Wednesday, January 30, 2013

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing


source found here

Tuesday, January 29, 2013

Virginia Bill 2312 Dealing With Compounding Introduced

On January 18, 2013,  VA Bill 2312, was introduced into legislation.  This bill includes new definitions and regulation of compounding. The bill would permit the Virginia Board of Pharmacy to revoke or suspend a pharmacy permit if the Board believes the actions of the pharmacy are of imminent threat to the citizens of the state. Language also is proposed that provides additional explanation to anticipatory compounding and defines compounding activities in "inordinate quantities" over anticipated patterns of prescribing and dispensing as manufacturing.

To view this bill click here

Oklahoma State Board of Pharmacy Inspections Stats


From information provided by Cindy Hamilton, D. Ph. Chief Compliance Officer for the Oklahoma State Board of Pharmacy, the Oklahoma Board of Pharmacy conducted 1173 inspections in 2011 and 1155 inspections in 2012.  Oklahoma has 1142 pharmacies and 400 facilities located in the State of Oklahoma.  These inspections include pharmacies and facilities (medical gas suppliers, wholesalers, manufacturers, etc.)  The Oklahoma Pharmacy Board  attempts  to inspect each registrant once a year unannounced.   However, for the past two years the Oklahoma Pharmacy Board has  been short a compliance officer. The board does not keep individual statistics on the number of compounding pharmacies inspected.

Virginia Board of Pharmacy Ad Hoc Committee to Meet Regarding Documentation Submitted from Registered Nonresident Pharmacies in Response to Recent Compounding Survey

Meeting to Be held on February 1, 2013, at 9:00 a.m.  To view agenda and for location click here

Michigan Introduces Bill Dealing With Pharmacies


SENATE BILL No. 92



January 29, 2013, Introduced by Senators GREEN, JONES, PROOS and HANSEN and referred to the Committee on Health Policy

  A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 16333, 17705, 17707, 17711, 17721, and 17731

(MCL 333.16333, 333.17705, 333.17707, 333.17711, 333.17721, and

333.17731), section 16333 as added by 1993 PA 80, section 17705

as amended by 1986 PA 304, section 17707 as amended by 1990 PA

333, sections 17711 and 17721 as amended by 2006 PA 390, and

section 17731 as amended by 1994 PA 234, and by adding sections

17735, 17736, and 17744a.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 1        Sec. 16333. Fees for a person licensed or seeking licensure

 2  to engage in the practice of pharmacy or other practices

 3  regulated under part 177 are as follows:

College of Veterinary Medicine to host 50th annual conference, alumni weekend | UGA Today

College of Veterinary Medicine to host 50th annual conference, alumni weekend | UGA Today

Dr. Lynn White-Shim of the American Veterinary Medical Association will present the two-hour Georgia laws, ethics and professionalism session on "Compounding: Are You Following the Rules?" for continuing education credit. For those interested in this session only, registration is $40.

Meningitis outbreak just ‘tip of the iceberg,’ ex-fed testifies

January 25, 2013

A former FDA regulator turned compounding pharmacy watchdog told state lawmakers the loosely regulated industry has gone unchecked for too long and warned the deadly nationwide fungal meningitis outbreak linked to Framingham-based New England Compounding Center just scrapes the surface of problems linked to the industry.
“This is one we know about,” Dr. Sarah Sellers told the Herald after her hourlong testimony on Beacon Hill yesterday. “What we don’t know about is even more concerning because most drug-related problems are very difficult to detect, so we’re only getting the tip of the iceberg.”
Sellers alleged the industry operates with huge profit margins but under far less regulation than big pharmaceutical companies.
 
But the industry fired back, saying regulators need to enforce rules already on the books and that major incidents at compounding pharmacies are rare.
“There is no indication that this is an industry that’s out of control,” said Todd Brown of the Massachusetts Independent Pharmacists Association. “This whole thing would have been prevented if the FDA had done their job, enforced their regulations and if the Board of Pharmacy had enforced their regulations.”
A top state health official told the Herald things are changing post-NECC.
“This tragedy has been a wake-up call to all different sectors of that industry and the regulatory arena as well,” said Madeleine Biondolillo of the Bureau of Health Care Safety and Quality. “We’re very confident that between the work we’ve done to inspect the industry and get a lot more information than was ever provided before, we’re going to be increasingly effective.”
State Sen. Mark Montigny (D-New Bedford), who accused the industry of exploiting a lack of regulation it helped create through intense lobbying, said he thinks the aftermath of NECC will make it easier for lawmakers to tighten the rules.
“They’ve already lost the opportunity for constructive feedback,” Montigny said.
 
