIFICATE by plaintiff Bayer Corporation of service of Request to produce things (Georgia Kee) (Entered: 11/13/1997)
11/13/1997	44	CERTIFICATE by plaintiff Bayer Corporation of service of notice of deposition (Susan Larson) (Entered: 11/14/1997)
11/17/1997	45	CERTIFICATE by defendant Galleon One Inc of service of Response to Bayer's Supplemental Req f/prod of docs (Georgia Kee) (Entered: 11/18/1997)
12/08/1997	46	CERTIFICATE of transmission of deposition of Jae Choi, D.V.M. taken on 11/19/97 on behalf of plaintiff Bayer Corporation Costs: $249.55 (Court Employee) (Entered: 12/08/1997)
12/12/1997	47	CERTIFICATE by defendant of service of resp to pla's 3rd req f/prod ofdocus (Court Employee) (Entered: 12/12/1997)
12/17/1997	48	ORDER by Judge Ortrie D. Smith it is ordered that the Scheduling & Trial order dated 8/8/97 be struck & the court proceedings by stayed until 6/15/98; on or before 6/15/98, the parties shall file a joint status report informing the Court whether this case should be rescheduled for trial (cc: all counsel) (Georgia Kee) (Entered: 12/17/1997)
12/24/1997	49	CERTIFICATE of transmission of deposition of George W. Darnell taken on 11/21/97 on behalf of plaintiff Bayer Corporation Costs: $257.95 by pd plf (Georgia Kee) (Entered: 12/24/1997)
12/29/1997	50	CERTIFICATE of transmission of deposition of Sandra Tye taken on 12/9/97 on behalf of plaintiff Bayer Corporation Costs: $185.85 pd by plf (Georgia Kee) (Entered: 12/29/1997)
03/05/1998	51	NOTICE by defendant Galleon One Inc of change of address (Georgia Kee) (Entered: 03/06/1998)
06/12/1998	52	Joint Written status report by plaintiff Bayer Corporation, defendant Galleon One Inc (Georgia Kee) (Entered: 06/12/1998)
06/19/1998	53	SCHEDULING & TRIAL ORDER: by Judge Ortrie D. Smith ; discovery ddl set 12/31/98 ;pretrial conference 10:00 a.m. on 4/30/99 ;jury trial set 8:30 a.m. on 6/14/99 (cc: all counsel) (Georgia Kee) (Entered: 06/22/1998)
08/20/1998	54	CERTIFICATE by plaintiff Bayer Corporation of service of Supplement Responses to its 1st req to produce docs (Georgia Kee) (Entered: 08/20/1998)
08/24/1998	55	CERTIFICATE by plaintiff Bayer Corporation of service of 1st set of Interr to dft (Georgia Kee) (Entered: 08/25/1998)
09/14/1998	56	CERTIFICATE by plaintiff Bayer Corporation of service of Protective Order (Georgia Kee) (Entered: 09/15/1998)
09/22/1998	57	CERTIFICATE by defendant Galleon One Inc of service of req f/prod of supplemental docs (Georgia Kee) (Entered: 09/22/1998)
09/24/1998	58	MOTION by defendant Galleon One Inc to extend time to respond to plf's 1st set of Interr (Georgia Kee) (Entered: 09/24/1998)
09/29/1998	59	CERTIFICATE by plaintiff Bayer Corporation of service of 30(b)(6) deposition of dft (Georgia Kee) (Entered: 09/30/1998)
10/01/1998	60	CERTIFICATE by defendant Galleon One Inc of service of Responses to plf's 1st set of Interr (Georgia Kee) (Entered: 10/01/1998)
10/05/1998	61	ORDER by Judge Ortrie D. Smith granting dft's motion to extend time to respond to plf's 1st set of Interr [58-1] up to & including 9/30/98 (cc: all counsel) (Georgia Kee) (Entered: 10/06/1998)
10/20/1998	62	Request w/dft's consent by plaintiff Bayer Corporation for an extension of time to designate experts & file expert affidavits w/suggs in support (Georgia Kee) (Entered: 10/21/1998)
10/26/1998	63	CERTIFICATE by defendant Galleon One Inc of service of 1st set of Interr (Georgia Kee) (Entered: 10/26/1998)
10/26/1998	64	ORDER by Judge Ortrie D. Smith granting request that the time set for the exchange of expert witness designations & affidavits are modified [62-1] (cc: all counsel) (Georgia Kee) (Entered: 10/26/1998)
11/20/1998	65	(REQUEST) MOTION by plaintiff Bayer Corporation to extend time to respond to dft's 1st set of Interr (Georgia Kee) (Entered: 11/23/1998)
11/24/1998	66	CERTIFICATE by defendant Galleon One Inc of service of 2nd set of Interr & 1st req f/admission to plf (Georgia Kee) (Entered: 11/24/1998)
12/01/1998	67	ORDER by Judge Ortrie D. Smith granting plf's motion to extend time to respond to dft's 1st set of Interr [65-1] to & including 12/7/98 (cc: all counsel) (Georgia Kee) (Entered: 12/02/1998)
12/03/1998	68	MOTION by plaintiff Bayer Corporation to extend time to respond to dft's 1st set of interros (Court Employee) (Entered: 12/03/1998)
12/08/1998	69	ORDER by Judge Ortrie D. Smith granting plf's motion to extend time to respond to dft's 1st set of interros [68-1] up to & including 12/16/98 (cc: all counsel) (Georgia Kee) (Entered: 12/09/1998)
12/23/1998	70	ORDER by Judge Ortrie D. Smith this action is hereby dismissed w/prejudice to dismiss case (cc: all counsel) (Georgia Kee) (Entered: 12/24/1998)

