Meeting of South Carolina Senate Medical Affairs Subcommittee on H. 3161 Changes to Compounding Laws

Senate Medical Affairs Subcommittee

MEMORANDUM TO: Senator Ray Cleary, Subcommittee Chairman
Senator Brad Hutto
Senator Tom Davis
FROM: Senator Harvey Peeler
DATE: April 18, 2013
SUBJECT: Medical Affairs Subcommittee Meeting – H.3161, Reg. 4210 & Reg. 4296
A meeting of the Medical Affairs Subcommittee on H.3161, Reg. 4210 & Reg. 4296 is scheduled for Thursday, April 25, 2013 at 9:30 a.m. in room #407 Gressette Building. Please make every effort to attend. Thank You.
GENERAL BILL
H. 3161 -- Reps. Spires and Toole: A BILL TO AMEND SECTION 40-43-30, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO DEFINITIONS IN THE SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO DEFINE ADDITIONAL TERMS; TO AMEND SECTION 40-43-86, RELATING TO COMPOUNDING PHARMACIES, SO AS TO REVISE MINIMUM GOOD COMPOUNDING PRACTICES, TO PROVIDE A PHARMACIST MUST PERFORM A FINAL CHECK ON A PRODUCT COMPOUNDED BY A PHARMACY TECHNICIAN, TO MODIFY REQUIREMENTS FOR AN AREA USED FOR COMPOUNDING IN A PHARMACY, TO PROVIDE PHARMACISTS SHALL ENSURE CERTAIN EXPECTED FEATURES OF INGREDIENTS USED IN A FORMULATION, TO PROVIDE A MEANS FOR DETERMINING THE MAXIMUM BEYOND-USE DATE OF AN EXCESS AMOUNT OF A SPECIFIC COMPOUND IN CERTAIN CIRCUMSTANCES, TO REQUIRE CERTAIN WRITTEN POLICIES AND PROCEDURES APPLICABLE TO A COMPOUNDING AREA, AND TO PROVIDE THAT MATERIAL DATA SAFETY MUST BE READILY ACCESSIBLE TO PHARMACY PERSONNEL WHO WORK WITH DRUG SUBSTANCES OR BULK CHEMICALS, AND TO DELETE OBSOLETE LANGUAGE; AND TO AMEND SECTION 40-43-88, RELATING TO THE HANDLING OF STERILE PRODUCTS BY PHARMACIES, SO AS TO REVISE ASSOCIATED STANDARDS AND TO BROADEN THE APPLICATION OF THESE STANDARDS TO INCLUDE OTHER FACILITIES PERMITTED BY THE BOARD, AMONG OTHER THINGS.
REGULATIONSRegulation # 4210 Department of Health and Environmental Control
                                Licensed Midwives
Regulation # 4296 Department of Health and Environmental Control
                                Controlled Substances
Cc: Interested parties

Last Updated: Friday, April 19, 2013 at 11:18 A.M.

Large Shipments of Fake Drugs Seized by Federal Authorities From South Carolina Warehouse

March 20, 2013

Federal authorities seized $3.6 million-worth of counterfeit drug products from a warehouse in Columbia, SC. Fakes of medications such as Viagra^® and Cialis^® were shipped from India and stored in the warehouse for re-shipping, indicates the US Department of Homeland Security, Immigration and Customs Enforcement. South Carolina’s Secretary of State, whose office worked with federal agents during the investigation, told The State that he is happy the products are off the streets, and he stressed the health risks of using counterfeit medications.

South Carolina Proposed Legislation Relating to Pharmacy Practice Act and Compounding

VERSIONS OF THIS BILL
12/18/2012
2/20/2013

(Text matches printed bills. Document has been reformatted to meet World Wide Web specifications.) Indicates Matter Stricken
Indicates New Matter
COMMITTEE REPORT
February 20, 2013
H. 3161

Introduced by Reps. Spires and Toole S. Printed 2/20/13--H.
Read the first time January 8, 2013.