Source found here
 
 

Testimony in MA that NECC was an accident waiting to happen and the compounding industry is rife with potential conflicts of interest


Montigny misses mark
January 28, 2013
Sen. Mark Montigny (D-New Bedford), who often targets Big Pharma and its lobbying efforts in his perpetual search for bad guys, may have actually found a better target in Little Pharma — those compounding pharmacies that have grown and grown and yet remained under the radar screen.
That is until 44 people died and 678 were sickened by fungal meningitis traced to the New England Compounding Center, which went virtually unregulated and uninspected until it was too late.
So last week Montigny chaired a meeting of the Senate Post Audit and Oversight Committee at which Dr. Sarah Sellers, a former compounding pharmacist and former Food and Drug Administration official testified that the NECC case was “an accident waiting to happen” and that the compounding industry is rife with potential conflicts of interest.
Montigny, of course, chose not to focus on the obvious — that the state Board of Registration in Pharmacy was itself rife with such conflicts and failed in its responsibility to regulate compounding pharmacies here. No, he chose to zero in on his favorite bete noir:
“When we allow special interests to ply their trade so successfully in Washington and in state capitols, the outcome is inevitable, and in this case deadly,” he insisted.
Yes it’s all about the lobbyists — really!
How about public officials who weren’t doing their jobs? How about greedy owners who even as people were dying and NECC was in bankruptcy proceedings were looting its treasury, according to their bankruptcy court filings?
It’s all shameful, but as usual the senator misses the point.

Source found here

American Society of Pharmacy Law Track and Annual Business Meeting: Mark the Date


ASPL Pharmacy Law Track and Annual Business Meeting

American Society for Pharmacy Law Track
ASPL will once again be sponsoring a series of sessions on Pharmacy Law at APhA 2013 in Los Angeles, CA March 1-4.  For more information about the APhA 2013 annual meeting, go to www.aphameeting.org.

Pharmacy Law Track:
  • Case Law Update
  • Legislative & Regulatory Update
  • Hot Law Topics
  • Warning: What You Don't Know Can Hurt You — Understanding the Consequences of State Board of Pharmacy Actions
  • FDA Update
  • HIPAA and HITECH: New Requirements for Privacy and Security
  • Mitigating Your Legal Risk: Challenges to Compliance in the Current Regulatory Framework
  • Pharmacy Social Media Boot Camp: Legal Issues

ASPL Annual Business Meeting
Please join us for the Annual Business Meeting and Reception to be held on Saturday, March 2, 2013, at 6:00 pm at the JW Marriott Hotel.

Florida State Surgeon General Tours Compounding Pharmacy


Contact: DOH Communications
(850) 245- 4111
STATE SURGEON GENERAL TOURS COMPOUNDING PHARMACY IN PENSACOLA
~Representative Clay Ingram tours Pensacola Apothecary with Dr. Armstrong~
TALLAHASSEE- Florida Surgeon General and Secretary of Health Dr. John Armstrong was recently joined by Representative Clay Ingram, R-Pensacola, in a tour of Pensacola Apothecary, a compounding pharmacy in Pensacola, Fla. The local pharmacy provides services to Northwest Florida physicians and specializes in formulating and customizing medications to meet the special health needs of patients and to assist where certain medications are not available. With recent discussions regarding compounding practices in the state and across the nation, this tour presented a unique opportunity to gain first-hand knowledge of the practice and to work with the Board of Pharmacy in its ongoing discussions of changes to best protect all Floridians.
“Pensacola Apothecary serves as an industry standard for quality of service and safe practices,” said Dr. Armstrong. “These strict quality standards should be the benchmark for all compounding pharmacies so that patients in Florida receive safe compounded medications.”
Supervising pharmacist Christopher Schulte manages Pensacola Apothecary, a community and special parenteral and enteral pharmacy. A parenteral and enteral pharmacy is licensed to compound sterile medications such as intravenous “IV” therapy and nutrition, irrigation solutions, feeding tubes and other sterile products such as eye drops. Pensacola Apothecary opened its doors in 2003 and is Northwest Florida’s only Pharmacy Compounding Accreditation Board (PCAB) accredited pharmacy, the highest quality and safety standards in the profession.
“Pensacola is fortunate to be served by one of the state’s leaders in safe, high-quality compounding,” said Rep. Clay Ingram. “I personally saw the extraordinary measures taken by Pensacola Apothecary to ensure that patients are protected, and that kind of commitment to safety sets a wonderful example for other compounding pharmacies in Florida.”
National conversations have emerged regarding the safety of compounded medications as the result of the fungal meningitis caused by contaminated injectable products compounded at the New England Compounding Center in Framingham, Mass. The Florida Department of Health, along with the Florida Board of Pharmacy will continue to review current regulation of Florida’s pharmacies to identify measures for improvement. Results from a mandatory compounding practice survey have recently been released and will serve as a guide to future rulemaking in order to protect patients without creating unduly burdensome regulation.
DOH protects, promotes and improves the health of all people in Florida through integrated state, county and community efforts.
###

