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Roadrunner ExpressRoadrunner Pharmacy 711 E. Carefree Hwy. Suite 140, Phoenix, AZ 85085 Summer 2015

www.roadrunnerpharmacy.com

877-518-4589

Veterinary practitioners have long looked to Roadrunner Pharmacy as the leader in animal health compounding and innovation and we haven’t disappointed. With the increased scrutiny of sterile compounding and the inherently high costs associated with it, many compounders have made the decision to discontinue making sterile products. Instead of downsizing, we’ve spent the spring upgrading and expanding our sterile suites to ensure compounding of the highest quality products and to broaden our selection, especially in the ophthalmic area. (continued on page 3)

Is the FDA AttemptIng to RegulAte VeteRInARy CompounDIng WIthout CongRessIonAl AuthoRIty?

eXpAnsIonCOMPLETE!

In May, the FDA released for public comment a draft guidance document entitled “Compounding Animal Drugs from Bulk Substances”. This guidance will supercede the 2003 CPG that has since been withdrawn. The 2003 CPG allowed for compounding from bulk powders for your child but prohibited it for your pet! This document suggests new guidelines for compounding pharmacists AND veterinarians. These are mandates not supported by existing federal law or congressional intent AND contradict long-standing state authority to govern veterinary medicine. We have included a summary page with this newsletter from the International Academy of Compounding Pharmacists for your review. They and others have requested an extension in the deadline for public comment. (continued on page 4)

2 Friendly pharmacists are standing by! 877-518-4589

steRIle ophthAlmIC tReAtments

Compounded Ophthalmic OintmentsChloramphenicol 1% - (Releasing Soon)Idoxuridine 0.1% - (Releasing Soon)Oxypol 0.5% *PNB Fortified - (Releasing Soon)PNB Fortified + HC - (Releasing Soon) Tacrolimus 0.02%

Compounded Ophthalmic SolutionsCidofovir 0.5%Cyclosporine 2% **Demecarium Bromide 0.125%Demecarium Bromide 0.25%Gentamicin 3/Betamethasone 1mg/mlIdoxuridine 0.1%Tacrolimus 0.02% in Corn oilTacroliteTM 0.02% in Mineral oilTacrolimus 0.03% in Corn oilVoriconazole 1%

Compounded Ophthalmic Suspensions Itraconazole 1%Prednisolone acetate 1.25%

TacroliteTM Solution & Tacrolimus Ointment This is our most commonly requested sterile ophthalmic medication and is available in multiple formats.The first is in mineral oil at a concentration of 0.02% in either metered-drop tubes or bottles. It is also available as a drop in corn oil at either 0.02% or 0.03% in bottles.

Back by popular demand… Tacrolimus ointment! This sterile ointment is available at a concentration of 0.02% and is a great option for veterinarians treating KCS and dry eye, just like all other forms of Tacrolimus.

CidofaDropsTM

CidofadropsTM, a new name and package for our Cidofovir 0.5% ophthalmic clear solution, is gaining popularity as veterinarians’ first choice in Feline Ocular Herpes.

CIDOFADROPS OXYPOL

TACROLITETM DROPPER TUBE

TACROLIMUS CORN OILTACROLITETM MINERAL OIL

TACROLIMUS OINTMENT

The majority of these products will be compounded with 6 month Beyond Use Dating (BUD)

** Cyclosporine is compounded in a synthetic version of the major component of coconut oil.

3The information contained is intended for use as an informational aid. It does not cover all possible uses, actions, precautions, side effects, or interactions of the preparations shown, nor is the information intended as medical advice or diagnosis for individual health problems or for making an evaluation as to the risks and benefits of using a particular preparation.

Information and statements have not been evaluated by the Food and Drug Administration (FDA), nor has the FDA approved the preparations to diagnose, cure or prevent disease. Roadrunner Pharmacy compounded veterinary preparations are medications prepared at the direction of a veterinarian and are not intended for use in food and food-producing animals.

(continued from page 1)We have DOUBLED the number of ISO 7 cleanrooms and ISO 5 work stations, allowing us to increase our offerings, to include Tacrolimus 0.02% ophthalmic ointment, Oxypol 0.5% ophthalmic ointment and Cyclosporine 2% ophthalmic solution, just to name a few.

These rooms must adhere to specifications found in USP 797. Our sterile processes and facility are inspected annually by numerous state inspectors as well as the National Association of Boards of Pharmacy.

Sterilizing ophthalmic ointments is a huge and complex undertaking. Unlike injectables that can be filtered or autoclaved, neither process can be utilized with finished ophthalmic ointments. Just like injectables, they must be quarantined and tested for sterility prior to dispensing.

In another industry leading move, Roadrunner Pharmacy has acquired a state-of-the-art vial washer dedicated to the decontamination of injectable vials to improve the sterile process.

For as long as there has been a Roadrunner Pharmacy, patient safety has been JOB ONE. This expansion project will greatly enhance our ability to provide you and your patients with the highest quality sterile products.

To learn more about our sterile process, watch our brief video ”Commitment to Sterile Compounding” on our website at:www.roadrunnerpharmacy.com/vets/videos/

CyclosporineYES! WE HAVE IT! Available as a 2% sterile ophthalmic solution, this medication is used by veterinarians as an alternative adjunct to Tacrolimus.

VoriconazoleThis sterile ophthalmic solution is available in a 1% concentration and is frequently requested for use in fungal infections.

VORICONAZOLE

CYCLOSPORINE

OxypolThis sterile anti-biotic ointment is a combination of Oxytetracycline and Polymyxin. * Compounded based on TerramycinTM availability.

Prednisolone AcetateThis ophthalmic steroid is available as a sterile 1.25% suspension. This medication is often prescribed to aide in the treatment of inflammation due to allergy or trauma.

PREDNISOLONE ACETATE

eXpAnsIon

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Insert with EVERY medication shipped

to pet owners!!Sincerely, Rob & Sabrina Eaton Owners, Roadrunner Pharmacy

www.RoadrunnerPharmacy.com | 877-518-4589

At Roadrunner Pharmacy, we make every effort to ensure that your order meets the highest of standards and that your experience is what you would expect from us. Thank you for the opportunity to compound your pet’s custom medication needs. We fully support you and your veterinarian and are blessed to have customers like you.

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Did you know?

FDA ContInueD(continued from page 1)In this draft guidance, it is clear the FDA wants to apply the same regulations designed for human compounders to veterinary compounders. Additionally, they would require veterinarians to include very specific and lengthy wording on each prescription, limit anticipatory compounding to 14 days and severely control the use of properly tested bulk powders.

Relative to veterinary medicine, we find the FDA’s suggestion to create a ‘Never To Be Compounded’ list to be preposterous. Any therapeutic agent may need to be compounded at some point—yes, even in the absence of evidence-based studies.

Roadrunner Pharmacy has ALWAYS proposed an exclusion for veterinary compounding – the scope of practice for each practitioner is vastly different. A recent study commissioned by Roadrunner Pharmacy illustrated overwhelming support from veterinarians for compounding, especially in this era of back-orders, hard-to-find and discontinued items, that involves the use of bulk powders. Properly tested bulk powders allow compounders the ability to have precise control over the final drug – exact concentrations and no unwanted excipients.

As ALWAYS, Roadrunner Pharmacy will continue to work closely with state and national veterinary organizations to ensure your needs are being considered in future regulations.

You can also download the International Academy of Compounding Pharmacists summary here: http://goo.gl/ef6cXR

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sponsored Dinner Talk, please contact Stephen Bishop at:

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