            
THE COMMITTEE ON MEDICAL,
MILITARY, PUBLIC AND MUNICIPAL AFFAIRS To whom was referred a Bill (H. 3161) to amend Section 40-43-30, Code of Laws of South Carolina, 1976, relating to definitions in the South Carolina Pharmacy Practice Act, so as to define additional terms, etc., respectfully

REPORT: That they have duly and carefully considered the same and recommend that the same do pass with amendment:
Amend the bill, as and if amended, by deleting all after the enacting words and inserting:
/ SECTION    1.    Section 40-43-30 of the 1976 Code is amended to read:
"Section 40-43-30.    For purposes of this chapter:
(1)    'Administer' means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.
(2)    'Ante area' means an ISO 8 or greater area where personnel perform hand hygiene, garbing, and stage components. An ante area precedes a buffer area, provided:
(a)    a buffer area must be separated by a wall from an ante area if high-risk preparations are compounded; and
(b)    if only low-risk and medium-risk preparations are compounded, separating an ante room from a buffer area is recommended.

South Carolina Board of Pharmacy Meeting Today, January 16, 2013: Agenda Contains Compounding Items

South Carolina Board of Pharmacy
Board Meeting - Revised Agenda (Revised 1/14/13)
9:00 a.m., January 16-17, 2013
110 Centerview Drive, Kingstree Building Room  108, Columbia, South Carolina
View Board  On-line at
Meeting Called to Order - This meeting is being  held in accordance with Section 30-4-80
of the S.C. Freedom of Information Act by notice mailed to The State newspaper, Associated
Press, WIS-TV and all other requesting persons, organizations, or news media.  In addition,
notice was posted on the bulletin boards at the two main entrances of the Kingstree Building.
Pledge of Allegiance
Introduction of Board Members and all other persons attending
Chairman's Remarks - Dan Bushardt, R.Ph.
1.   Approval of Minutes for November 15-16, 2012
2.   Approval of Reciprocity Candidates for Licensure: Nov. 5,  13, 16, 21, 26, 28, 29,
December 3,  6,10,11,13,17,19,20,21,27,2012; January 4,  8,2013.
3.   Administrator's Report - Lee Ann F. Bundrick, R.Ph.
4.   Reports from:
Office of Investigation and Enforcement
Office of General Counsel
Office of Information Services
Finance Report
5.   Compliance and Inspectors Report
IRC Recommendations for dismissals and dismissals with non-disciplinary letters of concern.
Review of proposed Relinquishments, Voluntary Surrenders from the Investigative Review
Committee (IRC).
•   Agreement to Relinquish
Case # 2012-91  Case # 2012-123
Case # 2012-112  Case # 2013-5
•   Consent Agreement
Case # 2012-32  Case # 2012-34  Case # 2012-84
Case # 2012-33  Case # 2012-58
•   Voluntary Surrender
Case # 2012-110  Case # 2012-120
Case # 2012-119  Case # 2012-126
•   Temporary Suspension
Case # 2012-124
6.   New Business
A.  Request Approval of Pharmacy Technician Registration applicationCaroline Alexander
B.  Request Release from Probation - Melinda Martland
C.   Request Reinstatement of Pharmacist License - Jennifer Boggs
D.   Request Approval of Pharmacist Reciprocity application - Karen Balcerzak
E.   Request Approval of Non-Resident Pharmacy permit application - Barney's
Pharmacy, Vanessa Looney, R.Ph.
F.   Request Approval of Pharmacy Technician Registration application­
Jessica Fullard
G.  Request Approval of Pharmacy Technician Registration application­
Kyle Heiser H.  Request Approval of Pharmacy Technician Registratio

K-V v. Keck: State of South Carolina's Motion in Opposition

To view South Carolina's Motion in Opposition, click here.
To view exhibit 1, click here.
To view exhibit 2, click here.
To view exhibit 3, click here.
To view exhibit 4, click here.
To view exhibit 5, click here.
To view exhibit 6, click here.

K-V v. Keck: State of South Carolina's Motion to Dismiss

To view the State of South Carolina's Motion to Dismiss, click here.

