Updated Docket in Cincinnati Insurance Company V. Quorum Management Corp., Diamond State Insurance Company and Franck's Compounding Pharmacy- (Insurance Co.'s Lawsuit Against Franck's In Death of 21 Polo Horses)

U.S. District Court
Middle District of Florida (Ocala)
CIVIL DOCKET FOR CASE #: 5:12-cv-00406-WTH-PRL

The Cincinnati Insurance Company v. Quorum Management Corp. et al Assigned to: Senior Judge Wm. Terrell Hodges Referred to: Magistrate Judge Philip R. Lammens Cause: 28:2201 Declaratory Judgment (Insurance)

Date Filed: 07/19/2012 Jury Demand: Defendant Nature of Suit: 110 Insurance Jurisdiction: Diversity

Plaintiff
The Cincinnati Insurance Company	represented by	Chris Ballentine  Fisher, Rushmer, Werrenrath, Dickson, Talley & Dunlap, PA 390 N Orange Ave - Ste 2200 Orlando, FL 32801 407/843-2111 Fax: 407/422-1080 Email: cballentine@fisherlawfirm.com LEAD ATTORNEY ATTORNEY TO BE NOTICED David Arthur Glenny  Bice Cole Law Firm, PL Suite 101 1333 SE 25th Loop Ocala, FL 34471-1071 352/732-2255 Fax: 352-351-0166 Email: glenny@bicecolelaw.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
V.
Defendant
Quorum Management Corp. also known as Quorum Management Company	represented by	Alvaro L. Mejer  Mejer Law, PA Penthouse Suite 2222 Ponce de Leon Blvd Coral Gables, FL 33134 305/444-3355 Fax: 305-442-4300 Email: amejer@mejerlaw.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Juan Martin Nero	represented by	Craig B. Shapiro  Aran, Correa, Guarch & Shapiro, PA 255 University Dr Coral Gables, FL 33134 305/665-3400 Fax: 305/665-2250 Email: cshapiro@acg-law.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Guillermo Caset	represented by	Craig B. Shapiro  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Nicholas Espain	represented by	Craig B. Shapiro  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Anthony J. Campbell	represented by	Ashley B. Hacker  Ver Ploeg & Lumpkin, PA 30th Floor 100 SE 2nd St Miami, FL 33131-2158 305/577-3996 Fax: 305/577-3558 Email: ahacker@vpl-law.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  Ver Ploeg & Lumpkin, PA 30th Floor 100 SE 2nd St Miami, FL 33131-2158 305/577-3996 Fax: 305/577-3558 Email: cgudaitis@vpl-law.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  Ver Ploeg & Lumpkin, PA 30th Floor 100 SE 2nd St Miami, FL 33131-2158 305/577-3996 Fax: 305/577-3558 Email: rlumpkin@vpl-law.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Diamond State Insurance Company a/s/o Quorum Management Corp.	represented by	Joshua Ross Goodman  Cozen O'Connor Suite 4410 200 S Biscayne Blvd Miami, FL 33131 305/704-5940 Fax: 866/248-2897 Email: jgoodman@cozen.com LEAD ATTORNEY ATTORNEY TO BE NOTICED William E. Gericke  Cozen O'Connor The Atrium 1900 Market St Philadelphia, PA 19103 215/665-2146 Fax: 215/701-2146 Email: wgericke@cozen.com LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Defendant
Franck's Pharmacy, Inc. TERMINATED: 10/05/2012	represented by	Ashley B. Hacker  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Defendant
Franck's Lab, Inc.	represented by	Ashley B. Hacker  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Counter Claimant
Franck's Pharmacy, Inc. TERMINATED: 10/05/2012	represented by	Ashley B. Hacker  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Counter Claimant
Franck's Lab, Inc.	represented by	Ashley B. Hacker  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
V.
Counter Defendant
The Cincinnati Insurance Company	represented by	Chris Ballentine  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED David Arthur Glenny  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Counter Claimant
Anthony J. Campbell	represented by	Ashley B. Hacker  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Christine A. Gudaitis  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Richard Hugh Lumpkin  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