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Fourth Question of the Day October 1, 2013 Does having a degree in interior design, nursing and culinary arts and being the owner of a boutique qualify someone to own a veterinary compounding pharmacy or to make veterinary compounded medications? Should animal owners be more aware of who the makers and owners of veterinary compounding pharmacies are? Should there be requirements as has been suggested on the blog before that veterinary compounding pharmacies be a speciality in pharmacy schools and special licenses be required to make these types of compounded preparations?

Linda Obele

Phoenix Business Journal

Bold businesswoman builds ode to girliness

Sabrina Eaton always has enjoyed wearing different hats -- which makes sense, considering she owns a north Phoenix boutique that features more than 3,000 square feet of accessories and fashion items. But when she talks about wearing many hats, she could just as easily be discussing her varied business interests.

"I've always been very curious about a lot of things," said Eaton, owner of Sabrina's Boutique at Seventh Street and the Carefree Highway. "And I've always loved a challenge. If something interests me, I just go for it."

Her formal education includesdegrees in interior design, nursing and culinary arts. She's worked as an interior designer, a nurse and owner of a medical lab/pharmacy.

In 1995, Eaton and her husband, Robert, decided to capitalize on her medical training by founding Eaton Labs and Road�Runner Pharmacy, which customized medications for people and animals. She still runs both the lab and the pharmacy, and is working to secure a patent for a medication that treats dry eyes in pets.

Three years ago, realizing they had outgrown their quarters, the Eatons designed and built Tuscani Pointe, a 90,000-square-foot retail center that houses the lab, the pharmacy and Sabrina's Boutique, her ode to girliness.

For more: www.sabrinasboutiqueaz.com.

quoted from here

Third Question of the Day October 1, 2013 Is there Really this Much Money Being Made in the Veterinary Pharmaceutical and Compounding Industry? Eaton Veterinary Pharmaceutical, Inc. d/b/a Roadrunner Pharmacy Revenue is $27 million

Eaton Veterinary Pharmaceutical, Inc.

