Sunday, June 30, 2013
The Law of Compounding Medications And Drugs: Compounders Still Disappointed at Latest Senate Ve...
The Law of Compounding Medications And Drugs: Compounders Still Disappointed at Latest Senate Ve...: Senate Health Committee Updates Compounding Bill, But Concerns Persist Drug compounders -- expressing disappointment in the latest vers...
Compounders Still Disappointed at Latest Senate Version of Compounding Bill
Senate Health Committee Updates Compounding Bill, But Concerns Persist
Drug compounders -- expressing disappointment in the latest version of the Senate compounding bill -- said the legislation further bolsters FDA's authority and favors the drug industry.
source found here
Push Back on Harvard Pilgrim Compounding Policy Change
(Daily News - 06-25-2013)
A New England insurer's new policy restricting coverage for compounded medications has not been replicated by other companies regionally and nationwide, sources said, as Harvard Pilgrim faces pushback over the change.
quoted from here
IACP Comments on House Draft ComIpounding Bill
Last week, IACP was asked to submit comments on a House draft bill being put forth by U.S. Representative Morgan Griffith (R-VA). Please click here to read IACP's comments.
IACP's Latest (June 27, 2013) Summary on the Senate HELP Committee Version of the Compounding Bill--and Copy of Latest Draft
Senate Releases Revised Compounding Bill, Today
The Senate has just released its revised version of the Compounding Bill. Please click here to review. The IACP Legislative Team currently is reviewing this Bill line-by-line, and will provide a comprehensive report as soon as completed. Please see IACP's initial comments below:
Initial Summary
The language in S. 959 released on Thursday, 27 June 2013 includes the following:
The language in S. 959 released on Thursday, 27 June 2013 includes the following:
- A definition that all compounded drugs are "new drugs" as defined within the FDCA (page 57)
- Defines the repackaging and distribution in interstate commerce of sterile drugs without individual patient prescriptions as the activities of a "compounding manufacturer." (page 59)
- Provides for anticipatory compounding only in instances where the historical volume is directly associated with an individual patient prescription (page 64)
- Hospitals and health-systems with wholly owned inpatient and outpatient facilities are exempted from being considered compounding manufacturers even if they ship interstate (page 66)
- Traditional compounding is exempted from the "new drug" requirements of an NDA/ANDA and the AERS if the pharmacy is in full compliance with this section of the law as well as state law. (page 66)
- The FDA may develop a "do not compound" list based upon "demonstrably difficult" criteria (which is undefined). (pages 68/69)
- The FDA may develop a "do not compound" list for drugs which are currently under a REMS when produced by manufacturers (page 69)
- Compounding of "commercially available" products are restricted to "documented clinical differences" for an individual identified patient or, if in drug shortage, subject to a 3 day notification to the FDA requirement (page 72-74)
- Compounding manufacturers who are preparing drugs that are in shortage must notify the FDA 14 days in advance before preparing any compounds. (page 73)
- The repackaging of a currently marketed drug into a format/dosage form that is also currently marketed (e.g., Avastin and Lucentis) is prohibited. (page 74)
- Prior to compounding a medication under REMS may only be done so with prior advance proof and submission to the FDA that the pharmacy is capable of meeting the REMS requirements (page 77)
- API-based compounding must still be upon the existence of a monograph or when using a drug product that appears on a list to be established by the FDA. No mention is made of other nationally recognized compendia (e.g., homeopathic medicines). (Page 77)
- The FDA is empowered to prohibit the compounding of a preparation with an API-based ingredient even if there is a monograph published in the FDA (Page 80)
- The GAO will prepare an analysis and report on veterinary compounding. (page 106)
- False and misleading advertisements of a compounded preparation by either a traditional compounder or manufacturer has defined penalties (107)
References to compliance with USP standards that appeared in an earlier draft have been removed. No language provided by IACP to preserve the ability of prescribers to order "office-use" medications was included.
quoted from here
IACP P2PC Offering Free Postcard Download to Members to Send to Patients-wants to increase advocacy group from 164,000 to 200,000 this year
IACP P2PC Has the following downloads available:
Pharmacy Compounding - General
Compounding for Bio-identical Hormone Patients
Compounding for Veterinary Patients
Compounding for Pediatric Patients
Compounding for Geriatric Patients
Go to IACP website to download
TN pharmacy board sets July meeting Jun. 29, 2013 |
he Tennessee Board of Pharmacy will take disciplinary actions and consider requests for reinstatement of licenses when it meets July 9 and 10.