V.
Counter Defendant
The Cincinnati Insurance Company	represented by	Chris Ballentine  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED David Arthur Glenny  (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Date Filed	#	Docket Text
07/19/2012	1	COMPLAINT against All Defendants (Filing fee $ 350 receipt number OCA2558) filed by The Cincinnati Insurance Company. (Attachments: # 1 Exhibits A & B, # 2 Exhibit C Part 1, # 3Exhibit C Part 2, # 4 Exhibit D, # 5 Civil Cover Sheet)(MJT) (Entered: 07/20/2012)
07/24/2012		Summons issued as to Anthony J. Campbell, Diamond State Insurance Company, Franck's Lab, Inc., Franck's Pharmacy, Inc., Quorum Management Corp.. (MJT) (Entered: 07/24/2012)
07/25/2012	2	NOTICE of designation under Local Rule 3.05 - track 2. Signed by Deputy Clerk on 7/25/2012. (Attachments: # 1 consent forms) Copies mailed/emailed. (MAM) (Entered: 07/25/2012)
09/05/2012	3	RETURN of service executed on 08/16/12 by The Cincinnati Insurance Company as to Anthony J. Campbell. (Attachments: # 1 Exhibit A)(Glenny, David) Modified on 9/5/2012 (MJT). (Entered: 09/05/2012)
09/19/2012	4	NOTICE of Acceptance of Service of Process by Franck's Pharmacy, Inc.. (Gudaitis, Christine) Modified on 9/19/2012 (MJT). (Entered: 09/19/2012)
09/19/2012	5	NOTICE of Acceptance of Service of Process by Franck's Lab, Inc.. (Gudaitis, Christine) Modified on 9/19/2012 (MJT). (Entered: 09/19/2012)
09/20/2012	6	NOTICE of Appearance by Chris Ballentine on behalf of The Cincinnati Insurance Company (Ballentine, Chris) (Entered: 09/20/2012)
09/20/2012	7	ANSWER and affirmative defenses to 1 Complaint with Jury Demand, COUNTERCLAIM against The Cincinnati Insurance Company by Franck's Pharmacy, Inc., Franck's Lab, Inc..(Gudaitis, Christine) (Entered: 09/20/2012)
09/20/2012	8	CERTIFICATE of interested persons and corporate disclosure statement by Franck's Lab, Inc., Franck's Pharmacy, Inc. identifying Corporate Parent Franck's Lab, Inc. for Franck's Lab, Inc.; Corporate Parent Franck's Pharmacy, Inc. for Franck's Pharmacy, Inc... (Gudaitis, Christine) (Entered: 09/20/2012)
09/21/2012	9	NOTICE. (LMF) No PDF attached. Entered in error. Modified on 9/21/2012 (LMF). (Entered: 09/21/2012)
09/21/2012	10	NOTICE by Quorum Management Corp. of Acceptance of Service of Process (Mejer, Alvaro) (Entered: 09/21/2012)
09/21/2012	11	ANSWER and affirmative defenses to 1 Complaint by Quorum Management Corp..(Mejer, Alvaro) (Entered: 09/21/2012)
09/26/2012	12	CERTIFICATE of interested persons and corporate disclosure statement by The Cincinnati Insurance Company identifying Corporate Parent CINCINNATI FINANCIAL CORPORATION for The Cincinnati Insurance Company.. (Glenny, David) (Entered: 09/26/2012)
09/27/2012	13	ANSWER and affirmative defenses to 1 Complaint by Guillermo Caset, Nicholas Espain, Juan Martin Nero.(Shapiro, Craig) (Entered: 09/27/2012)
10/03/2012	14	ANSWER and affirmative defenses to 1 Complaint by Diamond State Insurance Company.(Goodman, Joshua) (Entered: 10/03/2012)
10/05/2012	15	AMENDED COMPLAINT for declaratory judgment and further relief filed by The Cincinnati Insurance Company. Related document: 1 Complaint filed by The Cincinnati Insurance Company.(Glenny, David) Modified on 10/9/2012 (LMF). (Entered: 10/05/2012)
10/15/2012	16	Agreed MOTION to stay Fee and Cost Claims Post-Judgment by Franck's Pharmacy, Inc.(Gudaitis, Christine) Modified on 10/16/2012 (LMF). (Entered: 10/15/2012)
10/22/2012	17	ORDER granting 16 Motion to stay fee and cost claims post-judgment for Defendant Franck's Lab, Inc.. Signed by Senior Judge Wm. Terrell Hodges on 10/22/2012. (LRH) (Entered: 10/22/2012)