Aren't We All In This Boat Together And All Looking For the Right Solution? APhA's Position is Refreshing.

One of my favorite times to write is late at night when the house is quite.  Actually it is a habit.  While working at the U.S. Attorney's Office most nights  I had to stay up and work after everyone else at my house had gone to bed.  Deadlines come fast and furious in the federal government's legal world.  Long hours are the norm.   Attorneys do their best not to miss deadlines for a number of reasons--there are the ethical reasons--sanctions from the court, causing your side to lose, etc.  As AUSA(Assistant United States Attorneys)  there was another reason.  When you are sworn in as an AUSA you take an oath of office--this is after all the background checks and security clearances-deeming you worthy of these positions.  The oath is a pledge that you will represent and defend the United States of America.  Most AUSAs, if not all,  take this oath extremely serious.  After all isn't it extremely serious to represent and defend  one's country.   Does that, however, make one pro-government?  I suppose that depends on what one means by the use of the word pro-government?  Does pro-government always mean that you believe in more, bigger government?  No. It does not.  Pro-government can also mean you believe in your government--the United States of America-and that you will represent and defend it as necessary.
At times as an AUSA you might be asked to defend a law that you personally did not believe in.  That was the job you were paid to do. A lot of times you are required to advocate a position that is not your personal belief, but again that is what you are required to do even when you thought it made you look disingenuous.

Likewise, does anti-government mean you hate government of any kind?  Does it mean you prefer state government over the federal government to regulate certain areas?  Does it mean government can be big as long as it is state government doing the regulating and not the federal government?  Again, I think different people have different ideas of what these terms mean.  I know I have been labeled by some as pro-government because I spent a great part of my legal career representing the United States of America and defending the Constitution and the rights it provides.  I took my job very, very seriously as an AUSA, and I tried to honor the oath I swore to,  I also represented the great state of Oklahoma as an Assistant Attorney General and took an oath there also.  People don't seem to focus on that job.  Does that job make me pro-state government?  How do you mesh the two and come up with the right label for me if you are simply basing it on where I worked and nothing else?  Is it really fair to label me at all simply because I have a background in federal and state jurisdiction and understand the legal ins and outs and some of the legal challenges of both?

There are both sound arguments for and against the FDA taking over all or a bigger part of regulating compounding.  Similarly, there are sound arguments for and against the states continuing to regulate compounding.  APhA's position announced on the blog earlier today was refreshing.  It was refreshing to see thatAPhA's is considering options even though it involves change. It is refreshing that APhA wishes to continue the dialogue with the FDA and work to find the best solution.

The point of this blog is and always has been to educate, inform and open up the dialogue regarding issues in the compounding world.  Is this blog meant to be negative toward compounding? Absolutely not, but it is meant to present multiple sides and views.  The recent events of NECC have caused a negative spin on compounding. That may be unfortunate, but it is the reality. On a recent post when I asked readers to comment on the positive of compounding, I got no responses despite the post being well read.  I still welcome any and all positive stories that readers want to share about compounding.
I hope that others will be open to new ideas and solutions to make the compounding world a better safer place no matter who ultimately is in charge of regulating it.