The meeting occurs as new rules are coming into effect allowing the state to take quicker action against a compounder’s license when a serious safety issue arises. The board has had to deal with two outbreaks in the past year stemming from contaminated medicines made by compounding labs.
July’s meeting begins at 9 a.m. July 9 in the Iris Room at 227 French Landing. The second day begins at 8 a.m. July 10 at the same location.
Other new rules recently instituted by the board create a separate licensing category for medicine manufacturers, require proof that a manufacturer is registered with the U.S. Food and Drug Administration and require special registration whenever any pharmacy — whether retailer, manufacturer or wholesaler — performs sterile compounding.
The board began looking at its rules following the fungal meningitis outbreak that began last summer. A more recent outbreak underscored the need for better regulations.
While the fungal meningitis outbreak, which was first discovered in Tennessee, was traced to a steroid made by Massachusetts-based New England Compounding Center, another outbreak of what have thus far been less serious illnesses involving the same medicine has been linked to a Tennessee-based operation, Main Street Family Pharmacy in Newbern.
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
quoted from here
Medication shortages: 'Truly a public health crisis'
Marie McCullough, Inquirer Staff Writer POSTED: Sunday, June 30, 2013, 6:32 AM Rationing medical care is denounced as immoral in the United States, yet it goes on daily in hospitals, clinics, nursing homes, ambulances, and pharmacies. Since 2006, this country has had worsening shortages of sterile generic injectables - drugs given by shots or intravenously. Currently, more than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supply.
Read more at http://www.philly.com/philly/health/20130630_Medication_shortages___Truly_a_public_health_crisis_.html#idTHsRwivo5euUCv.99
Friday, June 28, 2013
SCOTUS Bartlett Decision Highlights Instability Of Federal Pre-emption Law
The Supreme Court's decision Monday (June 24) that federal law pre-empts state law in the case of a generic design defect claim highlights the instability of this area of the law and could prompt Congress to re-examine the issue, attorneys said.
quoted from here
United States Senate HELP Committee Updates Compounding Bill--Compounders Still Not Happy
Senate Health Committee Updates Compounding Bill, But Concerns Persist
Drug compounders -- expressing disappointment in the latest version of the Senate compounding bill -- said the legislation further bolsters FDA's authority and favors the drug industry.
source found here
NCPDP WG10 Specialty and Compound Pharmacy Task Group
| NCPDP WG10 Specialty and Compound Pharmacy Task Group 7/1/2013 - 7/1/2013
10:30am Pacific, 11:30 am Mountain, 12:30 pm Central, 1:30 pm Eastern
more information here
|
Tricare to stop covering some compounded prescription drugs-changed effects 44000 Tricare beneficiaries; Tricare received roughly 500,000 compound claims from beneficiaries in 2012, worth $330 million.
Starting July 24, Tricare will no longer cover compounded prescriptions drugs that contain ingredients not approved by the Food and Drug Administration.
Tricare pharmacy benefit manager Express Scripts sent letters this month to 44,000 Tricare affected beneficiaries notifying them of the change.
The beneficiaries will have to speak with their doctors about alternatives, or to their pharmacist to determine whether their formula can be altered to comply with the new requirement.
Compounded medications are tailored for individuals by pharmacists, combining a conventional medication with other ingredients to tweak a dosage, change delivery (from a pill to a liquid or liquid to a patch, for example) or eliminate an allergen.
Many compounded prescriptions use inert ingredients such as bulk chemicals and powders that are not subject to FDA approval, and by law, Tricare is barred from providing prescription drug coverage for compounds with unapproved ingredients, Tricare spokesman Austin Camacho said.