10/22/2012	18	ANSWER and affirmative defenses with Jury Demand to 15 Amended complaint, Amended COUNTERCLAIM against The Cincinnati Insurance Company by Franck's Lab, Inc..(Gudaitis, Christine) (Entered: 10/22/2012)
10/24/2012	19	ANSWER and affirmative defenses to 15 Amended complaint by Quorum Management Corp..(Mejer, Alvaro) (Entered: 10/24/2012)
10/25/2012	20	Agreed MOTION to amend/correct 17 Order on motion to stay by Franck's Lab, Inc.. (Gudaitis, Christine) Modified on 10/26/2012 (MJT). (Entered: 10/25/2012)
10/25/2012	21	ANSWER and affirmative defenses to 15 Amended complaint by Guillermo Caset, Nicholas Espain, Juan Martin Nero.(Shapiro, Craig) Modified on 10/26/2012 (MJT). (Entered: 10/25/2012)
10/29/2012	22	ORDER granting 20 motion to amend/correct. See Order for details. Signed by Senior Judge Wm. Terrell Hodges on 10/29/2012. Copies mailed/emailed. (MAM) (Entered: 10/29/2012)
10/30/2012	23	REPLY to 18 Amended COUNTERCLAIM by The Cincinnati Insurance Company. Related document: 18 Answer to 15 Amended Complaint, Amended Counterclaim.(Glenny, David) Modified on 10/31/2012 (MJT). (Entered: 10/30/2012)
10/30/2012	24	Agreed MOTION for extension of time to file answer or otherwise plead re 15 Amended complaint by Anthony J. Campbell. (Gudaitis, Christine) Modified on 10/31/2012 (MJT). (Entered: 10/30/2012)
10/31/2012	25	ENDORSED ORDER granting 24 Defendant-Campbell's Agreed Motion for Extension of Time: on or before November 5, 2012, Defendant-Campbell shall file his response to Plaintiff's Amended Complaint. Signed by Magistrate Judge Philip R. Lammens on 10/31/2012. (JLS) (Entered: 10/31/2012)
10/31/2012		Set deadline for Anthony J. Campbell: Answer due by 11/5/2012. (MJT) (Entered: 10/31/2012)
11/05/2012	26	ANSWER and affirmative defenses to 15 AMENDED COMPLAINT , COUNTERCLAIM against The Cincinnati Insurance Company by Anthony J. Campbell.(Gudaitis, Christine) Modified on 11/6/2012 (MJT). (Entered: 11/05/2012)
11/14/2012	27	ANSWER and affirmative defenses to 15 AMENDED COMPLAINT by Diamond State Insurance Company.(Goodman, Joshua) Modified on 11/15/2012 (MJT). (Entered: 11/14/2012)
11/26/2012	28	REPLY to 26 Counterclaim by The Cincinnati Insurance Company. Related document: 26 ANSWER and affirmative defenses to 15 AMENDED COMPLAINT , COUNTERCLAIM filed by Anthony J. Campbell.(Glenny, David) Modified on 11/27/2012 (MJT). (Entered: 11/26/2012)
11/26/2012		***PRO HAC VICE FEES paid and Special Admission Attorney Certification Form filed by attorney William E. Gericke appearing on behalf of Diamond State Insurance Company (Filing fee $10 receipt number OCA3015.) (MJT) (Entered: 11/26/2012)
12/03/2012	29	CASE MANAGEMENT REPORT. (Glenny, David) (Entered: 12/03/2012)
12/05/2012	30	CASE MANAGEMENT AND SCHEDULING ORDER: Discovery due by 9/9/2013, Dispositive motions due by 10/8/2013, Pretrial Conference set for 12/18/2013 at 10:00 AM in Ocala Courtroom 3 A before Senior Judge Wm. Terrell Hodges, Jury Trial set for trial term commencing 1/6/2014 in Ocala Courtroom 3 A before Senior Judge Wm. Terrell Hodges. Signed by Deputy Clerk on 12/5/2012. Copies mailed/emailed. (MAM) (Entered: 12/05/2012)
12/07/2012	31	Unopposed MOTION for William E. Gericke to appear pro hac vice by Diamond State Insurance Company. (Attachments: # 1 Exhibit Affidavit of W. Gericke, # 2 Text of Proposed Order)(Goodman, Joshua) Motions referred to Magistrate Judge Philip R. Lammens. (Entered: 12/07/2012)
12/12/2012	32	ORDER granting 31 Defendant's Unopposed Motion for Admission Pro Hac Vice. See Order for details. Signed by Magistrate Judge Philip R. Lammens on 12/12/2012. (JLS) (Entered: 12/12/2012)
01/07/2013	33	NOTICE of Initial Disclosures by Quorum Management Corp. (Attachments: # 1 Exhibit "A" List of Documents)(Mejer, Alvaro) (***Counsel notified regarding Rule 26 Disclosures. Discovery Noticed mailed.***) Modified on 1/8/2013 (MJT). (Entered: 01/07/2013)

