Second Question of the Day July 30, 2013 Should Congress Pass Senate Bill 959 Without Addressing Veterinary and Animal Issues Since Pharmacy is Pharmacy And Since Report on Animal Compound Drugs Is Not Due to Congress Before November 2016?

Home - My Health, My Compounds

Home - My Health, My Compounds

Contaminated steroids cause two more deaths in Livingston County

LIVINGSTON COUNTY (WKZO) -- State health officials say the tainted steroids that were shipped to four Michigan Clinics last year from a compounding lab in Massachusetts, continue to kill and maim.

Two more people have died from the tainted shots. A 75-year-old man and a 64-year-old woman from Livingston County, bringing the total who have died in Michigan to 22.

Three of them come from Southwest Michigan and received their shots at a northern Indiana clinic.

264 michiganders suffered symptoms from the tainted shots and many of them continue to require  regular treatments. 

Angela Minicuci with the Michigan Department of Public Health says Michigan has been hit harder than any other state.  Its inspired doctors to find treatments to prevent the injections from blossoming into full blown cases of fungal meningitis.

quoted from here

 

American Society of Health-System Pharmacists (ASHP) July 30, 2013 Letter to the Senate

July 30, 2013
The Honorable Tom Harkin, Chairman
The Honorable Lamar Alexander, Ranking Member
The Honorable Pat Roberts
The Honorable Al Franken
The Honorable Barbara Mikulski
Senate Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20515
Dear Chairman Harkin, Ranking Member Alexander, and Senators Roberts, Franken and Mikulski:
On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to express our
strong support for S. 959, the “Pharmaceutical Compounding Quality and Accountability Act” of 2013.
This bipartisan legislation will address the regulatory gaps that exist with respect to sterile compounding
and help prevent a tragedy such as the meningitis outbreak of 2012 from occurring in the future. In
addition, it will assure health-system pharmacists, physicians and other purchasers of compounded
products that compounding manufacturers have been inspected by the Food and Drug Administration
(FDA) and adhere to Current Good Manufacturing Practices.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy
technicians, and pharmacy students who provide patient care services in hospitals, health systems, and
ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication
use and enhance patient safety.
S. 959 would create a new category of registration through the FDA for large scale commercial
compounders now referred to as compounding manufacturers. We believe this will close the regulatory
gap and jurisdictional uncertainty between FDA and state boards of pharmacy while maintaining state
oversight of the practice of pharmacy, which includes traditional pharmacy compounding.
Furthermore, we are pleased to see that hospitals and health systems—as purchasers of products from
compounding manufacturers—are treated as traditional compounders. Hospitals and health systems
are fully accountable for the comprehensive care of their patients and no medication, compounded or
otherwise prepared, is administered to the patient unless there is a patient-specific medication order.
Compounded medications prepared by hospital pharmacy departments and all other medications used
in health systems are prescribed or ordered based on established relationships with the medical staff.Senate Committee on Health, Education, Labor and Pensions
July 30, 2013
Page 2
We firmly believe this bipartisan legislation recognizes shifts in the current environment and provides
FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a
service to hospitals and other providers who administer them to patients, rather than a traditional
pharmacy compounder who prepares sterile compounded products pursuant to a prescription, or in
limited quantities for anticipatory use. In addition, we are grateful the Committee recognized the
valuable role that traditional compounding pharmacies play in patient care, and that the bill keeps
traditional compounding pharmacies (including hospitals and health systems) under state board of
pharmacy purview.
Finally, ASHP strongly supports the exception for compounding commercially available products that are
on the FDA’s drug shortage list. Shortages of critical medications continue to present challenges as
caregivers scramble to obtain medications in short supply. We believe the allowance to compound
products in short supply will help address this challenge.
Again, ASHP thanks you for your leadership in addressing the regulatory gaps in non-patient specific
sterile compounding and ensuring that entities preparing sterile products and introducing them into
interstate commerce are properly inspected by and accountable to the FDA. We hope the full Senate
will consider this legislation soon and look forward to working with you and the full Congress to pass this
critical legislation. If you have any questions or need additional information, please contact Joseph Hill
on my staff at 301-664-8710 or jhill@ashp.org.
Sincerely,
Paul W. Abramowitz

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Compounding Legislation: Your Voice Urgently Needed Now! - July 30, 2013

It’s hard to believe that after the many deaths and illnesses associated with the alleged practices at the New England Compounding Center last Fall, the bipartisan Senate bill (S.959) that is designed to prevent a tragic repeat could be facing tremendous opposition.