South Carolina Pharmaceutical Distribution Company Pleads Guilty in Multi-Million Dollar Scheme to Purchase and Sell Drugs in the Grey Market

Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE

Friday, August 10, 2012

South Carolina Pharmaceutical Distribution Company Pleads Guilty in Multi-Million Dollar Scheme to Purchase and Sell Drugs in the Grey Market

The Department of Justice announced the guilty plea and sentencing of Easley, S.C.-based Altec Medical for engaging in a multi-million dollar prescription drug scheme. Altec Medical pleaded guilty in U.S. District Court in Miami to one count of conspiring to defraud the U.S. Food and Drug Administration (FDA) and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.

In the sentencing, U.S. District Judge Robert N. Scola, Jr. ordered Altec to pay a $2 million fine and to forfeit $1 million. The judge also ordered the company to be on probation for one year.

In a criminal information filed with the court, the government charged that Altec paid its supplier and co-conspirator William D. Rodriguez, approximately $55 million for prescription drugs that it knew had been diverted from lawful channels of drug wholesale distribution. “Drug Diversion” refers to various ways in which prescription drugs are removed from lawful channels of distribution and then reintroduced into the marketplace for sale to consumers. In drug diversion schemes, prescription drugs at issue are often stolen from warehouses or cargo trucks; torn from boxes of free samples, repackaged and resold; or bought from individual patients looking to make extra money.

“Drug diversion undermines the safety and effectiveness of our prescription drug system,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “When individuals divert drugs from lawful channels, we cannot be sure that the drugs are properly handled and stored. As a result, diverted drugs could be expired, become contaminated, or have their mechanisms of action altered. Diversion is a serious crime that puts consumers at risk; we will continue to prosecute those who engage in it aggressively.”

The Justice Department advises consumers who have concerns about a drug to check the lot numbers on the manufacturer’s web site to see if there are any warnings about it.

According to a plea agreement that was filed with the court, Altec became aware that Rodriguez had bought these drugs from individuals who had acquired them illegally and who were not properly licensed to sell prescription drugs on a wholesale basis. The government further charged that Altec and Rodriguez orchestrated the reentry of these drugs into the lawful channels of distribution. According to the government, Rodriguez first sent the diverted drugs to companies he controlled in South Carolina. His companies, in turn, resold the drugs to Altec, which, in turn, resold the drugs to various purchasers throughout the United States, including drug distributors with valid drug distribution licenses. This process caused reentry of the diverted drugs into the ordinary, lawful channels of distribution. Eventually, the diverted drugs were bought by retail pharmacies, which dispensed the drugs by filling prescriptions for individual consumers.

Finally, the government charged that Altec and Rodriguez attempted to conceal their scheme by falsifying a variety of business records. In particular, Altec and Rodriguez falsified documents known as “drug pedigrees.” Drug pedigrees are statements required by the FDA of all those who sell wholesale quantities of prescription drugs. The drug pedigrees are supposed to accurately identify all prior sales and transactions so that it is clear that the drugs have been acquired lawfully, and properly stored and held along the way. Despite knowing that the law required accurate pedigrees, Altec admitted that it created pedigrees that falsified prior transactions to make it appear as though the drugs had originally been acquired lawfully.

Use of diverted drugs can cause unpredictable adverse side effects and may fail to treat the condition for which a consumer is taking the drugs. According to the government, neither purchasers who bought from Altec nor consumers who later bought the drugs at retail pharmacies would have purchased the drugs had they known that the drugs had been diverted.

In June 2012, in U.S. District Court in Miami, Rodriguez pleaded guilty to conspiracy and money laundering in a separate case charging him with, among other things, his role in this drug diversion scheme. He has not yet been sentenced.

The case was prosecuted by Assistant U.S. Attorney Jon M. Juenger, of the U.S. Attorney’s Office for the Southern District of Florida, and David A. Frank, of the Justice Department’s Consumer Protection Branch. Additional assistance was provided by Joshua Eizen, of the FDA’s Office of Chief Counsel for Enforcement. The case was investigated by the FDA’s Office of Criminal Investigations.

Source can be found here.

K-V Complaint Against State of South Carolina

Click here to view complaint.

