A Confusing Attempt to Cure Compounding Pharmacies By Paul M. Barrett September 27, 2013

Remember the panic about compounding pharmacies? These are state-licensed retail businesses that mix and sell medications, but without the federal safety approval required for mass-produced drugs. No? How about the scandal last yearinvolving a Massachusetts pharmacy whose tainted back-pain steroids led to hundreds of serious infections and more than 60 deaths, many related to meningitis?

Oh, yes, that you recall. Scary stuff.

Now that you’re focused, here’s the news: Congress has finally moved to give the Food and Drug Administration greater authority over compounding pharmacies. This week, negotiators from the House and Senate came up with a compromise billdesigned to prevent another fiasco like last fall’s misadventure with the since-closed New England Compounding Center in Framingham, Mass.

Unfortunately, the compromise seems convoluted, requires only voluntary participation by compounding pharmacies, and has already provoked a vow of resistance from the targeted businesses. In other words: more confusion ahead.

Lawmakers said they aimed to give the FDA greater authority to oversee and inspect compounding pharmacies in the way the agency already supervises traditional drug manufacturers. In a twist, though, compounding pharmacies wouldn’t be required to submit to this oversight. The proposed legislation would rely on market forces to provide the incentive for pharmacies to open up to the FDA. Presumably, doctors and hospitals would prefer to acquire specially designed remedies from businesses willing to host FDA inspectors.

Well, maybe. Or maybe cut-rate, low-quality pill-and-serum mills would remain in the shadows, hoping to sell to just enough customers to stay in business. Given the terrifying experience in Massachusetts last year, it seems odd that the option would remain with the manufacturers.

continue to read here

  IACP Member Alert: IACP: COMPROMISE COMPOUNDING BILL WILL NOT ADVANCE QUALITY AND SAFETY!

The International Academy of Compounding Pharmacists (IACP) believes that the compromise compounding bill that has emerged from Congress will not protect the American public; contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year.

Click here to read more http://bit.ly/18vhnx9

Question Three of the Day, September 27, 2013, What happens when you try to apply the Compounding Quality Act (a part of the Drugs Quality and Security Act) to a situation in the future that is like the NECC outbreak?

Assume NECC does not elect to be an outsourcing facility.  Assume that the FDA nonetheless after receiving information from the states attempts to take enforcement action against NECC.  What do you think NECC's response would be?  We are so glad you showed up to save all these people FDA, come on in, look around, gather evidence, do your job??  I think not.  I think you would get the same response as in the past--FDA  we didn't elect to be under your authority so go away--FDA would then have to go to court and hope for the best! And hope that they could get court action before anyone died.

Second Question off the Day September 27, 2013, Did any of the major players--FDA, IACP, or the Working Group On Pharmaceutical Safety effected by and arguing for or against federal compounding legislation get what they wanted? Are any of them pleased with this legislation?

d

Question of the Day September 27, 2013 How can a voluntary federal law covering compounding pharmacies possibly work? Wouldn't that be like saying the Controlled Dangerous Substance Act is now voluntary?

Congress Clarifies Drug Compounding, Tracking Policies

Congress Clarifies Drug Compounding, Tracking Policies

NCPA Urges Passage of Compounding Reform, Drug Security Bill September 27, 2013

ALEXANDRIA, Va., Sept. 27, 2013 /PRNewswire-USNewswire/ — The National Community Pharmacists Association (NCPA) today endorsed The Drug Quality and Security Act in letters to House and Senate leaders urging approval of the measure.

The bill has two major provisions. First, it would preserve patient access to customized medications prepared by independent community pharmacies while taking steps to enhance protections against a recurrence of the meningitis outbreak linked to the New England Compounding Center (NECC) and exacerbated by the lack of oversight by the Food and Drug Administration (FDA) and Massachusetts state health officials. Second, it would establish a uniform standard for securing the nation’s pharmaceutical supply chain.