ASHP strongly supports this legislation. Yet, it appears that opposition to the Senate bill is forming, because certain interests want to protect the status quo, which we believe could be at the expense of protecting patients from another compounding tragedy.

These special interests are also threatening to severely limit how pharmacists in hospitals and health systems serve and protect patients. ASHP supports the provision in the bill that exempts health systems from being designated as compounding manufacturers. Without this important exemption, many hospitals and health systems would have to register with the Food and Drug Administration (FDA) as compounding manufacturers, since anticipatory compounding is required for us to meet the needs of our sickest and most vulnerable patients.  Also, without the exemption, many hospitals would not be able to prepare compounded preparations and send them to their wholly owned outpatient clinics, surgery centers, smaller inpatient facilities, and medical office practices.   This is a critical distinction, based on the fact that hospitals and health systems are fully accountable for the comprehensive care of the patient – as compared to a compounding manufacturer that sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.

This distinction between health systems and compounding manufacturers is based on very important differences:

• Hospitals and health systems have well-established quality improvement, infection control, and risk management committees, as well as adverse event monitoring and reporting systems.

• Health systems must comply with the Centers for Medicare & Medicaid Services (CMS) Hospital Conditions of Participation and are accredited by quality improvement organizations such as The Joint Commission and DNV Healthcare, both of whom have deemed status with CMS.

• Hospitals and health systems have Pharmacy and Therapeutics Committees that control approved drug formularies.

We must protect the important work that pharmacists do in hospitals and health systems to take care of their patients.  In addition, hospital pharmacists and other providers must be assured that when they need to purchase compounded products from outside suppliers that they can expect to receive products that are safe and effective for their patients.  Therefore, we must enact into law urgently needed regulatory control over compounding manufacturers to prevent another tragedy.

You can make a difference. Your voice really matters to your elected Senators and Representatives in Congress!

ASHP has made it as easy as just a few clicks on your computer for your voice to be heard.

Go to ASHP’s advocacy page and make a difference for patient safety!

Tell your Senators that you want them to vote “YES” in support of S. 959.  This legislation creates a new category, “compounding manufacturer,” which will be regulated by the FDA. Hospitals and health systems are considered traditional compounders in the legislation and will remain under the purview of state boards of pharmacy and other accrediting bodies.

Tell your Representative that the House should take a similar approach to the legislation and give the FDA the tools it needs to prevent another tragedy.

Your support today can go a long way in getting this important legislation passed!

- See more at: http://www.ashpintersections.org/2013/07/compounding-legislation-your-voice-urgently-needed-now/#sthash.JPRzl7wj.dpuf

IACP Update on S. 959

 IACP’s team of seven full-time Washington, D.C. lobbyists continue to find no evidence in their meetings with key Hill offices this morning that there will be a Senate vote this week on S. 959. All intelligence is indicating that a vote will come after the August recess. In the meantime, IACP’s Vice President of Government Affairs Sarah Dodge reports that IACP continues to work with several Senate offices who have reached out to IACP on amendment language to the bill, which also indicates that a vote is more likely after the recess. Please emailiacpinfo@iacprx.org if you have any questions on this information.

IACP Perspective: Why the Current Draft of S. 959 is Still Unworkable

• The compounding community has been collaborating with lawmakers and their staff on the development of legislation that will ensure we never have another NECC.
• The bill that has emerged from the Senate HELP Committee, Senate 959, will not protect patient safety and therefore IACP and the compounding community is not supporting it at this time.
• The bill exempts hospitals, health systems, and pharmacy benefit managers from the very protections it is putting in place, and we believe that these large exemptions will create safety gaps.  We believe that every patient should be assured of the same level of safety, whether they get their compounded medications from a pharmacy, a hospital, or a mail order pharmacy.  
• The bill also could interfere with patient access to compounded medications.  For instance, it prohibits the re-packaging of certain medications even when those re-packaged medications are far less costly.  It creates restrictions on anticipatory compounding and office use,  two methods for patients receiving medications when they need them.