K-V v. Keck-State of South Carolina Docket: List of Dockets Filed So Far

K-V Pharmaceutical Company et al v. Keck, Assigned to: Chief Judge Margaret B Seymour
Cause: 42:1396 - Tort Negligence

Note you cannot click on any of the links and view the documents without setting up a Pacer account and paying for the documents. As I have time, I will post some of the main documents on the blog. 

Date Filed	#	Docket Text
07/25/2012	1	COMPLAINT against Anthony Keck ( Filing fee $ 350 receipt number 0420-4206208.), filed by Ther-Rx Corporation, K-V Pharmaceutical Company. (Attachments: # 1 Exhibit Index, # 2Exhibit 1 - FDA Questions and Answers, # 3 Exhibit 2 - FDA Statement on Makena, # 4 Exhibit 3 - FY2012 FDA Budget Request, # 5 Exhibit 4 - FDA Statement on Makena, # 6 Exhibit 5 - FDA Updated Statement on Compounded Versions, # 7 Exhibit 6 - CMS, # 8 Exhibit 7 - SCDHHS Medicaid Bulletin, # 9 Exhibit 8 - email from Anthony Keck to Joseph Auci, # 10 Exhibit 9 - Magellan Medicaid Administration)(mdea ) (Entered: 07/26/2012)
07/25/2012	4	Local Rule 26.01 Answers to Interrogatories by K-V Pharmaceutical Company, Ther-Rx Corporation.(mdea ) (Entered: 07/26/2012)
07/25/2012	5	Summons Issued as to Anthony Keck. (mdea ) (Entered: 07/26/2012)
07/26/2012	6	MOTION for Preliminary Injunction by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. (Attachments: # 1 Memo in Support Plaintiff's Memorandum in Support of Motion for Preliminary Injunction, # 2 Exhibit A - Declaration of Michael Jozwiakowski, # 3 Exhibit List to Declaration of Michael Jozwiakowski (Exhibit A), # 4Exhibit A-1 - March of Dimes, Prematurity Campaign, The Economic and Societal Costs, # 5 Exhibit A-2 - March of Dimes, Neonatal Death, # 6 Exhibit A-3 - March of Dimes, Born Too Soon, # 7 Exhibit A-4 - Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States, # 8 Exhibit A-5 - Letter from John McCormick to Catherine Williams, # 9Exhibit A-6 - Letter from Julie Beitz to Robb Hesley, # 10 Exhibit A-7 - U.S. Food & Drug Administration, Review by the Division of Reproductive & Urologic Products, # 11 Exhibit A-8 - Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate, # 12 Exhibit A-9 - Letter from Paul Meis to Whom it May Concern, # 13 Exhibit A-10 - Follow-up of Children Exposed to Utero to 17 [alpha]-hydroxyprogesterone Caproate Compared with Placebo, # 14 Exhibit A-11 - Use of Progesterone to Reduce Preterm Birth, Nov. 2003, # 15 Exhibit A-12 - Use of Progesterone to Reduce Preterm Birth, Oct. 2008, # 16 Exhibit A-13 - Compounding Problems and Compounding Confusion, Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, # 17 Exhibit A-14 - Report, Limited FDA Survey of Compounded Drug Products, # 18 Exhibit A-15 - 2006 Limited FDA Survey of Compounded Drug Products, #19 Exhibit A-16 - Compounded Drug Testing Report (2009), # 20 Exhibit A-17 - Investigation of Product Quality Between Extemporaneously Compounded Progesterone Vaginal Suppositories and a Approved Progresterone Vaginal Gel, # 21 Exhibit A-18 - Pathway to Global Product Safety and Quality, # 22 Exhibit A-19 - Media Briefing on Heparin (2008), # 23 Exhibit A-20 - Melanine Contamination in China (2009), # 24 Exhibit A-21 - Drug Safety, FDA Has Conducted More Foreign Inspections and Begun to Improve its Information on Foreign Establishments, but More Progess is Needed (2010), # 25 Exhibit A-22 - Testimony of Randall W. Lutter, Ph.D. (Mar. 7, 2007), # 26 Exhibit A-23 - U.S. Food and Drug Administration, FDA Statement on Makena (Nov. 8, 2011), # 27 Exhibit A-24 - Press Release, KV Pharmaceutical Company, Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena and Compounded 17P Formations, # 28 Exhibit A-25 - FDA, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 29 Exhibit A-26 - Centers for Medicare and Medicaid Services, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 30 Exhibit A-27 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena))Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) Modified on 7/26/2012 to edit text (mdea, ). Modified on 7/26/2012 to reflect additional attachments filed as entries 7 , 8 and 9 (mdea, ). (Entered: 07/26/2012)