711 East Carefree Highway Suite 140 , Phoenix , AZ , 85085 , United States

www.roadrunnerpharmacy.com

Phone: +1 623 434 1180

Revenue: $27M

Industry: Pharmaceuticals - Diversified

Employees: 35

SIC: Drugs (2830)

NAICS: In-Vitro Diagnostic Substance Manufacturing (325413)

Description:Eaton Veterinary Pharmaceutical, Inc., doing business as Roadrunner Pharmacy, operates veterinary compounding pharmacies. It specializes in compounding back-ordered and discontinued veterinary medications for veterinarians and their patients in the United States. The company was founded in 1999 and is based in Phoenix, Arizona.

2013-07-20 06:35:36

Contacts - VIEW DETAILS

GM/Managing Director(s)

Becky Sheehan, General Manager

Director(s)

Bruce Dell, Director of Business Development

Other

David Parker, Director

Roadrunner Pharmacy (Formerly Eaton VeterinaryPharmaceutical, Inc.) 

Second Question of the Day October 1, 2013 Does this type of illegal activity still occur in the veterinary or animal medication world? Does the EPA or State Agriculture Agencies Still Get Involved?

News Releases By Date

EATON VETERINARY LAB (also known as Roadrunner) ORDERED TO STOP SELLING ILLEGAL PET PRODUCTS

Release Date: 2/9/2000

Contact Information: Paula Bruin, U.S. EPA, (415) 744-1587

SAN FRANCISCO -- The U.S. Environmental Protection Agency today issued Stop Sale Orders against Eaton Veterinary Laboratories of Phoenix, Ariz., for selling unregistered flea products. The company sold and distributed unregistered versions of the popular flea-control products "Advantage for Dogs," "Advantage for Cats," "Frontline Top Spot Cat," and "Frontline Top Spot Dog."

Both Advantage and Frontline products are missing required labeling information about how to use the products safely. The unregistered Frontline pet products must include the warning that children are prohibited from applying the product. Also missing from the label is the restriction that the product must not be reapplied for 30 days. The unregistered Advantage pet products are missing language on the label about First Aid instructions and storage and disposal requirements.

The EPA will not register a pesticide until it has been tested to show that it will not pose an unreasonable risk when used according to the directions. The Agency also makes sure that pesticide labels provide consumers with the information they need to use the products safely. Pesticide products that have undergone this review process are recognizable by the EPA registration number printed on the label.

There has been a recent increase in the number of companies bringing unregistered pet products into the United States. Last year EPA assessed a fine against a San Diego pet store for selling unregistered Advantage for Dogs and Advantage for Cats. Also, a Stop Sale Order was issued to a distributor for importing unregistered Advantage products from Mexico with Spanish labeling.

The EPA's Action today was based on inspections conducted by Arizona Department of Agriculture and Virginia Department of Agriculture and Consumer Services.

Legislation defines when FDA can take action against compounders October 1, 2013 | By Eric Palmer

This week, Congress is expected to firm up FDA authority over compounding pharmacies like the one tied to last year's fatal outbreak of fungal meningitis. It will also give it stepped-up authority over those compounders that see enough market advantage that they volunteer to be regulated and pay a $15,000-a-year fee for the privilege.

"The question is, why would anybody ask for that? The answer is that 90% of hospitals outsource some of their compounding, and we hope that they will elect to buy from those facilities that operate under FDA oversight and those higher standards," explained Allan Coukell, a drug-policy expert at the Pew Charitable Trusts, which supports the legislation. "I think some will do it."

Read more: Legislation defines when FDA can take action against compounders - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/legislation-defines-when-fda-can-take-action-against-compounders/2013-10-01#ixzz2gVoyzD4d
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Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs OCTOBER 1, 2013 BY PATRICK STONE

The FDA’s “Food Police” will be in full force to secure budget funds for food safetyinitiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

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FDA Finds Fungus in Nasal Solution

Tue, 10/01/2013 - 2:31pm

The U.S. Food and Drug Administration is alerting patients and health care providers that budesonide solution, which is used for nasal irrigation, from The Compounding Shop in St. Petersburg, Fla., may be contaminated and should not be used or administered to patients.

 

FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market.