Too Many Franck's Compounding Lab, Franck's Lab Inc., Franck's Pharmacy, Inc. cases pending in Federal District Court to Post all the Dockets and Documents: Here is a List of Cases

1 Franck's Compounding Lab, Inc. (cr) flmbke 3:07-bk-03450 7 08/11/2007 04/14/2011 Standard Discharge 03/04/2009
2.    Not applicable
Civil Results
Party Name Court Case NOS Date Filed Date Closed

3 Franck's Compounding Lab (dft) flmdce 5:2010-cv-00147 890 04/16/2010 09/12/2011
4 Franck's Compounding Lab (dft) inndce 1:2012-cv-00197 365 06/19/2012
5 Franck's Compounding Lab (dft) inndce 1:2013-cv-00060 365 03/04/2013
6 Franck's Compounding Lab (dft) inndce 1:2013-cv-00061 362 03/04/2013
7 Franck's Compounding Lab (dft) laedce 2:2012-cv-02398 367 09/28/2012
8 Franck's Compounding Lab (dft) laedce 2:2012-cv-02608 367 10/26/2012
9 Franck's Compounding Lab (dft) laedce 2:2012-cv-02838 367 11/28/2012
10 Franck's Compounding Lab (dft) nvdce 3:2013-cv-00100 245 03/04/2013
11 Franck's Homecare, LLC (dft) flmdce 5:2012-cv-00603 110 10/26/2012
12 Franck's Infusion Pharmacy (dft) flmdce 5:2012-cv-00603 110 10/26/2012
13 Franck's Lab Inc (dft) inndce 1:2012-cv-00197 365 06/19/2012
14 Franck's Lab Inc (dft) inndce 1:2013-cv-00060 365 03/04/2013
15 Franck's Lab Inc (dft) inndce 1:2013-cv-00061 362 03/04/2013
16 Franck's Lab, Inc. (cc) flmdce 5:2012-cv-00406 110 07/19/2012
17 Franck's Lab, Inc. (cc) flmdce 5:2012-cv-00603 110 10/26/2012
18 Franck's Lab, Inc. (dft) flmdce 5:2010-cv-00147 890 04/16/2010 09/12/2011
19 Franck's Lab, Inc. (dft) flmdce 5:2012-cv-00406 110 07/19/2012
20 Franck's Lab, Inc. (dft) flmdce 5:2012-cv-00603 110 10/26/2012
21 Franck's Lab, Inc. (dft) laedce 2:2012-cv-02398 367 09/28/2012
22 Franck's Lab, Inc. (dft) laedce 2:2012-cv-02608 367 10/26/2012
23 Franck's Lab, Inc. (dft) laedce 2:2012-cv-02738 367 11/12/2012
24 Franck's Lab, Inc. (dft) laedce 2:2012-cv-02838 367 11/28/2012
25 Franck's Lab, Inc. (dft) nvdce 3:2013-cv-00100 245 03/04/2013
26 Franck's Management, L.L.C. (dft) laedce 2:2012-cv-02838 367 11/28/2012
27 Franck's Pharmacy Inc (dft) inndce 1:2013-cv-00060 365 03/04/2013
28 Franck's Pharmacy Inc (dft) inndce 1:2013-cv-00061 362 03/04/2013
29 Franck's Pharmacy Incorporated (am) txwdce 7:2004-cv-00130 890 09/27/2004 06/16/2011
30 Franck's Pharmacy, Inc. (cc) flmdce 5:2000-cv-00108 830 03/28/2000 09/11/2001
31 Franck's Pharmacy, Inc. (cc) flmdce 5:2012-cv-00406 110 07/19/2012
32 Franck's Pharmacy, Inc. (cc) flmdce 5:2012-cv-00603 110 10/26/2012
33 Franck's Pharmacy, Inc. (dft) flmdce 5:2000-cv-00108 830 03/28/2000 09/11/2001
34 Franck's Pharmacy, Inc. (dft) flmdce 5:2012-cv-00406 110 07/19/2012
35 Franck's Pharmacy, Inc. (dft) flmdce 5:2012-cv-00603 110 10/26/2012
36 Franck's Pharmacy, Inc. (dft) laedce 2:2012-cv-02398 367 09/28/2012
37 Franck's Pharmacy, Inc. (dft) laedce 2:2012-cv-02608 367 10/26/2012
38 Franck's Pharmacy, Inc. (dft) laedce 2:2012-cv-02738 367 11/12/2012
39 Franck's Pharmacy, Inc. (dft) laedce 2:2012-cv-02838 367 11/28/2012
40 Franck's Pharmacy, L.L.C. (dft) laedce 2:2012-cv-02838 367 11/28/2012
Appellate Results
Party Name Court Case NOS Date Filed Date Closed

41 Franck's Lab, Inc. (pty) 11cae 11-15350 1890 11/16/2011 10/18/2012

Colorado's Position As of December 18, 2012, as to Compounds Filled and Dispensed by Non-Resident Pharmacies

Colorado's Board of Pharmacy issued the following notice to non-resident pharmacies on December 18, 2012:

At its December 10, 2012 meeting, the Colorado State Board of Pharmacy ("Board") directed its staff to outreach to all of the nonresident pharmacies registered with the Board and explain that nonresident pharmacies may not distribute prescription drugs into Colorado. Colorado law only allows nonresident pharmacies to dispense aprescription for a patient and ship that finished prescription into Colorado. Nonresidentpharmacies may not distribute drugs, compounded or otherwise, into Colorado.If a pharmacy wishes to distribute drugs into Colorado, it must be registered as awholesaler in its state of residence and obtain a registration in Colorado as an Out-of-State Wholesaler. Additionally, if the pharmacy wishes to distribute compounded drugsinto Colorado, it must be registered with the Food and Drug Administration as amanufacturer.The Board has directed each nonresident pharmacy it registers to sign the attached affidavit to confirm the pharmacy is aware of Colorado law and will not distribute drugs into Colorado. Please ensure that this affidavit is signed and returned to the Board at the letterhead address or e-mailed to DORA_pharmacyboard@state.co.us no later than January 17,2013. 

To view the actual memo and a copy of the affidavit  Click here 

Meningitis outbreak: Tainted meds cost $6.50

aint Thomas Outpatient Neurosurgical Center paid a compounding pharmacy $6.50 a dose for the steroid medications blamed for making dozens of its patients sick and causing meningitis deaths, according to a new court filing.