Posted 7.30.13

From the FDA Blog--Dietary Supplements Containing Unsafe Food Additive Destroyed

In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA). 

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week. 

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths. 

continue to read here

 

FDA Law Blog--Ricardo Carvajal, July 301, 2013 wrote Interesting piece entiled Might You Be An Imposter for Purposes of FSMA's FSVP REquirement? Now You Know

FDA Law Blog - Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.

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Read here Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.

Question of the Day July 30, 2013 Will the US Senate Be Successful in Using "unanimous Consent" to Pass Senate Bill 959, The Pharmaceutical Compounding Quality and Accountability Act.?

Unanimous Consent is a procedure prevents any debate, prohibits amendments, and no Senator is forced to go on the record and affirmatively support the bill.   The Senate Website does not currently have the bill listed for consideration next Monday but rumors are that is when it may be considered.  At least one U.S. Senator, Tom Colburn from Oklahoma, has indicated he will not agree to unanimous consent of the bill.  Stay tuned  to the blog for more information.

 

National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy

Pharmacists Group Lobbies Against Senate Compounding Bill

Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy and is relying on a parliamentary continue to read here

Imprimis Pharmaceuticals Innovates Back to Basics With Compounding

CHICAGO(TheStreet) -- Although the number of people needing custom medicines and new ways to take them is growing exponentially, there are few pharmaceuticals companies positioned to take advantage of the trend.

Enter Imprimis Pharmaceuticals (IMMY_).

The California company has a unique combination of delivery methods and partner that make it worthy of attention as more people worry about the harmful long-term effects of certain mass-produced medications.

 

For instance, nonsteroidal anti-inflammatory drugs such as Advil, Motrin and Aleve have been shown in studies to cause stomach ailments. "Gastritis, esophageal reflux disease and bleeding ulcers are all problems that can develop from NSAIDs," says Robert Hoffman, chief of rheumatology at the University of Miami's Miller School of Medicine.

Such mass-produced drugs have developed into a multibillion-dollar industry since industrialization became the norm in the 1950s. Imprimis CEO Mark Baum looks to the era before that, though, when it was common for pharmacists to blend custom prescriptions for individual customers. He thinks his company can make strides to revolutionize modern drug compounding, improving their quality and moving them swiftly through Food and Drug Administration approvals.

Imprimis has a drug delivery technology that ensures site-specific treatment via a topical cream preparation, including with Impracor, a drug entering Phase 3 approvals from the FDA in the third quarter of 2013, and a variety of others that "will enable the delivery of drugs intravenously... as well as through the mouth, through the nose, and trans-vaginally, which gives us the ability... to affect men's health, women's health, as well as [avoid] gastrointestinal conditions," Baum says.

The technology could revolutionize the way pharmaceuticals, especially analgesics, are accessed and administered, Baum says.

Imprimis already uses its Transdel technology to deliver an NSAID called ketoprofen via a cream that is rubbed on the skin, where it acts on the underlying tissues to ease pain.

Imprimis' partner in the revolution is the Professional Compounding Centers of America, "the largest player in the compounding pharmacy industry in North America," Baum says. "The PCCA has over 10,000 proprietary compounded drug formulations and ... more than a dozen proprietary drug delivery technologies," and Imprimis has an exclusive relationship with the PCCA to develop and commercialize its library of patented formulations and technologies -- to mine the library for drugs that can be developed internally or through a development partner.

This library has the potential to provide Imprimis with multiple large-market drug candidates annually, Baum says, saving cost and time. Since all the formulations have been used by the PCCA's patients, ample data are available on their performance and safety that Imprimis can use in putting drugs through the federal 505(b)(2) approval pathway.