The move also protects the beneficiary, he added: “Most bulk chemicals and bulk powders are not subjected to FDA approval, therefore their safety and effectiveness is not established.”
Tricare decided to stop reimbursing claims for these medications because recent changes to federal standards for pharmacy claim submissions have led to an increase in oversight of all pharmacy claims, including those in government and commercial plans.
The new standards “have increased the visibility of what is contained in a compounded prescription” and Tricare now has the ability to identify compound prescription claims that contain a non-approved ingredient, Camacho said.
Tricare received roughly 500,000 compound claims from beneficiaries in 2012, worth $330 million.
Camacho stressed that Tricare is not halting all reimbursements for compounded prescriptions, just those with unapproved ingredients or not subject to FDA approval, such as vitamins and dietary supplements.
“This is a vital service that helps many people, including those who need medications that are not available commercially and others who are allergic to inactive ingredients in FDA-approved medicines,” Camacho said.
quoted from here
Compounding Animal Drugs from Bulk Ingredients: Not Prohibited by Federal Food Drug and Cosmetic Act, Affirmed as Recently as 2011 June 28, 2013 - See more at: http://www.mcguirewoods.com/Client-Resources/Alerts/2013/6/Compounding-Animal-Drugs-Bulk-Ingredients.aspx#sthash.ztsQGwz4.dpuf
Compounding Animal Drugs from Bulk Ingredients: Not Prohibited by Federal Food Drug and Cosmetic Act, Affirmed as Recently as 2011
June 28, 2013
The Federal Food Drug & Cosmetic Act (FD&CA) gives FDA broad, wide and far-reaching regulatory powers. Prohibiting the compounding of medicines from bulk ingredients, however, is not one of them. The position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients is simply incorrect.
A federal district court, the only court to review the issue, explicitly rejected the position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients:
The undisputed evidence … shows that allowing the FDA to enjoin a pharmacist’s traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without necessary medication. Such a result would be especially troublesome because the FDA’s longstanding policy has been to permit, and even promote, pharmacists’ compounding from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without explanation, especially where it asserted expansion of authority impacts the federal-state balance and potentially subjects many individuals and companies to criminal liability.
United States v. Franck’s Lab, Inc., et al. (816 F. Supp. 2d 1209 (M.D. Fl. 2011) (emphasis added)).
The FDA’s Historical Regulation and Enforcement of Compounding with Bulk Substances Further Questions the Implied FD&CA Prohibition
| 1938 | For approximately the first 50 years after the enactment of the FD&CA in 1938, the FDA generally left regulation of compounding to the states. |
| 1988 | United States v. 9/1 Kg. Containers (854 F.2d 173 (7th Cir. 1988)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished 9/1 Kg. Containers as being inapplicable to pharmacists. |
| 1989 | United States v. Algon Chemical, Inc., (879 F.2d 1154 (3rd Cir. 1989)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished Algon Chemical, Inc. as being inapplicable to pharmacists. |
| 1992 | The 1992 Compliance Policy Guide listed nine noninclusive activities that the FDA believed improperly crossed the line between “pharmacist” and “manufacturer.” Compounding drugs from bulk substances was not among the nine prohibited practices. |
| 1994 | Animal Medicinal Drug Use Clarification Act (AMDUCA) – The FDA regulations promulgated to implement AMDUCA. The regulations did not purport to regulate the practice of compounding and instead point to the FDA’s nonbinding guidance documents regarding compounding. Further, the regulations distinguish between nonfood-producing animals and food-producing animals. With regard to nonfood-producing animals, the regulations state: “[b]ecause extralabel use of animal and human drugs in nonfood-producing animals … does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened.” |
| 1996 | The 1996 Compliance Policy Guide listed 13 situations that would likely indicate compounding subject to regulatory action. Compounding from bulk drug substances for use in nonfood animals was expressly identified as a “compounding situation [which] would not ordinarily be considered a regulatory action.” Compounding from bulk drugs for use in food animals, however, was one of the listed scenarios. The FDA noted in the Guide that there was “occasionally a need to utilize … bulk drug substances for compounding into an appropriate dosage form.” The FDA would thus condone compounding animal drugs from bulk where (1) a legitimate medical need was identified; (2) there was “a need for an appropriate dosage regimen” for the patient’s species; and (3) there was “no marketed approved animal drug” that “may treat the condition diagnosed in the available dosage form.” The FDA asserted in the Guide that “two Federal Appeals Court decisions, Algon and 9/1 kg. Containers, affirmed the FDA position that the FD&CA does not permit veterinarians to compound unapproved finished drug products from bulk drugs unless the finished drug is not a new animal drug. The principle established by the court applies equally to compounding by pharmacists.” Notably, the FDA similarly asserted in the Guide that compounding a new animal drug from “an approved … human or animal drug” would result in a violation of the FD&CA, but acknowledged that this would no longer be the case when the AMDUCA became effective. |