An amended complaint filed Tuesday includes the clinic’s invoices from New England Compounding Center for 80 mg vials of preservative-free methylprednisolone acetate — a generic version of the brand-name drug Depo-Medrol. The court papers allege price was “the only motivation” for the pain clinic to make bulk purchases of the generic drug from the compounding pharmacy.

The clinic has yet to file an answer to the allegations made in the complaints, which give only one side of a legal dispute.

New England Compounding, which had a history of regulatory violations, shut down after inspections by the U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy documented multiple safety concerns, including dirty equipment.

Attorneys William Leader and George Nolan assert that other compounders charged more for the drug in the amended complaint they filed on behalf of Fred May and his wife, Loduska May of Murfreesboro. Fred May contracted fungal meningitis after undergoing multiple epidural steroid injections last summer — procedures that cost him as much as $1,000.

Drug prices can fluctuate due to supply and demand, but $6.50 per dose is less than some other pain clinics reported they were paying when the meningitis outbreak occurred. Dr. Tim Smyth, a Johnson City anesthesiologist, told The Tennessean last October that he typically paid between $15 and $20 for the compounded version of the drug, which was about half the rate of brand-name medication.

The amended complaint also added a new defendant, Saint Thomas Hospital — a half owner of the clinic. The original defendants in the case were the pain clinic and Howell Allen Clinic, the clinic’s other half owner.

The lawyers contend that the clinic is an agent of the hospital because they share a common name and the clinic is located on the hospital campus.

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Bill Introduced in Texas Allowing Out-of-State Inspections

83R10338 MAW-F
	By: Van de Putte	S.B. No. 1100

	A BILL TO BE ENTITLED
	AN ACT
	relating to the licensing and inspection of certain out-of-state
	pharmacies by the Texas State Board of Pharmacy; authorizing fees.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
	SECTION 1.  Subchapter B, Chapter 556, Occupations Code, is
	amended by adding Section 556.0551 to read as follows:
	Sec. 556.0551.  INSPECTION OF LICENSED OUT-OF-STATE
	PHARMACY. (a) The board may conduct a random inspection of a
	pharmacy that holds a Class E pharmacy license and that compounds
	sterile prescription drugs for delivery to patients in this state
	as necessary to ensure compliance with the safety standards and
	other requirements of this subtitle and board rules.
	(b)  The board by rule shall set fees in amounts reasonable
	and necessary to cover the costs incurred by the board in inspecting
	a pharmacy as provided by Subsection (a).
	SECTION 2.  Section 560.052, Occupations Code, is amended by
	amending Subsection (c) and adding Subsection (g) to read as
	follows:
	(c)  To qualify for a Class E pharmacy license, an applicant,
	in addition to satisfying the other requirements of this chapter,
	must provide to the board:
	(1)  evidence that the applicant holds a pharmacy
	license, registration, or permit in good standing issued by the
	state in which the pharmacy is located;
	(2)  the name of the owner and pharmacist-in-charge of
	the pharmacy for service of process;
	(3)  evidence of the applicant's ability to provide to
	the board a record of a prescription drug order dispensed by the
	applicant to a resident of this state not later than 72 hours after
	the time the board requests the record;
	(4)  an affidavit by the pharmacist-in-charge that
	states that the pharmacist has read and understands the laws and
	rules relating to a Class E pharmacy;
	(5)  proof of creditworthiness; and
	(6)  except as provided by Subsection (f) or (g), an
	inspection report issued:
	(A)  not more than two years before the date the
	license application is received; and
	(B)  by the pharmacy licensing board in the state
	of the pharmacy's physical location[, except as provided by
	Subsection (f)].
	(g)  A Class E pharmacy license may not be issued to a
	pharmacy that compounds sterile prescription drugs for delivery to
	patients in this state unless the pharmacy has been inspected by the
	board to ensure the pharmacy meets the safety standards and other
	requirements of this subtitle and board rules. The board by rule
	shall set fees in amounts reasonable and necessary to cover the
	costs incurred by the board in inspecting an applicant as required
	by this subsection.
	SECTION 3.  Not later than November 1, 2013, the Texas State
	Board of Pharmacy shall adopt rules as required by Section
	556.0551, Occupations Code, as added by this Act, and Section
	560.052, Occupations Code, as amended by this Act.
	SECTION 4.  Section 560.052, Occupations Code, as amended by
	this Act, applies only to an application for a pharmacy license
	submitted to the Texas State Board of Pharmacy on or after the
	effective date of this Act. An application submitted before the
	effective date of this Act is governed by the law in effect on the
	date the application was submitted, and the former law is continued
	in effect for that purpose.
	SECTION 5.  This Act takes effect September 1, 2013.

TN drug compounding bill loses safeguard Meningitis culprit broke the same rule this bill would erase

March 5, 2013

Six months after moldy medicine caused an outbreak of a deadly new form of meningitis, Congress does not have a single bill before it to improve regulation of compounding pharmacies, and the only legislation proposed in Tennessee would strip away an important safeguard.