"These are drug formulations that are typically sold by ... compounded pharmacies all over the country. Imprimis is taking them through a traditional regulated FDA process in order to bring them to the market," Baum says.

continue to read here

Tennessee board adds new rules for compounding pharmacies

Tennessee board adds new rules for compounding pharmacies

Duane Morris Has Done Another Great Job of Summarizing the Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

It can be read here:  United States: Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

Last Updated: July 30 2013

Article by Rachael G. Pontikes and Elinor L. Hart

Duane Morris LLP

MUST READ--July 26, 2013 FDA Soliciting Input on Global Supply Chain Provisions in FDASIA --Meeting in August will address compounding questions

In a recent post from the FDA Voice Blog, Office of Compliance Director for FDA's Center for Drug Evaluation and Research (CDER) wrote about the agency's future activities to help combat the globalized supply chain—in particular about the Food and Drug Administration Safety and Innovation Act (FDASIA).

In addition to sharing his priorities about resolving problems regarding drug compounding, Office of Compliance Director Howard Sklamberg noted that one of his main priorities is the globalized supply chain. He noted how today, "nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources." He also recognized that a "growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging."

He also identified that "counterfeit drugs are proliferating around the world and sometimes even entering the U.S. supply chain" and the "ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality."

Confirming other priorities of the U.S. Department of Justice and recent FDA activities, Sklamberg also noted that "poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs," and another agency priority will be to "ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA's strict standards of quality and that they remain in adequate supply."

- See more at: http://www.policymed.com/2013/07/fda-soliciting-input-on-global-supply-chain-provisions-in-fdasia.html#sthash.qri27XjK.dpuf

Two more Michigan deaths linked to tainted steroid injections July 29, 2013

Two more Michigan residents have died in connection with a fungal meningitis outbreak that began last year and has sickened about 750 people nationwide.

A 64-year-old woman and a 75-year-old man, both of Livingston County, died after receiving tainted steroid injections. State health officials confirmed July 22 that their deaths were linked to the outbreak, said Angela Minicuci, public information officer for the Michigan Department of Community Health.

Minicuci said both people had developed epidural abscesses, or infections at the site of injection.

Beginning in May 2012, the Massachusetts-based New England Compounding Center shipped 17,000 vials of contaminated preservative-free methylprednisolone acetate to facilities in 23 states, leading to the deadly outbreak. Steroid shots are a relatively common treatment for back pain.

continue  to read here

 

Court Ruling Threatens Drug Shortage Remedy--May Effect K-V and Compounding Issues

Court Ruling Threatens Drug Shortage Remedy

By JILL WECHSLER | Published: JULY 29, 2013

The Food and  Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the Court of Appeals for the District of Columbia. The ruling of July 23, 2013 also raises broader questions about when and how FDA can “exercise regulatory discretion” in deciding certain  policy and enforcement issues.

According to a unanimous decision by a three-judge panel, FDA’s action to permit import of thiopental from an unregistered foreign establishment was “not in accordance with law,” even though the aim was to address the shortage of a needed medicine. The ruling in Cook et al v. FDA (case No. 12-5176), which upholds a previous decision by a federal district court, involves a shortage of thiopental sodium, which created serious problems for state  

law enforcement

officials seeking to use it in delivering lethal injections. A group of death row inmates from three states filed suit, claiming that FDA violated the law by improperly allowing shipments of a misbranded and unapproved new drug to enter the U.S.

The Appeals Court specifically rejected FDA’s argument that it can legally address drug shortages by permitting the import of drugs approved by other regulatory authorities. Among its various tools for combating serious short supply situations, FDA also cites authority to allow distribution of a product suffering from quality problems, but found by the agency to “not cause undue risk to patients.” Other FDA relief strategies are to work with sponsors to resolve manufacturing issues, expedite inspections and reviews of short supply products, identify additional manufacturers willing to initiate or increase production, extend product expiration dates, and help firms qualify new sources of raw materials.

FDA has permitted unapproved imports 17 times in recent years, according to its announcement in May on authorizing the import of injectable total parenteral nutrition (TPN) solutions. These products are desperately needed by hospitals to treat premature infants unable to eat or drink, as well as cancer patients undergoing gastrointestinal surgeries. In this case, FDA authorized Fresenius Kabi USA to import TPN products from its Norway plant. The agency took this step after American Regent/Luitpold shut down operations at the end of 2012 to address quality issues that left particulate matter in injectable products. In this and other cases, FDA says that it evaluates the overseas drug to ensure that it is of adequate quality and informs doctors of the status of the imported product.