| 1997 | The Food and Drug Modernization Act of 1997 (FDAMA) authorized pharmacists to compound drug products “using bulk drug substances” so long as the bulk drugs comply with the applicable USP monograph or if no monograph exists, the bulk drugs are components of drugs approved by the FDA. |
| 2000 | In FDA v. Brown & Williamson (529 U.S. 120 (2000)), the Supreme Court found that in certain circumstances, a literal reading of a broadly drawn public health statute (specifically, the FD&CA) should be rejected when it encompasses conduct that exceeds the original congressional intent. The Court declared that “Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion” and the Court found that the FDA’s claim to jurisdiction contravened the clear intent of Congress. |
| 2002 | In Thompson v. Western States (535 U.S. 357 (2002)), the Supreme Court noted the importance of compounding and agreed with the government’s position that because obtaining FDA approval for a new drug is a costly process, it would as a practical matter “eliminate the practice of compounding and thereby eliminate availability of compounded drugs for those patients who have no alternative treatment.” Although the Supreme Court invalidated the advertising provisions of the FDAMA, the Court found that “it would not make sense to require compounded drugs created to meet the unique needs of individual patients to undergo the testing required for the new drug approval process.” Furthermore, the Supreme Court expressly acknowledged the historical importance of traditional pharmacy compounding and openly questioned whether Congress could have intended to subject compounded drugs to the FD&CA’s new drug approval process. |
| 2002 | The 2002 Compliance Policy Guide addresses human drugs, but allows use of compounding from bulk for human drugs so long as the bulk ingredients are FDA-approved. |
| 2003 | The 2003 Compliance Policy Guide addresses animal drugs. FDA did not publish the Guide in Federal Register or invite public comment. More than 70 members of Congress wrote separately to the FDA reiterating policy concerns of the 2003 Guide regarding compounding from bulk substances. While the 2002 Guide permits compounding of human drugs from bulk substances under certain circumstances, the practice was entirely prohibited for animals, except for nine listed exceptions, by the 2003 Guide. Further, while the 1996 Guide acknowledges the occasional utility of compounding from bulk, this was absent in the 2003 Guide. Note the disparate treatment of human and animal compounding: Under the 2002 and 2003 Guides, “a pharmacist who compounds medication from bulk for ingestion by a horse is … subject to an FDA enforcement action, while the same pharmacist compounding medication from bulk for ingestion by the human rider of that horse is not.” |
| 2004 | FDA issued notice of revising the 2003 Guide but has never taken action to revise it. In 2005, 26 senators and 72 congressmen reiterated their displeasure over the agency’s failure to revise the 2003 Guide and subject it to notice and comment procedures. |
| 2006 | In Medical Center v. Gonzales (451 F.Supp.2d 854 (W.D. Tex. 2006)), the court, citing Algon and 9/1 Kg. Containers as additional support, held that compounded drugs are new animal drugs under the FD&CA, and unless the compounded drugs are exempt under the FD&CA’s AMDUCA provisions, compounded drugs are subject to FD&CA’s unsafe, adulteration and misbranding requirements. As with human drugs, the FD&CA contains no blanket “implicit exemption” for animal drugs produced by compounding. |
| 2007 | A FDA Center for Veterinary Medicine (CVM) update from May 2007 regarding concerns about supplies of pergolide for horses noted CVM’s efforts included trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a “valid veterinary prescription.” |
| 2011 | The court in Franck’s Lab distinguished Algon and 9/1 Kg. Containers. The court noted that neither case mentioned pharmacists or the practice of pharmacy. Algon and 9/1 Kg. Containers also predated a number of important legal developments relating to both the FDA’s regulation of compounding and the Chevron doctrine. The court held that in enacting the FD&CA in 1938, Congress did not intend to give the FDA per se authority to enjoin the longstanding, widespread, state-regulated practice of pharmacists’ filling a veterinarian’s prescription for a nonfood-producing animal by compounding from bulk substances. |
- See more at: http://www.mcguirewoods.com/Client-Resources/Alerts/2013/6/Compounding-Animal-Drugs-Bulk-Ingredients.aspx#sthash.ztsQGwz4.dpuf
Tinton Falls drug compounding business admits to health violations and will remain closed
Question of the Day :June 28, 2013 If Pharmacy is Pharmacy, then why aren't physicians and veterinarians working together toward best solution for state and federal compounding legislation?