The one proposal pending before the Tennessee General Assembly would eliminate the requirement that compounded drugs be prepared only with a patient-specific prescription.

New England Compounding Center, the maker of the moldy medicine, violated this requirement when it mass-produced and sold steroid drugs that were injected into people’s spines as a pain treatment, federal and state regulators have charged.

The sponsor of the state legislation, Sen. Ferrell Haile, R-Gallatin, is a pharmacist.

“Right now I cannot compound for more than one individual at a time,” Haile said. “That’s why we had all this stuff coming in from other states.”

The effort by Haile is in direct contrast to the situation in California, where the state pharmacy board and some legislators are working to eliminate an existing provision in California law that mirrors the provision in Haile’s bill.

Virginia Herold of the California Pharmacy Board said a pending bill would eliminate a so-called prescriber’s exemption allowing production of compounded drugs without patient-specific prescriptions under certain circumstances.

Traditionally, compounding was used by pharmacists to create a custom medication specifically for one patient.

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Colorado Rules That Became Effective January 2, 2013

to view these rules click here

A lot of Compounding Matters On March 21, 2013, Agenda for Colorado State Board of Pharmacy Including Complaints Filed

THE COLORADO STATE BOARD OF

PHARMACY

AGENDA

March2l,2013

CONVENE:

LOCATION: 1560 Broadway, Denver, CO 80202

Conference Room 110 D

Pursuant to statute, a portion of this meeting will be closed to the public.

Note: The agenda Is subject to change. If changes occur, a revised agenda will

be available at the meeting.

TIME: 8:30 a.m.

CONDUCTiNG: Paul Limberis, RPh

ROLL CALL:

Jeannine G. Dickerhofe, RPh Ginny P. Omdorff, MBA

Heather A. Hawker, JD Armand J. Potestio, RPh

Donald L. Johnson, RPh Luis Rivera-Lleras, RPh

Paul Limberis, RPh

APPROVAL OF THE MINUTES:

January 17, 2013

ADDITIONS

REPORTS

President’s Remarks

Program Director Wendy L. Anderson

 Task Force

House Bill 12-1059 MIlitary Spouse Exemption

Proposed Amendments to Board Policies 104 (Delegation of Authority to

Program Director or Section Director) and 20-3 (AdmInistrative Approval of

Licenses and Registrations). Proposed New Board Policy 20-14 (Designation of

Clearinghouse for License Transfer I Endorsement Applicants)

Proposed Amendments to Board Policies 30$ (UnregisteredlUnlicensed

Activity) & Board Policy 30-10 (Issuance of Licenses or Registration to

Facilities with Prior Cease and Desist Orders)

Proposed Remote Pharmacy Practice Policy & Procedure Manual Form

Standing Committee Reports

Colorado Pharmacist Society Liaison Chair: Paul Limberis, RPh

Governors Expert Emer9ency Member: Paul Limberis, RPh

Epidemic Response

Intern & School Relations Chair: Jeannine G. Dickerhofe, RPh

Legislation Chair: Jeannine G. Dickerhofe, RPh

2

Inspector’s Reports

Humane Society of Boulder County — Distribution of compounded veterinary

prescription drug and controlled substance from unlicensed entity

Colorado State Board of Pharmacy Laws and Rules Webinar March 12, 2013 Presented by the Inspectors

News

Colorado State Board of Pharmacy Laws & Rules Webinar

This is an opportunity for pharmacists to review the Colorado State Board of Pharmacy Laws and Rules. Special emphasis will be given to laws that went into effect on 7/1/12 and rules that went into effect on 1/1/13. The pharmaceutical inspectors will present the webinar. No C.E.U. will be available for this class. 

• Date: Tuesday, March 12, 2013
• Time: 9:00 - 11:00 a.m.

The following link can be used to register for this webinar. You will receive a confirmation email with further information.

Space is limited.
Reserve your Webinar Seat Now at:
https://www1.gotomeeting.com/register/992955240

System Requirements
PC-based attendees
Required: Windows® 7, Vista, XP or 2003 Server
Macintosh®-based attendees
Required: Mac OS® X 10.5 or newer
Mobile attendees
Required: iPhone®, iPad®, Android™ phone or Android tablet

Arizona State Board of Pharmacy Minutes for Compounding Task Force Meeting February 22, 2013; discuss 5% office use rule