The July Appeals court ruling is regarded as a victory for death penalty opponents, who had pressured other manufacturers to discontinue production of thiopental and other “death drugs.” Yet state officials had urged FDA to appeal last year’s district court ruling in order to obtain needed supplies to carry out executions according to law. In that earlier lower decision, the judge accused FDA of hypocrisy, pointing out that the agency prevents consumers from purchasing medicines over the Internet because it deems the products misbranded and unapproved. The Appeals Court agreed, noting that FDA can address specific shortages through other strategies, such as designating an unapproved foreign drug as investigational to allow its importation.

This legal challenge to FDA use of enforcement discretion also could provide support for K-V Pharmaceuticals, which is challenging FDA’s failure to block competitors from producing the pre-term birth drug Makena (hydroxyprogesterone caproate injection). In this case, explains attorney Kurt Karst of Hyman, Phelps & McNamara, the D.C. District Court has sided with FDA, stating that the agency has the right to refuse to take action to stop pharmacy compounding of the drug. Kurt speculates in the FDA Law Blog that the recent Cook case will have a “huge effect” on how it deals with drug shortages [see www.fdalawblog.net July 23, 2013].

 

quoted from here

Pharmacy Compounding Primer

Pharmacy Compounding Primer
for Physicians
Prescriber Beware
Sarah Sellers1
and Wulf H. Utian2
1 q-Vigilance LLC, North Barrington, IL, USA
2 Case Western Reserve University, Cleveland, OH, USA

this article can be read here

Drug Topics Committee calls for Senate action on updated compounding bill -

 

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The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee called for the Senate to act on its bill to provide clear oversight of compounding manufacturers, following the 2012 fungal meningitis outbreak, and to protect the U.S. drug supply chain from counterfeiting and theft, according to a HELP Committee statement on July 25.

 The updated legislation, S. 959, known as the “Pharmaceutical Quality, Security, and Accountability Act,” includes the “Pharmaceutical Compounding and Quality and Accountability Act” (Title 1) and the “Drug Supply Chain Security Act” (Title 2).

Under Title 1, the bill distinguishes between traditional compounding for humans that will continue to be regulated by state boards of pharmacy and compounding manufacturers that will be regulated by FDA. Compounding manufacturers are defined as manufacturers that produce sterile products without, or in advance of, a prescription and then sell across state lines.

Title 1 still allows traditional compounding pharmacies to compound for healthcare practitioners for office use, but sets the limit to 10% of products that the compounding pharmacy can dispense. Within 14 days of dispensing, the pharmacies must reconcile the names of patients who will receive the office use product, the HELP Committee noted.

FDA will be able to develop a list of drugs that cannot be compounded and bulk ingredients that cannot be used in compounded products. Also, there is be streamlined notice for compounding during a drug shortage, which allows for a single notice by the compounder that is copying an FDA-approved drug, according to Title 1.

Compounding manufacturers will only be able to compound nonsterile drugs from a list developed by FDA. However, they will be allowed to repackage biologics without a prescription. All compounding manufacturers will be listed on the FDA’s website, including the state where they are registered. When compounding manufacturers register, they must include a list of products that they produced in the last 6 months.

“This bill is about saving lives, plain and simple. The most recent compounding outbreak resulted in 61 deaths. More than 700 people continue to suffer from tainted compounded medicine. We must find reasonable ways to prevent further death or illness due to confusion over who has oversight of compounding pharmacies,” said Sen. Pat Roberts (R-Kan.) during the release

JUL 29, 2013

 of this updated bill.

Under Title 2, within 4 years of enactment of this legislation, all prescription drugs will be tracked from the manufacturer to the pharmacy. Manufacturers will have to serialize their products, provide transaction information, transaction history, and transaction statements in an electronic format to their trading partners.

“This bill establishes a uniform system that improves the security and safety of drugs for consumers,” Sen. Richard Burr (R-N.C.) said during the release of the updated legislation.

quoted from here

 

Senators Propose Amendments To S. 959-RX Trace

As many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable.

Most significantly, manufacturers would be required to provide their transaction information, transaction history, and transaction statement in a single document only in electronic formstarting 4 years after enactment.  Prior to that point they could provide it in either electronic or paper form.  What’s interesting about this change is how it would trickle down the supply chain.