And if pharmacy and pharmacy why is Congress considering the veterinary or animal side separate from the human side? Is the fact Congress is considering them separate the first indication that pharmacy is not pharmacy always--or that animal and human compounding pharmacy are different or should be treated different? If Congress treats animal and human compounding differently but the state boards of pharmacy treat them the same, won't this cause more confusion than there is now about compounding and also won't it make the laws hard to apply and comply with?
Job Openings for Compounding Pharmacist in Florida
Compounding Pharmacist
Healthcare & Medical - Bonita Springs, FL 34135
A newly acquired Pharmacy Compounding company in south west Florida has an opening for a pharmacist with experience compounding medications. This client company compounds customized pain medication according to the doctors specific requirements and ships within 24 hours, providing exceptional service rarely found in the marketplace.
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Job Opening for Compounding Sales Rep in Atlanta
Pharmaceutical Sales Representative-Atlanta
Healthcare & Medical - Atlanta, GA 30005
A newly acquired Phamacy Compunding company has an opening for a sales pro with experience selling to doctors in the "pain management" marketplace which would include neuro-muscular, rheumatoid and ortho physcians as well as other doctors that consistently have to manage pain. This client company compounds customized pain medication according to the doctors specific requirements and ships the n...
Tags for this job: Pharmaceutical sales, pain management, 1099 sales,compounding
Thursday, June 27, 2013
Reminder About Texas Pharmacy Association 2013 Conference and Expo--Compounding topic on pain management presented by Chris Simmons
3:00 p.m. – 5:00 p.m. CONCURRENT EDUCATION SESSIONS
HIPAA, HITECH and the New Texas Privacy Law (HB 300): What You Need To Know Now
Presented by Amanda Ellis, Attorney at Law
4:15 p.m. – 5:15 p.m. CONCURRENT EDUCATION SESSIONS
Pain Management Compounding Opportunities
Presented by Chris Simmons, R.Ph.
more information found here
The Government’s Use of Civil Forfeiture to Combat Health Care Fraud and Pill Mills in Florida Posted on June 25, 2013
By Christopher E. Brown, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Recently we have seen government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney General’s (AG) Office, and local sheriff and police departments use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.
Recently we have seen government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney General’s (AG) Office, and local sheriff and police departments use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.
continue reading here
Update on Michigan State Legislation Dealing With Compounding
The state of Michigan has not yet moved on compounding legislation; however, it’s expected that a bill will be introduced in the fall when legislators return from summer recess.
read more here
read more here
KUDOS to IACP!! It is Publishing a Wonderful Fax Facts For Its Member Each Week With Updates On Compounding Issues
to read this weeks updates (June 26, 2013) from IACP click here
Pharmacies Sending Sterile Compounds into Florida Need to Stay On Top of Law Changes
Special Sterile Compounding Permit Application Information
The Florida Board of Pharmacy is developing a new application which will be required for certain
pharmacies who will engage in the preparation of compounding sterile products. The application is not
yet available. You are not required to apply until Rule 64B16-28.100, Florida Administrative Code, is
finalized and adopted to include the new form DH-MQA 1270.