 

Drug products that are for oral inhalation— such as the budesonide solution from the Compounding Shop, which is labeled “for inhalation only”— are required to be sterile. Contaminated drug products, whether used by inhalation or otherwise, put patients at risk for infection. Patients and health care providers who have this product on hand should not use it.

 

The budesonide solution from the Compounding Shop is also labeled for nasal irrigation, which may be confusing to consumers.

Congress Speaks Up for Community Pharmacies’ Compounding Services Published October 1, 2013

By Kevin Schweers

Three days before today’s government shutdown produced by partisan gridlock, Republicans and Democrats came together to approve drug safety legislation and re-affirm their support for compounding services provided by independent community pharmacies.

On a voice vote, the House of Representatives approved H.R. 3204, The Drug Quality and Security Act, legislation endorsed by NCPA, that responds to the tragic 2012 meningitis outbreak and adopts supply chain protections. The legislation is currently awaiting approval by the Senate. In the debate preceding the vote, lawmakers discussed how the bill protects community pharmacies’ ability to continue to compound drugs for their patients and asserted their intent to monitor its implementation to ensure it does not inadvertently infringe upon long-accepted compounding pharmacy practices.

“Mr. Speaker, this bill upholds the current section 503(a) of the law, and provides it with the clarity that FDA needs by eliminating the unconstitutional provisions,” said House Energy and Commerce Committee Chair Fred Upton (R-Mich.). “The bill also requires FDA to engage in meaningful communication with State boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That’s why the bill has the support of the National Community Pharmacists Association, and I would like to thank them for working with us so closely.”

Health Subcommittee Chair Joe Pitts (R-Penn.) opened his remarks noting that, “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak – one of the largest public health crises in recent memory.” He also cited NCPA as one of the bill’s supporters, among other industry groups.

From the Democratic side of the aisle, Health Subcommittee Ranking MemberFrank Pallone (D-N.J.) added that, “The bill will permit compounders who wish to practice outside the scope of traditional pharmacy to register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated as they are under current law.”

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HRT Risks May Vary by Type of Estrogen Drug Published: Sep 30, 2013 | Updated: Oct 1, 2013

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From the FDALAW Blog--September 30, 2013 National Rx Track and Trace System Could Soon Be a Reality – House Passes HR 3204 By William T. Koustas & Jessica A. Ritsick –

With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, and here).  The House passed a bill in June, H.R. 1919, that would create a national pedigree system and the Senate Committee on Health, Education, Labor, and Pensions (“the Senate Committee”) passed a similar bill, S. 959, in May.  Then, late on September 25, 2013, leaders from the Senate and House committees overseeing health care policy announced that they reached an agreement on bipartisan and bicameral legislation (“bicameral legislation”) that would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to address compounding pharmacies and incorporate a national prescription drug track and trace system as well as national standards for prescription drug wholesale distributors (“wholesalers”) and third-party logistics providers (“3PLs”).  The House passed the bicameral legislation, the Drug Quality and Security Act (H.R. 3204), on September 28, 2013 by voice vote.  A detailed outline of the bicameral legislation prepared by Hyman, Phelps & McNamara, P.C. can be found here.

The track and trace system (i.e., pedigree) set forth in the bicameral legislation would preempt state pedigree requirements and eventually create a national interoperable electronic prescription drug track and trace system.  While the bicameral legislation is in many respects similar to the Senate Committee’s bill, it contains some significant differences.

The bicameral legislation provides specific track and trace requirements for manufacturers, wholesalers, repackagers, and dispensers (e.g., pharmacies) of prescription drugs.  Unlike the Senate Committee’s bill, it does not require 3PLs to be responsible for pedigrees.  Under the bicameral legislation, manufacturers would be required to include a product identifier number on each “package and homogeneous case” of prescription drug product they produce within four years of enactment, while repackagers would be required to include it within five years.    In the meantime, the bicameral legislation requires manufacturers, wholesalers, repackagers, to provide and/or receive pedigree by January 1, 2015, while dispensers are required to do so by July 1, 2015.  In addition, wholesalers would be required to accept and distribute only those prescription drug products that include product identifiers within six years, while dispensers would be required to only receive proscription drug products with a product identifier within seven years.  As such, other than for 3PLs, the timelines for incorporating and distributing drug products with a product identifier for manufacturers, wholesalers, dispensers, and repackagers remains unchanged from the earlier Senate Committee’s bill.