07/26/2012	7	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Thomas McHugh (Exhibit B). (Attachments: # 1 Exhibit List to Declaration of Thomas McHugh (Exhibit B), # 2 Exhibit B-1 - 2003 NIH Study re Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate, # 3 Exhibit B-2 - 2007 NIH Study re Follow-up of Children Exposed in Utero to 17 alpha-hydroxyprogesterone Caproate Compared with Placebo, # 4 Exhibit B-3 - Agreement between the NICHD Maternal-Fetal Medicine Units Network and Adeza Biomedical Corporation regarding 17-hydroxyprogesterone caproate, # 5 Exhibit B-4 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., re Accelerated Approval for NDA 021945, # 6 Exhibit B-5 - Feb. 10, 2011 Letter from R. Hesley, Hologic, to S. Monroe, FDA, # 7 Exhibit B-6 - KV Form 8-K (March 8, 2011), # 8 Exhibit B-7 - March 30, 2011 FDA Statement, # 9 Exhibit B-8 - March 30, 2011 CMS Statement, # 10 Exhibit B-9 - Medicaid Bulletin issued by the SCDHHS, # 11 Exhibit B-10 - SCDHHSs July 3, 2012 interpretation of its policy, # 12 Exhibit B-11 - Magellan Medicaid Administration Drug Lookup, # 13 Exhibit B-12 - CMS June 15, 2012 Informational Bulletin, # 14Exhibit B-13 - FDAs June 15, 2012 Press Release, # 15 Exhibit B-14 - FDAs June 29, 2012 Question and Answer document, # 16 Exhibit B-15 - KV Form 10-K for the year ending March 31, 2012 (relevant pages))(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	8	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Scott Goedeke (Exhibit C). (Attachments: # 1 Exhibit List to Declaration of Scott Goedeke (Exhibit C), # 2 Exhibit C-1 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., # 3 Exhibit C-2 - Ther-Rxs Medicaid Drug Rebate Agreement, # 4 Exhibit C-3 - US FDA, Review by the Division of Reproductive & Urologic Products, NDA 21-945, 17a-Alpha Hydroxyprogesterone Caproate at 9 (Aug. 2, 2006), # 5 Exhibit C-4 - Zsakeba T. Henderson, et al., Attitudes and Practices Regarding Use of Progesterone to Prevent Preterm Births, Am. J. Perinatology 529, 532 (2009), # 6 Exhibit C-5 - Joanna E. Adamczak, et al., What prevents eligible patients from receiving 17-alpha-hydroxyprogesterone caproate therapy, Am. J. of Obstetrics & Gynecology (Jan. 2011), # 7 Exhibit C-6 -March C-6 - March 2011 testimony of FDA Commissioner Margaret Hamburg1 testimony of FDA Commissioner Margaret Hamburgny, # 8 Exhibit C-7 - FDAs Nov. 8, 2011 Press Release, # 9 Exhibit C-8 - FDAs June 15, 2012 Press Release, # 10 Exhibit C-9 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 11 Exhibit C-10 - CMS Release No. 155, # 12 Exhibit C-11 - CMS Release No. 158, # 13 Exhibit C-12 - CMS June 15, 2012 Press Release, # 14 Exhibit C-13 - Feb. 20, 2012 KV Letter to Mr. Keck, # 15 Exhibit C-14 - March 22, 2012 Keck Letter to KV, # 16 Exhibit C-15 - July 3, 2012 email exchange between Mr. Auci and Mr. Keck, # 17 Exhibit C-16 - Correspondence to SCDHHS by Providers in SC who would like to prescribe Makena to their Medicaid patients)(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	9	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Dr. Lawrence Robillard (Exhibit D). (Willis, Marguerite) (Entered: 07/26/2012)
07/27/2012	10	SUMMONS Returned Executed by Ther-Rx Corporation, K-V Pharmaceutical Company. Anthony Keck served on 7/26/2012, answer due 8/16/2012. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	11	AFFIDAVIT of Service for Motion for Preliminary Injunction, Memorandum in Support of Motion for Preliminary Injunction served on Byron Roberts on 07/27/2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Byron Roberts)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	12	MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) additional attachment entry 15 added on 7/30/2012 (asni, ). addtional attachment entry 19 added on 8/2/2012 (asni, ). (Entered: 07/27/2012)
07/27/2012	13	MOTION to Appear Pro Hac Vice by Drew William Marrocco ( Filing fee $ 250 receipt number 0420-4210820) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) (Entered: 07/27/2012)
07/30/2012	15	Additional Attachments to Main Document 12 MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) Certificate of Good Standing. (Willis, Marguerite) (Entered: 07/30/2012)
07/30/2012	16	AFFIDAVIT of Service for Motion for Preliminary Injunction, and Plaintiffs' Memorandum in Support of Motion for Preliminary Injunction served on Brenda James on behalf of Anthony Keck on July 26, 2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/30/2012)
07/31/2012	17	TEXT ORDER granting 13 Motion to Appear Pro Hac Vice Signed by Chief Judge Margaret B Seymour on 7/31/2012.(asni, ) (Entered: 07/31/2012)
08/01/2012	18	NOTICE of Hearing on Motion 6 MOTION for Preliminary Injunction : Motion Hearing set for 8/28/2012 03:00 PM in Columbia # 3, Matthew J. Perry Court House, 901 Richland St, Columbia before Chief Judge Margaret B Seymour. Plaintiff is responsible for notifying defendant of hearing.(mdea ) (Entered: 08/01/2012)
08/02/2012	19	Additional Attachments to Main Document 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall. (Willis, Marguerite) (Entered: 08/02/2012)
08/02/2012	20	TEXT ORDER granting 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall Signed by Chief Judge Margaret B Seymour on 8/2/2012.(asni, ) (Entered: 08/02/2012)