The legislation would accomplish both goals by preserving current law and creating a voluntary “outsourcing facility” registration, and reflects a bipartisan, House and Senate agreement announced earlier this week by U.S. House Energy & Commerce Committee Chair Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) and U.S. Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.). The efforts of Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas), Diana DeGette (D-Colo.), and Sen. Pat Roberts (R-Kan.) also proved critical to reaching a final compromise.

“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain,” NCPA CEO B. Douglas Hoey, RPh, MBA wrote in his letter to lawmakers. “When off-the-shelf manufactured drugs are not an option, community pharmacists prepare or compound customized medications for individual patients. NCPA commends Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.”

Throughout the process, NCPA was heavily engaged in advocating for common-sense solutions that promoted safety, preserved access for patients, and protected small business community pharmacies from burdensome, unfunded mandates. Some of those efforts were highly visible such as when a NCPA official and a NCPA member and pharmacy owner delivered expert testimony before Congressional hearings or when NCPA articulated these views in the media. In other instances, NCPA members and staff lent their expertise and technical advice through countless meetings and other interactions with policymakers.

As a result, in The Drug Quality and Security Act, Congress developed balanced legislation to address critical needs while avoiding provisions in previous legislation that, while well-intended, was problematic for community pharmacists.

“Independent pharmacies have a long and successful history of protecting patient safety while preserving patient access to vital medications,” Hoey concluded. “This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain.”

The National Community Pharmacists Association (NCPA®) represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists. To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com/.

SOURCE National Community Pharmacists Association (NCPA)

Letters of Support for Drug Quality and Security Act

Letters of Support for H.R. 3204, the Drug Quality and Security Act

September 27, 2013

   

Allergy & Asthma Network Mothers of Asthmatics

American Society for Radiation Oncology

American Society for Reproductive Medicine

American Society of Clinical Oncology

American Society of Health-System Pharmacists

Bladder Cancer Advocacy Network

Blue Ribbon Advocacy Alliance

CancerCare

Cancer Support Community

Caregiver Action Network

CreakyJoints.org

Fight Colorectal Cancer

Generic Pharmaceutical Association

Global Healthy Living Foundation

Healthcare Distribution Management Association

Institute for Nurse Practitioner Excellence

International Myeloma Foundation

Kidney Cancer Association

LIVESTRONG Foundation

Lymphoma Research Foundation

MD Support

Men’s Health Network

National Coalition for Cancer Survivorship

National Lung Cancer Partnership

National Patient Advocate Foundation

North American Menopause Society

Ovarian Cancer National Alliance

Pancreatic Cancer Action Network

Prevent Cancer Foundation

Pfizer

Richie's Specialty Pharmacy

Sarcoma Foundation of America

Society for Women’s Health Research

StopAfib.org

Susan G. Komen Advocacy Alliance

Terri Lewis, Meningitis Outbreak FB Community Manager

The Children's Cause for Cancer Advocacy

The Leukemia & Lymphoma Society

The National Community Pharmacists Association

UPS

Us TOO International Prostate Cancer Education and Support Network

Letter Type: 

Inbox

Want to know who is Supporting Congress' Agreement on the Drug Quality and Security Act--Read this

WHAT THEY’RE SAYING: DRUG QUALITY AND SECURITY ACT

September 27, 2013

   

Leading National Health and Patient Organizations Strongly Support Breakthrough Bipartisan Agreement to Improve Drug Safety

“This compromise legislation addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain.” - NCPA

WASHINGTON, DC – Earlier this week, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Committee Chairman Tom Harkin (D-IA) announced bipartisan, bicameral legislation to address high-risk drug compounding practices and strengthen America’s pharmaceutical supply chain. H.R. 3204 – the Drug Quality and Security Act – builds upon the Energy and Commerce Committee’s extensive efforts to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

In addition to the bill’s introduction, momentum continues to build around this important effort as dozens of groups have voiced their support. A sampling of the support is provided below:

National Community Pharmacists Association (NCPA)

“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain. NCPA applauds the House for moving this legislation in expeditious fashion, and urge members to vote in favor of this bipartisan compromise. … NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.”