Arizona State Board of Pharmacy
1616 W. Adams, Suite 120
Phoenix, AZ 85007
Telephone (602) 771-2727 Fax (602) 771-2749
THE ARIZONA STATE BOARD OF PHARMACY
HELD A COMPOUNDING TASK FORCE MEETING ON FEBRUARY 22, 2013
MINUTES FOR COMPOUNDING TASK FORCE MEETING
Call to Order – February 22, 2013
Chairman John Musil convened the meeting at 9:00 A.M. and welcomed the audience to the
meeting.
Roll Call and Introduction of Task Force Members
The following Task Force Members were present: Chairman John Musil, Tom Van Hassel, Rich
Monty, Eric Bauer, Dana Reed-Kane, Linda Carboni, Dennis Waggoner, Danielle Evans, and
Sandra Sutcliffe.
Dr. Musil stated that the Task Force had several items to review to see if the Task Force would
like to make recommendations for changes and/or additions to the Pharmacy Compounding
Rules. Dr. Musil stated that the Task Force could also recommended new proposed rules to the
Board.
Topics
1. Require PCAB accreditation
Dr. Musil opened the discussion by asking if the Task Force should require compounding
pharmacies to become PCAB accredited.
Ms. Reed- Kane stated that her pharmacy is PCAB accredited. She stated that it is a very
rigorous process. Ms. Reed-Kane stated that the accreditation is conducted by a private
organization and there is inspector bias. Ms. Reed-Kane stated that one inspector would tell
a pharmacy to do something one way and another inspector would tell a different pharmacy to
do the same thing a different way.
Ms. Reed-Kane stated that there should be a standardized accreditation process. Ms. Reed-Kane
stated that there are very confusing requirements for different processes.
State of Arizona 2 Compounding Task Force
Board of Pharmacy February 22, 2013
Ms. Reed-Kane stated that most of the accreditation process follows USP 797 and 795
requirements.
Mr. Van Hassel stated that maybe the task force should look at the different standards and
define the standards that need to be enforced instead of requiring accreditation by an outside
entity.
Mr. Bauer indicated that he has found that various inspectors view things differently.
Dr. Musil stated that PCAB had originally written the standards so that they were not
prescriptive. Dr. Musil stated that the standards were written so that the pharmacy determined
how the standards were met and did not state that the pharmacy had to do each process in a
specific fashion.
Dr. Musil stated that the task force could develop a list of standards that mirror the standards of
the accrediting bodies.
Mr. Waggoner stated that in manufacturing the FDA inspectors check to see if the manufacturer
is following the procedures that they have put in place according to the FDA regulations.
Separate licensure as compounders
Dr. Musil opened the discussion by asking if there should be a separate class for compounding
pharmacies.
Ms. Carboni stated that she believes that there are both patient and employee safety issues to
consider when compounding medications.
Mr. Van Hassel suggested that there could be a sterile compounding training program such as the
program required for giving immunizations.
Rules for Non – Resident Compounders
Mr. Van Hassel stated that California is planning to have different requirements for out of state
pharmacies.
Ms. Reed-Kane asked if there could be different guidelines for non-resident pharmacies.
Ms. Sutcliffe stated that the regulations do not allow for different guidelines.
Dr. Musil stated that maybe the Board could require that all products that come into Arizona
from non-resident permittees would be patient specific.
State of Arizona 3 Board Meeting
Board of Pharmacy February 22, 2013
Mr. Bauer stated that some products are being sent such as sterile products for home use from
non-resident pharmacies due to insurance requirements.
Ms. Reed-Kane stated that she has concerns about small facilities not having the appropriate
equipment to prepare certain medications.
Mr. Van Hassel stated that if the Board places too many restrictions on the compounding
pharmacies that it may encourage the doctor to compound the medications in their offices.
Ms. Evans stated that if the inspection reports are kept in the centralized database by NABP then
the Board would be able to look at the inspection reports for non-resident permittees.
Compounding during Drug Shortages
Dr. Musil stated that sometimes there are few options if a drug is needed. Dr. Musil noted that
some of the shortages are due to hoarding.
Ms. Carboni stated that when shortages occur at the hospital setting they are forced to require a
formulary change or restrict the use of the supply on hand.
Mr. Van Hassel stated that some of the current standards help create shortages because they are
forced to discard good product because of time frames for use.
The task force members discussed the outsourcing of compounding when the product is not
available.
Patient-Specific vs. Office Use
Dr. Musil opened the discussion by stating the only 5% of the total sales could be sent to
physician offices.
Mr. Van Hassel asked about the use of non- patient specific compounded products.
Ms. Evans stated that it is often difficult to make patient-specific products for veterinary use.
Dr. Musil stated that different types of compounding can be done at each site.
Mr. Bauer stated that due to USP 797 many hospitals did not want to stock all the products
that they may need and have outside pharmacies prepare the products for them.
Requiring Competencies that must be demonstrated before initiating compounding
Ms. Carboni stated that the task force would have to consider that pharmacies may compound
sterile products, non-sterile products, or both.
State of Arizona 4 Board Meeting
Board of Pharmacy February 22, 2013
Mr. Van Hassel stated that the Board must do what is best for the protection of the public. Mr.
Van Hassel noted that the job of the Board is not to protect the pharmacy or the manufacturer.
The task force members briefly discussed the requirement of having training programs in place
The task force members were reminded that items such as accreditation and additional licensure
would require a statutory change.
Call to the Public
Chairman Musil announced that interested parties have the opportunity at this time to address
issues of concern to the task force; however the task force may not discuss or resolve any issues
because the issues were not posted on the meeting agenda.
Rebecca Sheehan, a pharmacist, that works for a veterinary pharmacy came forth to address the
rule concerning the selling of 5% for office use. Ms. Sheehan stated that veterinary pharmacies
provide medications that are not available commercially and often the medications are made in
smaller doses for exotic animals. Ms. Sheehan stated that the veterinarian often needs to have
the medication on hand and 5% is hard to follow when the medication is used for multiple
animals.
The Task Force decided to hold their next meeting on March 21, 2013 from 2:00 P.M. to 4:00
P.M.
The meeting adjourned at 11:35.