SC to fight lawsuit over pre-term birth drug

By: Robert Kittle | WSPA-TV
Published: August 01, 2012 Updated: August 01, 2012 - 10:12 PM

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COLUMBIA, SC -- South Carolina's Department of Health and Human Services is vowing to fight a lawsuit filed against it by a pharmaceutical company. K-V Pharmaceutical has also filed separate lawsuits against Georgia and the U.S. Food and Drug Administration.
Regardless of the outcome it will cost state taxpayers money, either in the cost of defending the lawsuit or in added Medicaid costs. A spokesman for DHHS says the agency doesn't have an estimate for how much the lawsuit may cost.
The lawsuit is about a drug given to pregnant women to prevent pre-term births. Since 2005, South Carolina has been using a generic version of the drug known as 17P. It's actually a hormone, hydroxyprogesterone caproate.
According to DHHS, "The use of compounded 17P is accepted by doctors as a safe and effective therapy to fight prematurity, and since 2005 SCDHHS has worked closely with physicians statewide to make it readily available to women at risk of pre-term births. SCDHHS, the March of Dimes, the SC Chapter of the American College of Obstetrics and Gynecology and the South Carolina Hospital Association are working together through the statewide Birth Outcomes Initiative to actively promote the use of 17P."
But K-V Pharmaceutical is suing, arguing that South Carolina and Georgia should be using only its version of the drug, named Makena. In a release, the company says, "In certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations."

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Website with Links to All the State Laws Relating to Compounding

The Compounding Pharmacy Compliance website contains links to all the state laws relating to compounding.  Click here to view the links. This website also contains other useful information.  For example, this website points out that Texas and South Carolina allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. The specific requirements that must be found in these contracts can be found in each state's rules.