On the surface you would expect that the authors of the bill would need to include a similar requirement on the wholesalers, dispensers and repackagers, but they did not do that.  It is not necessary because, wholesalers were already required to receive that information from the manufacturer.  Once the manufacturer can only provide it in electronic form 4 years after enactment, then wholesalers must be able to receive and store it electronically to remain in compliance at that same time.

Once wholesalers begins to receive the transaction information, history and statements from the manufacturers in electronic form it appears that the bill would allow them to convert them to paper whenever they need to pass them on to their customer.  That is, at least until the enhanced drug distribution security provisions would kick in 10 years after enactment.  By that time, everyone would have to create, store and exchange these documents electronically.

But this brings me to the next significant amendment to the bill.  There is a new and poorly worded section under the Product Tracing section called “Trading Partner Agreements”.  The section says:

continue to read here

FDA CDER Schedule for Guidance Agenda: for 2013

Guidance Agenda:
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2013
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY —Advertising
• Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials
including Submissions in Electronic Format
CATEGORY — Animal Rule
• Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics
• Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence
Studies for Orally Administered Drug Products Submitted in New Drug Applications General
Consideration

CATEGORY — Biosimilarity
• Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein
Products
CATEGORY —Chemistry
• Allowable Excess Volume and Labeled Vial Fill Size
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in
Abbreviated New Drug Applications
• CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological
Products
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Elemental Impuritiesin Drug Products Marketed in the United States
• Immunogenicity Considerations for Low Molecular Weight Heparin
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation Version: 07.26.13. Guidances with (*) indicates an addition since previous posting.
CATEGORY —Clinical/Antimicrobial
• Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of
Serious Bacterial Disease
• Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
• Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• Pulmonary Tuberculosis: Developing Drugs for Treatment
CATEGORY —Clinical/Medical
• Alzheimer’s Disease: Developing Drugs for the Treatment of Early State Disease
• Common Issues in Drug Development for Rare Diseases
• Developing Drug and Biological Products for Analgesic Indications
• Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
• Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
• Standards for Clinical Trial Imaging Endpoints
CATEGORY – CMC and CLINICAL/MEDICAL
• Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY —Clinical Pharmacology
• Bioanalytical Methods Validation

CVM Offices Instructional Videos

CVM Offices Instructional Videos

Pharmalot ed Silverman Reports that Pharmacists Group Lovvies Against to Seante Compounding Bill

Posted Mon, 07/29/2013 - 9:11am by Ed Silverman 0

PHARMACISTS GROUP LOBBIES AGAINST TO SENATE COMPOUNDING BILL

Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is “anti-pharmacy” and is relying on a parliamentary maneuver that may stifle further debate.

continue reading here

Jul 29, 2013, 6:45am EDT Judge in NECC Says victims Can Sue Health Care Providers

Craig Douglas

Managing editor/online vertical products and research-Boston Business Journal

Email  | Twitter

A U.S. bankruptcy judge has cleared the way for victims in the deadly meningitis outbreak that originated in a Massachusetts compounding pharmacy to sue the health care facilities and providers who prescribed the tainted steroids at the center of the controversy.

According to Reuters.com, there were approximately 65 health care providers and doctors in Tennessee who were included on the customer list of the now-insolvent New England Compounding Center in Framingham. The pharmacy and its affiliates stand accused of shoddy operating practices and other regulatory violations that led to the alleged shipment of fungus-tainted steroids to health care providers throughout the country.

The Reuters report said U.S. BankruptcyJudge Henry J. Boroff on July 24 declared NECC insolvent, meaning Tennessee victims can file product-liability claims against medical providers who prescribed the steroids that led to the meningitis outbreak. The newswire said that without the insolvency declaration, the victims would only have been able to pursue professional or medical negligence claims, according to Tennessee law.

The meningitis outbreak has resulted in 15 deaths and 153 meningitis-related cases in Tennessee, according to the U.S. Centers for Disease Control and Prevention.

The outbreak was detected late last year and resulted in a firestorm of legal and civil suits filed against NECC, which filed for Chapter 11 bankruptcy protection shortly after the outbreak made national headlines.

quoted from here