All permitees, with the exception of stand alone Special Parenteral/Enteral and Special
Parenteral/Enteral Extended Scope, that are currently compounding sterile products are required to
submit this application and will be issued a new Special Sterile Compounding permit number (in
addition to your usual pharmacy permit).
This website will be updated with information and instructions on how and when to submit your
application.
Those applying for this permit will be required to submit information from current policies and
procedures which will be reviewed before an inspection is requested
source found here
CMS Wants To Let Medicare Plans Restrict Potential Drug Abusers To Single Pharmacy
Key CMS and officials from the HHS Office of Inspector General on Monday (June 24) recommended that Congress let plans restrict high-risk Medicare beneficiaries from using multiple pharmacies to curb "doctor shopping" and reduce prescription drug abuse, a policy that some Medicaid programs and commercial plans use for beneficiaries with "drug-seeking behavior."
quoted from here
Pharmacy Practice News: "In Operating Room, a Switch To Prefilled Syringes Pays Off" in Puerto Rico
June 27, 2013
San Juan, Puerto Rico—Incorporating standardized, ready-to-use anesthesia medications in the operating rooms helped one hospital in St. Louis significantly increase proper labeling of medicines and reduce medication waste. Click here
Some patients not yet notified of possibly tainted shots -including people in Louisiana, Texas and Arkansas Jun. 27, 2013 6:27 PM
A month after a nationwide recall by a Tennessee drug compounder, 19 health facilities in three states have not yet notified all patients who were injected with a steroid that may have been contaminated with bacteria, fungus or both.
In a report issued Thursday, officials with the U.S. Centers for Disease Control and Prevention said the 19 facilities received methylprednisolone acetate from the Main Street Family Pharmacy in Newbern since Dec. 1, 2012.
Though the facilities lagging behind in notification were not identified, the CDC said that 10 are in Louisiana, eight in Texas and one in Arkansas, and that they either haven’t begun notifying patients or haven’t neared completion.
continue reading here
Copy of Proposed Consent Decree for Permanent Injunctive Relief in FDA v. Med Prep Consulting Regarding Permanent Injunction--showing agreement between FDA and Med Prep
can be viewed here. It appears that Med Prep and the FDA have agreed to the terms and conditions stated in the proposed consent decree. The court will most likely sign the order as is, but it is free to reject it or parts of it in some circumstances. As can be seen from reading this proposed consent decree for permanent injunctive relief, there are various requirements for Med Prep to do as corrective action. Thus, showing the reports of the FDA permanently putting Med Prep out of business are exaggerated. As noted in paragraphs 13-15 the requirement of who Med Prep must provide a copy of the decree to, including subsequently people associated with or people who buy Med Prep.
Other Actions for Junk Faxes Filed by Dr. Mark W. Sturdy
In previous post found here, the case against Lowlite Investments Inc d/b/a Olympia Pharmacy was highlighted. It appears the other actions previously filed by Dr. Mark W. Sturdy resulted in dismissals.
Mark W Sturdy is a party in 3 cases.