Cancer Leadership Council (On Behalf of 21 Cancer Organizations)

“Cancer patients and providers support a pharmaceutical distribution system that will protect against the counterfeit medicines that have put cancer patients at risk in the recent past. Distribution system protections

another recall

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

By Newsroom America Feeds at 11:00 am EasternUPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe

Highlights of Federal Compounding legislation Draft

Among other highlights, the legislation:

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

quoted from here

Bicameral Pact Uses Market Forces To Push Compounders Toward Voluntary Federal Oversight Lawmakers late Wednesday (Sept. 26) struck a bicameral, bipartisan drug compounding agreement that departs from previous proposals by ditching volume limits and a three-part test in favor of a voluntary regulatory scheme for sterile compounders.

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Are we there yet? Bicameral Congressional group posts news about a track-and-trace agreement September 26, 2013

Regulation of compounding pharmacies will be included in the new Drug Quality and Security Act

 

Confirming that, indeed, Congressional committees have been working hard behind the scenes to completea compromise draft legislation that will encompass both the longstanding effort for national rules on trackingpharmaceutical shipments, and the more recent effort to give FDA more authority to regulate compounding pharmacies, several Congressmen issued news releases on Sept. 25 announcing their success. The actual bill remains to be revealed, at least as of early on Sept. 26. 

 

Senator Tom Harkin (D-IA), chairman of the Senate Health, Education and Labor Committee, issued astatement that commended “the bipartisan spirit that brought this compromise proposal together” in the form of what will now be called the Drug Quality and Security Act.  “Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding,” said a statement from Fred Upton (R-MI), chairman of the House Energy and Commerce committee. “This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).

 

Interestingly, the issue of drug compounding seems to have superseded that of track-and-trace legislation in the discussions. The Senate bill put forward earlier this year included regulation of compounding; the House bill did not. Given that track-and-trace legislation has been debated and wrestled with since around 2006, while the compounding topic only appeared within the past year, there was a risk that the ongoing legislative efforts for track and trace could have been derailed by the compounding issue.

Continue to read here

 

 

FDA Law Blog - HHS Issues Refill Reminders Guidance Ahead of Compliance Deadline; FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions

By Jeffrey N. Wasserstein & Alexander J. Varond –

Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance  entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.”  In prior posts, we discussed the HITECH final rulehere, here, and here.  The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs:  (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial

Here is another viewpoint on compounded hormones and why women turn to them

http://www.breastcancerchoices.org/files/Bioidentical-hormone-debate.pdf

New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

Drugmakers would get more FDA scrutiny under draft bill By Steve Walsh, Bloomberg News

The U.S. for the first time would have uniform regulations to help identify stolen or fake drugs, and makers would get more scrutiny, under a draft bill from the Senate and House committees that oversee pharmaceutical safety. 

The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution. 

The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement. 

"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution." 

Counterfeit Imports 

The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences. 

Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history. 

The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections. 

FDA Criticized 

The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified. 

The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959. 

Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines. 

A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs. 

Documented Deaths 
continue to read   here

Drug compounding compromise reached, Lamar Alexander says House, Senate work out bill, but FDA may not support it Sep. 26, 2013 5:18 AM

A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.

The compromise was disclosed late Wednesday in news releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders, including U.S. Rep. Henry Waxman, a California Democrat.

The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health care providers in 20 states.

Industry officials said the compromise had been worked out over the weekend, but they expressed concerns the FDA had last-minute objections.

Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.

continue to read here

KUDOS to Texas State Board of Pharmacy (TSBP) for Proposed Rules Relating to Compounding; TSBP Final Report dated August 6, 2013, of Task Force on Preparing Sterile Prepartions

http://www.tsbp.state.tx.us/files_pdf/BN/Aug13/Tab_15.pdf

Great Law Review Article by Paul C. Kuhnel entitled Pharmacists and the People Who Sue Them (note article was published in 2007 and some areas such as HIPPA has changed since it was written)

read here