Florida Department of Health Restricts Permit for Village Fertility; Florida Inspectors Receive Comprehensive Training

March 5, 2012

Contact: DOH Communications
(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH RESTRICTS PERMIT FOR VILLAGE FERTILITY
~Pharmacy restricted from shipping or dispensing in Florida~

TALLAHASSEE- On February 26, 2013 the Florida Department of Health executed a voluntary agreement to restrict practice with Village Fertility Pharmacy in Waltham, MA. The state of Massachusetts issued a Cease and Desist order and a notice of Quarantine against the pharmacy on February 20 after possible contamination of vials of progesterone, a hormone used to aid in fertility. Village Fertility is a sterile compounding pharmacy which also holds a non-resident pharmacy permit in Florida.

Black particulate matter was observed in 10 ml multi-use vials of the intramuscular progesterone oleate. Particulates have not been observed in other products manufactured by the company, however, the Massachusetts Board of Pharmacy has advised Village Fertility to recall all products based on the common production involved. Vials containing contaminant have been sent for testing to a Food and Drug Administration lab and after five days of culture there has been no growth of any biological material. Final results will be available March 7, 2013. There have been no reported adverse reactions to these products.

The notice issued by the state of Massachusetts requires Village Fertility to cease and desist all sterile compounding, quarantine all compounded sterile products on its premises and notify all patients who received certain vials. The voluntary agreement to restrict practice instructs Village Fertility Pharmacy to immediately cease compounding medications for Florida residents and to cease dispensing or shipping medications it has previously compounded to Florida residents.

There were 95 patients in Florida who received the recalled compounded products, leuprolide acetate and progesterone oleate. The Department of Health is proactively reaching out to recipients of these products to insure they were in fact notified by Village Fertility and that they are no longer in possession of any of the recalled products.

The Department remains vigilant to assure the safety of Florida’s drug supply. The Department’s inspectors receive comprehensive training in sterile compounding and carry out a prioritized inspection schedule based upon the results of a mandatory pharmacy compounding survey. That survey resulted in 55 complaints being opened and two emergency suspension orders being issued. The Florida Board of Pharmacy is also conducting a series of workshops to amend its rules governing the practice of compounding. The next workshop is scheduled for March 22, 2013 in Orlando.

Follow us on Twitter at @HealthyFla and on Facebook. For news story ideas, interviews, videos and more from DOH Communications visit the DOH Online Newsroom.

source found here

Opinion March 5, 2013 Senate in Oklahoma approved Safe Compounding Act The Norman Transcript

NORMAN — By a vote of 42-0, the full Senate has approved my proposal to ensure that out-of-state compounding pharmacies doing business in Oklahoma are held to high standards of safety.

The Safe Compounding Act will require out-of-state compounding pharmacies that deliver, dispense or distribute prescription drugs in Oklahoma to submit an affidavit and pharmacy site inspection form to receive a license.

I was compelled to author this bill after learning about a tragic story in Massachusetts where a compounding pharmacy was linked to hundreds of cases of fungal meningitis and 23 deaths. Just four of 37 similar specialty pharmacies were able to pass surprise health inspections shortly after the story broke.

Under this bill, the Oklahoma Board of Pharmacy will be able to oversee pharmacies in other states that may not operate by the same stringent standards that ours do. 

Source found here

Express Scripts report shows spending on traditional medicines fell in 2012 : Business

Express Scripts report shows spending on traditional medicines fell in 2012 : Business

Par Settles Off-Label Probe & Drops Free Speech Suit

By Ed Silverman // March 5th, 2013 // 11:40 am

Yet another drugmaker has settled charges of off-label marketing. The latest is Par Pharmaceuticals, which agreed to pay $22.5 million to resolve allegations that its Megace ES treatment for treating weight loss in AIDS patients was inappropriately marketed to seniors in nursing homes and hospices who did not suffer from the illness.

As part of the deal, Par agreed to plead guilty plea to a misdemeanor charge for introducing into interstate commerce a misbranded drug. Moreover, Par also dropped a lawsuit in which the drugmaker maintained its ability to convey “truthful” information to physicians is protected by the First Amendment, but was thwarted by FDA regulations governing off-label promotion (back story).

In convincing Par to drop its lawsuit, the FDA may have scored a victory, of sorts, in the heated debate over commercial free speech

Continue reading here