| 3:11-cv-03430-RM-BGC | Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. WM Healthcare Solutions, Inc. et al | filed 12/01/11 closed 01/15/13 |
| 3:11-cv-03452-RM-BGC | Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. ALLACCEM, Inc. et al | filed 12/30/11 closed 04/18/12 |
| 3:13-cv-03126-RM-BGC | Dr Mark W Sturdy v. Lowlite Investments Inc | filed 04/30/13 |
Update on Status of Dr. Mark W. Sturdy v. Lowlite Investments d/b/a/ Olympia Pharmacy--junck faxes from compounding pharmacies
| Defendant |
| John Does 1-10 |
| Date Filed | # | Docket Text |
|---|---|---|
| 04/30/2013 | 1 | COMPLAINT against John Does 1-10, Lowlite Investments, Inc., d/b/a Olympia Pharmacy ( Filing fee $ 350 receipt number 0753-1579273.), filed by Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Civil Cover Sheet, # 3 Summons)(Edelman, Daniel) (Entered: 04/30/2013) |
| 04/30/2013 | 2 | NOTICE of Appearance of Attorney by Daniel A Edelman on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Edelman, Daniel) (Entered: 04/30/2013) |
| 04/30/2013 | 3 | NOTICE of Appearance of Attorney by Dulijaza Julie Clark on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Clark, Dulijaza) (Entered: 04/30/2013) |
| 04/30/2013 | 4 | MOTION to Certify Class by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Edelman, Daniel) (Entered: 04/30/2013) |
| 04/30/2013 | 5 | MEMORANDUM in Support re 4 MOTION to Certify Class filed by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Edelman, Daniel) (Entered: 04/30/2013) |
| 04/30/2013 | 6 | NOTICE of Appearance of Attorney by Michelle R Teggelaar on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Teggelaar, Michelle) (Entered: 04/30/2013) |
| 04/30/2013 | 7 | MOTION to Continue and enter Plaintiff's Motion for Class Certification by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Clark, Dulijaza) (Entered: 04/30/2013) |
| 05/02/2013 | TEXT ORDER by Magistrate Judge Byron Cudmore: Plaintiff's Motion to Enter and Continue Plaintiff's Motion for Class Certification 7 ALLOWED in that Plaintiff's Motion for Class Certification 4 will remain of record and taken under advisement until the parties are at issue. The ECF response date from Motion 4 is stricken. Plaintiff to take steps to serve Defendants. (LB, ilcd) (Entered: 05/02/2013) | |
| 05/15/2013 | 8 | Summons Issued as to Lowlite Investments Inc.. Original returned to attorney for service. (MJ, ilcd) (Entered: 05/15/2013) |
| 06/07/2013 | 9 | SUMMONS Returned Executed by Mark W Sturdy. Lowlite Investments Inc served on 5/30/2013, answer due 6/20/2013. (Clark, Dulijaza) (Entered: 06/07/2013) |
| 06/19/2013 | 10 | MOTION For Leave to Participate in Case While Application For Admission is Pending by Defendant Lowlite Investments Inc. Responses due by 7/8/2013 (Tingley, Amy) (Entered: 06/19/2013) |
| 06/19/2013 | 11 | Consent MOTION for Extension of Time to File Response/Reply to Class Action Complaint by Defendant Lowlite Investments Inc. Responses due by 7/8/2013 (Tingley, Amy) (Entered: 06/19/2013) |
| 06/21/2013 | 12 | ORDER by U.S. Magistrate Judge Byron Cudmore: Motion for Leave to Participate in Case While Application for Admission is Pending 10 ALLOWED in part. See written order. (LB, ilcd) (Entered: 06/21/2013) |
| 06/21/2013 | TEXT ORDER by Magistrate Judge Byron Cudmore: Motion for Extension of Time to File Answer or Other Response to Class Action Complaint 11 ALLOWED without objection. Extension granted to 7/5/2013. (LB, ilcd) (Entered: 06/21/2013) |
other post here and here
California Senate Committee on Appropriations to Meet July 1, 2013 Regarding A.B. 1045 Compounding Legislation on Recalls
CALIFORNIA
The Senate Committee on Appropriations will meet 7/1/2013 to discuss A.B. 1045, which requires a pharmacy that issues a recall notice for a sterile compounded drug dispensed or intended for use in California to contact the recipient pharmacy, prescriber or patient and the California State Board of Pharmacy within 12 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death. Kelsey Lovell at kal@stateside.com
quoted from here
Update on Status of S. 959- Senate HELP Committee Version of Compounding Legislation: Pharmaceutical Compounding Quality and Accountability Act--Place on Calendar General order no 89
S.959 — 113th Congress (2013-2014)
BILL
| Latest Title: | Pharmaceutical Compounding Quality and Accountability Act |
|---|---|
| Sponsor: | Sen. Harkin, Tom [D-IA] |
| Cosponsors: | 5 |
| Latest Action: | 06/19/2013 Placed on Senate Legislative Calendar under General Orders. Calendar No. 89. |
| Tracker: source found here and here Reports filed yesterday source found at www.gop.gov |
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