IV Solution Shortages

Important Information Regarding IV Solution Shortages:

March 13, 2014
An Open Letter to All McGuff Customers

RE: IV Solution Shortage Approaches Critical Situation

Dear Valued Customer,

As you may be aware, there is a critical shortage of IV solutions in the United States. There are three manufacturers in the United States; Hospira, Baxter and B Braun – all of which are not able to manufacture enough IV solutions to meet national demand. All three manufacturers have sent letters to wholesalers, physicians and clinics indicating their IV solution purchases will be restricted or stopped. This became known as an Allocation Program. The Allocation Program for B Braun IV solutions started almost 15 months ago. During this time, all of us at McGuff have worked very hard to make sure the Allocation Program of IV solutions did not have a detrimental effect on our customers.

McGuff has been managing the shortage by declining to add new customers that Hospira, Baxter and B Braun have cut off. In addition, we are careful to review each customer order and history of purchases to assure no single customer can order too much of these scarce resources. We have also used our best abilities to control our inventory, our purchases, and have utilized other means to minimize the impact of the shortage to our current and loyal customer base.

In late January 2014 B Braun informed us that our allocation (the number of IV solution cases we can purchase) would again be reduced because of the deepening, national shortage of IV solutions. This new allocation is designed to stop McGuff from delivering IV solution products to "non-contract customers". B Braun designates "non-contract customers" as any customer who purchases only IV solutions and does not purchase B Braun medical devices such as IV sets, catheters, extension sets, etc.

Upon this notification and to protect our customers, McGuff immediately contacted the B Braun designated "non-contract customers" to explain that they were at risk of having their supply of IV solutions cut off by the manufacturer. We were very successful in converting most customers to the B Braun IV sets and catheters. Based on B Braun statements, we believed customers that converted to B Braun IV sets and catheters would not be cut off.

We just have received another B Braun letter dated February 28, 2014 (attached) that indicates our allocation will be further reduced as B Braun will not provide IV solutions to McGuff to support "non-contract customers". We were shocked that the list of “non-contract customers” attached to the letter represented about 55% of all our IV solution customers.

The good news!

This is a very difficult time. Because of the additional restrictions, we may not be able to provide you with manufactured IV solutions for each order. Our inventory of IV manufactured IV solutions is volatile and we can not depend on the word of manufacturers to tell us when or if they will deliver new replenishment shipments to us. However, McGuff is in a unique position to help you with our compounding pharmacy.

Most compounding pharmacies that compound injections purchase sterile water for injection in bottles or bags from IV solution manufacturers. These pharmacies are subject to the same IV solution shortages that hospitals, clinics, physicians and patients are experiencing.

McGuff Compounding Pharmacy Services, Inc. is not dependent upon commercially manufactured sterile water for injection. We utilize Water for Injection, USP produced by McGuff Pharmaceuticals (an FDA registered drug establishment) as a bulk drug substance. This relationship will allow McGuff pharmacy to continue to produce injections and IV solutions without disruption during this national shortage.

McGuff Compounding Pharmacy is responding to this shortage by initiating preliminary design review and quality assessments to produce 0.9% Sodium Chloride in 250mL and 500mL bags. It is anticipated 0.9% Sodium Chloride IV solution bags will be available by prescription during the first week of April, 2014. The pharmacy also intends to produce Sterile Water for Injection in 250mL and 500mL IV solution bags as necessary.²

What does this mean to you? You now have an alternative source of quality IV solutions if McGuff Company can not provide you with IV solutions from Hospira, Baxter or B Braun. We are very proud that we are able to do this for you, as needed.

Please remember, our priority is to always provide you with manufactured IV solutions when they are available.

The IV solutions from the pharmacy will be in sterile plastic bags made by Hospira. However, these IV solutions will come with a more complicated ordering routine and extra cost. For full disclosure the IV solutions from the pharmacy will:

• Require a prescription for an identified patient
• Cost approximately $15.00 per bag plus freight
• Typically have an expiration date of no more than 30 days
• Be refrigerated upon receipt
• Not be available for returns or credit

Again, our priority is to always provide you with manufactured IV solutions when the inventory is available. Prior to purchase, you or your purchasing agent will always know if you will receive manufactured or compounded IV solutions.

We appreciate your understanding that the McGuff Company has not created the national shortage of IV solutions. We are, however, in the very difficult, delicate and expensive position of minimizing the impact of this very unusual situation to all customers.

Please let us know if you have any questions or if we may be of additional service.

Very best wishes,

The McGuff Company

¹ B Braun has indicated 70,000 letters have been sent to customers who purchase B Braun products.

² Pharmacy management, exhibiting extra caution, has decided not to compound Dextrose 5% in Water IV solutions (D5W). Compounded D5W bags may contain components that, over time, could be conducive to microbial growth. If D5W is in short supply, the pharmacy will provide Sterile Water for Injection in 250mL or 500mL bags. A physician can mix the Sterile Water Injection with an appropriate dextrose solute to produce a D5W IV solution.

March 7, 2014
McGuff Company, Inc.

IV Solution Shortage and McGuff’s Allocation from B Braun

McGuff Compounding Pharmacy Services, Inc. is responding to the national shortage of IV solutions

A February 12, 2014 article in Drug Topics quoted a survey by the American Society of Health-System Pharmacists that is titled “Saline shortages affecting 3 out of 4 hospitals”. The FDA also acknowledges the shortage of Sodium Chloride 0.9% Injection Bags on their Current Drug Shortages Index. Unfortunately, the national shortage is also affecting customers of the McGuff Company.

As you may know B Braun, on February 4th announced that the allocation of IV Solutions to McGuff Company would be reduced by 50% on March 1, 2014. We have been notified today that the allocation reduction will start April 1, 2014.

We all have one extra month!

The McGuff Companies are dedicated to providing our customers with the highest quality products at the lowest possible prices. McGuff Company will always try to provide a manufactured product if available, as it is the best value to our customers.

Unfortunately, the ongoing unstable commercial injectable supply in the U.S. is causing random backorders of your preferred injectable products. When a commercial product is backordered, McGuff Company may refer customers to McGuff Compounding Pharmacy Services, Inc. as the compounding pharmacy may produce similar products during a manufacturer's backorder.

As an example, Magnesium Sulfate Injection has been in short supply since early this year, and the situation isn’t expected to be resolved soon. When McGuff Company has the commercial product, we will offer it to our customers until stocks run out, as this will save you money and provide you with an FDA approved product. When the commercial product is not available, McGuff Compounding Pharmacy will offer compounded Magnesium Sulfate Injection.

McGuff is in a unique position to work with suppliers, compounding pharmacy and customers to assure continued supply of drugs that are in short supply without interruption to our customers.

Working together we can make it through this time of injectable shortages.

View a list of Drug Shortages & Product Availability for Our Commonly Ordered Products