Repost: APHA's page Explaining necessity of compounding and how all compounding is subject to both state and federal regulations already


Frequently Asked Questions About Pharmaceutical Compounding


Last Updated: November 19, 2012
What is pharmaceutical compounding and why is it necessary?
Compounding is the creation of a pharmaceutical  preparation – a drug – by a licensed pharmacist to meet the unique needs of an individual patient when commercially available drugs do not meet those needs. A patient may not be able to take the commercially available drug, or a patient may require a drug that is currently in shortage or discontinued.
These are a few examples of the ways a compounding pharmacist can customize medications with a doctor’s prescription to meet a patient’s needs:
  • Adjust strength or dosage.
  • Flavor a medication, for example to make it more palatable for a child.
  • Reformulate the drug to exclude an unwanted, nonessential ingredient, such as gluten or a dye that a patient is allergic to.
  • Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.
Compounding pharmacists can put drugs into specially flavored liquids, topical creams, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not replicate commercially available drug products.
How is pharmaceutical compounding different from drug manufacturing?
Compounding is the preparation of an individual drug to meet the prescriber’s exact specifications and to be dispensed directly to the patient or the prescriber. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see below question on legal oversight of compounding versus manufacturing). Compounded drugs are not for resale by the patient or prescriber.
Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care practitioners or others authorized under state and federal law to resell them.
What is a compounding pharmacy?
While all pharmacies do some types of compounding, this is more common or the primary focus of a small portion of American pharmacies. The preparations  offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for injection into body tissues or the blood).
All licensed pharmacists learn during their four years of pharmacy school to perform basic compounding. In addition, all pharmacies have compounding tools such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, scales for weighing solids, spatulas for mixing materials, and pill tiles on which to work. With such tools and applying their knowledge, all pharmacists routinely prepare nonsterile compounded products when requested by physicians.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations  for patients. Preparations in these pharmacies are more likely to be both sterile and nonsterile. Compounding also takes place in hospital pharmacies and at other health care facilities.
Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not?
All pharmacists and pharmacies involved in compounding are subject to oversight by both federal and state authorities.
The practice of compounding is regulated by state boards of pharmacy. Pharmacists engaged in compounding are expected to follow appropriate procedures for the types of preparations that are compounded.
FDA has oversight for the integrity of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations.
The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines and similar drugs, and drugs such as those used for anxiety and sleep disorders.
In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This quasigovernmental organization defines the chemical composition of drugs and also issues practice standards. Two standards in particular are relevant to compounding pharmacists.

Continue reading here

FDA works with pharmacy, states on compounding; NOT On Mission to Stop Compounding Per APHA


By now, we’re all aware of the terrible tragedy and 39 deaths that resulted when unfortunate and unsuspecting patients were injected with products inappropriately manufactured by a pharmacy in Massachusetts that called itself a compounding pharmacy.
Yesterday FDA held a closed intergovernmental meeting on a Framework for Pharmacy Compounding: State and Federal Roles for representatives from all 50 states as well as FDA staff—more than 100 people in all.
The last 2 hours of the meeting were public. In opening remarks, FDA Commissioner Margaret A. Hamburg, MD, noted that the agency had spoken with more than 50 different organizations, including pharmacy groups, leading up to the meeting. “Today was the states’ turn,” Hamburg said, to discuss four questions that get to the heart of federal and state roles. What FDA heard underscores the need for new legislation, she added.
During the public discussion of the questions, state representatives zeroed in on the need for clear definitions of pharmacy compounding versus manufacturing, and better communication among states and between FDA and states. Cody Wiberg, PharmD, MS, Executive Director of the Minnesota Board of Pharmacy, said at the meeting that most states have the authority and resources to handle traditional compounding, but fewer states may have the resources to handle nontraditional compounding in facilities like the New England Compounding Center (NECC). “I think the consensus in our group was in the latter case, with NECC, there is a role for the FDA to be involved,” Wiberg said.
Hamburg responded minutes later that the issue about defining the terms—compounder, manufacturer—and how that then aligns with regulatory actions is “just so, so fundamental.” She suggested a working group to address the issue.
Another takeaway from the meeting was the National Association of Boards of Pharmacy’s work with the Iowa Board of Pharmacy to start investigating out-of-state pharmacies, leading in turn to the creation of a database for all boards of pharmacy that will track the licenses and disciplinary measures taken against pharmacies nationwide. 
FDA’s meeting with states followed a separate meeting with FDA that I attended on December 14 with about a dozen other national pharmacy organizations and stakeholders. We discussed the agency’s interest, among other things, in a clear distinction between manufacturing and compounding that could allow state and federal regulators to better protect the public.
Representing APhA, I shared the perspective that pharmacy is committed to doing everything possible to enhance patient safety while maintaining access to our compounding services. We promoted greater recognition of Pharmacy Compounding Accreditation Board standards and offered some suggestions on ways to help differentiate compounding from manufacturing.
FDA is not on a mission to stop compounding, as may have been the perception in prior years. Rather, they are looking for ways to better define manufacturing, which they see as their responsibility to regulate and to enforce maintenance of good practices. We appreciated FDA’s recognition of the value of compounding and did not observe any interest on their part in hindering that practice. Their goal is to better regulate manufacturing in order to protect the public.
This discussion is just beginning, but based on FDA’s posture on the 14th, we’ll be at the table throughout the debate.
More to follow on this. Meanwhile, you are encouraged to comment on the agency’s four questions—outlined in the November 28 Federal Register notice for the FDA meeting with states—due January 18, 2013. And remember, APhA continues to post compounding updates and resources on pharmacist.com at Just the Facts: Compounding
Source found here--APHA website.