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US Senator Bennet Joins HELP Committee Colleagues Calling for Senate Passage of Drug Quality and Security Act

Bennet’s Bipartisan Track-and-Trace Bill Included in Proposal

September 30, 2013

Colorado U.S. Senator Michael Bennet joined a bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators to applaud the House passage of a bill to track all prescription drugs from the point they are manufactured to the drug store and to provide better oversight of compounding pharmacies.  The senators urged their colleagues to pass a companion measure that passed the House of Representatives on Saturday.

The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address these drug safety and security issues.  The drug supply chain security provisions are based off of Bennet’s Drug Supply Chain Security Act he introduced with Senator Richard Burr (R-NC) in May after working to find consensus over the last two years. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of the Prescription Drug Marketing Act.

In addition to Senator Bennet, the bill was introduced by HELP Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and Senators Al Franken (D-MN), Pat Roberts (R-KS), and Burr.

“If fruit growers in Colorado can track a peach from the tree to the grocery store, we should be able to monitor prescription drugs in a similar way,” Bennet said.  “Whether it is through a stronger supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from any potential health risks.  Now that the House has passed this bill, we will work to get it passed quickly in the Senate and sent to the President for his signature.”

Drug Supply Chain Security

Sen. Bennet, Sen. Burr, Chairman Harkin, and Ranking Member Alexander, have developed track and trace legislation that improves patient safety by replacing today’s patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.  This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.

Among other highlights, the legislation:

• Develops a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto key information about each drug’s distribution history.  Within ten years, supply chain stakeholders will participate in electronic, interoperable product tracing.
• Strengthens licensure requirements for wholesale distributors and third-party logistics providers.  Wholesale distributors will have higher standards for their licenses nationwide, and third-party logistics providers will be recognized for the first time as a part of the drug supply chain. FDA will also keep a database of wholesalers that will be available to the public through the FDA’s website, allowing consumers and members of the drug supply chain to identify appropriately licensed wholesalers.
• Establishes nationwide drug serial numbers.  Four years after the date of enactment, manufacturers will serialize drugs in a consistent way across the industry.  This will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.

Compounding Oversight

One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs.  Following the outbreak, a bipartisan group of HELP Committee Senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Franken, and Sen. Roberts—developed legislation to help ensure that quality compounded drugs are available to patients who need them.

Among other highlights, the legislation:

• Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
• Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
• Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
• Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.

Question of the Day October 1, 2013, Is anyone including Congress, the FDA, and State Boards of Pharmacy, paying attention to what is going on in the compounding pain medication world? The discussion on CafePharma board is very telling.

ny pain reps looking to make 10K to 40K per month on the side?

