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

FDA GUIDANCE Guidance for industry-compoundinG!

877-518-4589

As we have addressed in this forum, the FDA is proposing “Guidance for Industry-Compounding Animal Drugs from Bulk Drug Substances.” This guidance is remarkable in its restrictions and impact to the veterinary community such as:

•Documentingclinicalneedoneachprescriptionforcompoundeddrugs •Noofficestockofcompoundedmedicinals,sterileorotherwise •Scriptstobepet-specific--noflocks,fishorgroupsofshelteranimals •Noallowancefordispensingofacuteamountsfromofficestock •Interferesintheprofessionaldecision-makingofvetsandpharmacistsin the use of bulk powders

Notonlydowefindtheseguidelinescontrarytothepracticeofcontemporary veterinary medicine, they are also detrimental

to pharmacies, many of whom are no longer making sterile products.

The AVMA has responded to this proposal (http://goo.gl/IFkoub) which addresses serious therapeuticdeficiencies,intensifiedrecord

keeping and discusses the need and urgency for compoundedsterileitemsforofficeuseaswell

as the need to dispense compounds for acute conditions. Also enclosed in this newsletter

is a copy of a letter to the FDA from several congressmen who oppose the FDA’s approach; they

feel the FDA has exceeded its authority and ask that the FDA proposal be withdrawn.

(Continued on page 2)

1www.roadrunnerpharmacy.com

Veterinary medicine is vastly different than human medicine. Vets must deal with numerous species, vastly diverse sizes and unusual diseases. Obviously, human pharmaceuticals rarely

meet all of their needs and industry has abandoned many veterinary products that were unprofitable,notablyinjectables.Lastly,dispensingsmallamountsofspecializedmedication is often essential to a pet’s health in the absence of readily available

variations of strength and dosage form.

In spite of these recognized shortcomings, some state boards of pharmacy are seriously considering this FDA proposal for incorporation into their own regulations through a Memorandum of Understanding. Roadrunner Pharmacy has been a partner in the

veterinary community for more than 16 years; we know how important these issues are to animal health practitioners. In the presence of an 18 page response from anorganizationthatrepresentsmorethan85,000veterinariansANDgiventheserious misgivings from members of Congress, we urge you and your board to oppose these contested FDA guidelines. Appropriately, many states have granted exclusions, affording unique and often life-saving compounds to veterinarians, both sterile and non-sterile.

You’ve been heard by the AVMA! Please sign the encosed Salmon/Schrader letter requesting that the FDA withdraw GFI #230 and mail directly to your congressman.Youmayfindyourcongressman’saddressatthiswebsite:https://www.opencongress.org. You may also direct your Congressman’s staff to reach out and contact Greg Safsten (greg.safsten@mail.house.gov)inRep.Salmon’soffice,orChris Huckleberry (huck@mail.house.gov)inRep.Schrader’soffice.

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

For years, practitioners who wanted to treat horses with phenylbutazone were limited to crushing up loads of tablets or giving scoopable powders and pastes. At the urgings of a number of veterinarians, we are now compoundingaButeBiscuit.Peppermint-flavoredandeachcontaining1 gram of phenylbutazone, this dosage form provides another option to administer this often foul-tasting drug.

Call one of our pharmacists for additional information on this unique method of dosing.

Actual size is 1.75” in diameter

FDA GUIDANCE (Continued from page 1)

BUtE BIsCUIts

**States that have restricted compounded medications for clinic use:

RoadrunnerPharmacyisdiligentlylobbyinginconjunctionwithstateVMAs, legislators, lawyers and veterinarians to remove these restrictions that prevent your ability to practice best medicine. If your state is listed, we recommend that you contact the legislators, VMA and Board of Pharmacy in your state to have your voice heard!

State Office Use?

Dispensing of compounds?

Under consideration Notes

Colorado No* No *a non-resident pharmacy may not supply office use medications

Hawaii No NoIdaho Limited* No *non-sterile compounds onlyIowa No NoKansas No NoMaine No NoMaryland No NoMassachusetts No No *Possible office

use legislation to be submitted

*State Board of Pharmacy conducting a hearing November 17th

Missouri No NoNew Mexico Limited* No Sterile compounds for

office use under consideration

*non-sterile compounds only

New York No NoOhio No* No Non-resident veterinary

compounds for clinic use under consideration

*a non-resident pharmacy may not supply office use medications

Oklahoma Limited* No *non-sterile compounds only; *patient-specific prescriptions shipped to owner only

Oregon No* No *non-resident pharmacy may not supply office use medications

South Dakota No No

(**as of this printing)

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.

Since the inception of the Drug Quality and Security Act (DQSA) of 2013, federal and state regulations regardingcompoundingmedicationshavebeeninfluxandunderalmostconstantscrutiny.JustnowinAugust, almost 2 years after this legislation was passed, have states and veterinary compounders had any clarity regarding Outsourcing Facility proposals. It is not surprising then that no two states can agree on compounding,especiallyforveterinarydrugs.Whilemoststatelawsallowforofficeusecompoundedmedications and some form of dispensing, the chart below illustrates compounding restrictions remaining in select states.

CompoUNDING REstRICtIoNs

EVERY package shipped to a pet owner includes a free

brand-new toy!

Please Join Us:

Veterinarian Dinner Talks

Call for more informationor to schedule a Dinner Talk

for your organization

877-518-4589 ext. 7513

November16th - Carlsbad, CA17th - Mission Viejo, CA18th - Murrieta, CA19th - La Mesa, CA

Plus, more to come!!

oUR FRIENDly stAFF!

Insert with EVERY medication shipped to pet owners!!

Did you know?

You know how you can ‘hear’ a smile in a phone conversation? Anyone who calls here and speaks with our Carole Fendrick has heard that smile along withhercompassionandjustalittlebitof a Minnesota accent.

Carole has been an integral part of our staff for 9 years, having moved here almost 20 years ago. Carole and her husband are owned by 2 horses and 3 dogs;sheenjoyshorsebackriding,traveland dabbles in furniture restoration.

Pet owners tell us how easy she is to talk to and how she takes the time to explain our process as well as to understand their needs. Notsurprisingly,shehas‘regulars’whocallherdirectlytoplacetheir orders. When pressed to describe her style of customer service, Carole says it’s an essential blend of listening and caring, often in the face of owner concern for their pets’ well-being. Empathetic to the end, Carole takes it all in stride, treating everyone like they are good friends—and often, after all this time, they actually are.

Caroleoftensaysthatshehasthebestjobintheworld—talkingto pet owners and clinics. She exudes personality and a genuine desire to help our customers, traits we strive for in every operator.

We would clone her if we could, but everyone here knows there is justoneCarole.

4 © 2015 Roadrunner Pharmacy all rights reserved.