BREAKING NEWS: APHA Supports FDA's Proposed Regulatory Framework For Pharmacy Compounding


APhA believes that this tiered regulatory approach “has its merits, generally supports the concept, and is very interested in continuing dialogue with FDA, Congress, States and other stakeholders to explore potential solutions,” according to its January 18, 2013, comment letter to FDA.
The Association recommended considering the following areas for further clarifications and additions:
  • Compounding standards: APhA supports efforts to ensure proper resources and funding for state boards of pharmacy for compounding regulatory activity.
  • Sterile compounding licensure: APhA supports consideration of enhanced standards and state licensure for sterile compounding to ensure consistent standards across all states and providers in all practice settings.
  • Manufacturer versus compounder: APhA agrees with ongoing dialogue that the definition of compounding versus manufacturing needs to be clearly defined.
  • Amount/quantity
  • Compliance policy guide
  • Education and training resources
  • Communication
  • Accreditation
The Association’s January 18 letter to FDA built on the December 2012 intergovernmental meeting; APhA’s discussions with FDA at the December 2012 pharmacy stakeholders listening session; APhA’s comments to the Senate Health, Education, Labor, and Pension Committee in November 2012; meetings with House Energy & Commerce Committee staff; and APhA’s ongoing dialogue with congressional and agency staff, the pharmacy community, and other stakeholders.

Inspection at Taiwan plant illustrates FDA inspections challenge Facility failed to do in-process testing or keep raw data to validate safety Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JObx7USd Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing


With countries all over the world building up their drugmaking capabilities, the FDA is working to keep up with inspections of existing plants even as more come online. In fact, the FDA says there are now more foreign than U.S. plants that it must keep tabs on. When FDA inspectors do get in them, they often find that facilities that have been exporting products to the U.S. for years are not meeting some of the most basic manufacturing standards.
A warning letter posted today on the FDA website for a operation in Taichung City, Taiwan, illustrates the challenge. Inspectors found that the Beanne Chemical facility failed to validate its manufacturing processes; was not conducting in-process testing, only finished-product testing; and was not testing for stability that would support expiration dates.


Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JOc53KAG
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Compounder that operated like drug plant paid big bucks to owners



Judge orders NECC shareholders to keep hands off $21 million in payments


Read more: Compounder that operated like drug plant paid big bucks to owners - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/compounder-operated-drug-plant-paid-big-bucks-owners/2013-01-29#ixzz2JOb2bfSn
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Bill would ban basic compounds behind synthetic drugs like bath salts, spice


About HB 2327:
• Author: Rep. Eddie Farnsworth, R-Gilbert.
• Key provision: Would expand the state's definition of dangerous drugs to include chemical configurations that typically compose synthetic cannabinoids and bath salts.
• Status: Endorsed by the House Judiciary Committee and headed to the floor by way of the Rules Committee.
PHOENIX – It’s become a pattern as state lawmakers try to address synthetic drugs such as bath salts or spice: Almost as soon as one recipe is outlawed, manufacturers simply change to a mix that isn’t banned.
Hoping to get ahead of that cycle, the chairman of the House Judiciary Committee is out to ban the basic chemical formulas underlying such drugs.
“Imagine a Christmas tree. You can change one of the bulbs on the lights and it’s a little different, but it’s the same tree,” said Rep. Eddie Farnsworth, R-Gilbert. “This bill would just outlaw the Christmas tree.”
Farnsworth said that chemists have identified the most basic formulas used to create synthetic drugs. HB 2327 would ban those basic formulas so the substances are always illegal despite any alteration.
He said he avoided banning any formula that had a legitimate commercial use, such as the recipes for cleaning supplies.
Continue to read here