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With all the connections you Pfizer reps have and are paid so little in comparison to the huge revenue I was just wondering if any of you would be interested in earning an extra 10K to 40K per month? Our company not only has a compounding pharmacy that you can promote but also 2 additional services that our reps promote with one being the industry leader in Genetic DNA testing via oral swab. The need for personalized medicine is growing rapidly and physicians are looking for genetic help to pick which medication is right or wrong for a patient and what dose they should start them on. The third service is a drug testing confirmation lab.
The real money maker for most reps in the compounding pharmacy which is why the industry is exploding right now. Everyone has seen Voltaren Gel promoted in your offices and it only has one active ingredient which is Diclofenac with a 1% concentration. Our pharmacy combines an NSIAD like Diclofenac but with at least a 3% concentration along with many other active ingredients to offer a product that typically offers much better pain reduction and is applicable to many more conditions and patients. Doesn't it make perfect sense that if you take that NSAID along with a muscle relaxer, a neuropathic pain med like Gabapentin, and throw in a topical anesthetic that you could treat a wide range of pain patients? Considering that we have meds to treat wounds and scar and that the aver reimbursement is around $1,800 per script and a rep earning 20% to 24% commission you can see why we had a rep work 4 hours in their first week working just Thursday & Friday and earned $2,500 off of 3 physicians. When they went back on Monday the physician had already written 7 new scripts so they could easily end up earning about 11K this week. If you consider that we pay a commission on every scripts whether it is a new RX or a refill you can see why reps are earning 10K to 40K per month. If you can find 20 physicians to write just 1 script per week you should earn about 28K per month. Keep in mind that those do not have to be new scripts, that could be 10 physicians who wrote 1 script per week last month and those patients got refills and you are right back at 20 scripts per week. When you factor how many scripts you might get in the third month you see why this is so attractive. You are a 1099 rep which means you are your own boss with no reports to turn in, no one micromanaging you, you can be at the beach every day and never make another sales call but if your physicians keep sending in scripts we keep paying you month after month year after year. Let's just say that there are a lot of reps both pharmaceutical and medical device that are finally jumping up in the morning excited about going to work as they finally are getting to work for themselves. Big pharma always talks about taking ownership and running the territory like you own it but they never pay you like you own it. You never have any quotas or sales number to hit and it’s the best residual income you will ever earn. The biggest hurdle reps have it getting past their concern that this is real and not some scam but it doesn't take much research to find out this industry is exploding. If you are interested you can go to our website at www dot SupremeMedSolutions dot com or you can email me at tisley at chartertn dot net. We offer the highest commission in the industry and multiple products you can sell and earn that high residual income on. What have you got to lose in finding out a little more info?

Quoted from CafePharma Board found here

DeGette Lauds House Passage of Compounding Drug Bill

view on youtube 

Editorial: Put teeth back in compounding pharmacy bill-If it walks like “big pharma,” it ought to be regulated like “big pharma.”

By South Jersey Times 
on October 01, 2013 at 5:30 AM, updated October 01, 2013 at 5:37 AM

Amid the weekend jockeying to avoid a federal government shutdown over “Obamacare,” and the eve of the health care law’s enrollment period, lawmakers didn’t completely forget another medical issue.
Saturday’s otherwise unproductive House sessionresulted in passage of a bill for more oversight of “compounding pharmacies” — one of which was said to have caused 750 cases of fungal meningitis last fall and winter, including dozens in New Jersey. Some 64 people died nationwide.
The measure passed on a voice vote. But, it’s only a half a loaf. It would let compounding pharmacies register for voluntary regulation under the U.S. Food and Drug Administration.
These pharmacies are not your corner apothecary or national drugstore chain outlet. They make what is supposed to be customized, low-volume medication that the pharmaceutical giants won’t touch. Compounding pharmacies are necessary, but some are functioning just like the drug giants under full FDA regulation, manufacturing thousands of doses of certain items.
The sites are subject to spotty state licensing and inspection. It was just such a compounding pharmacy, the New England Compounding Center in Massachusetts, that Centers for Disease Control investigators say delivered steroid pain injections that were tainted with the dangerous and sometimes deadly fungus.
In South Jersey, the medicine was administered through sites such as Premier Orthopedic Associates in Vineland and South Jersey Healthcare’s Elmer and Vineland hospitals, now Inspira. Some 48 patients throughout New Jersey had tested positive for fungal meningitis as of January, state officials reported.
Large compounding pharmacies need more than a prod toward voluntary inspection. This watered-down bill now moves to the Senate. Lawmakers don’t want to over-regulate small compounders, but it shouldn’t be hard to separate them from these under-the-radar drug makers who can now get away with shipping thousands of doses made in filthy conditions.
If it walks like “big pharma,” it ought to be regulated like “big pharma.”
quoted from here

National Association of Board of Pharmacies October 2013 Newsletter Now Available--several compounding issues discussed

here