Life is precious - McGuff Compounding Pharmacy Services, Inc

With your patients’ health on the line, there is no substitute for quality compounded drugs.Life is precious...

Preparation and Service Guide(877) 444-1133 | www.mcguff.com

NON-CORN ASCORBIC ACID

Injection

Quality you can count on at a great price.

Our Ascorbic Acid has been independently verified as Non-Corn.

See page 6 for details.

12921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155

www.mcguff.com

Terms, Conditions & Helpful InformationCustomer Service Hours:(877) 444-1133 7:00am - 5:30pm PST Monday - Friday

All shipments are insured at our expense and guaranteed to arrive without damage.

All regular shipments to the continental U.S. deliver in two days or less. Freight added to invoice. Hawaii, Alaska and all territories and possessions please inquire.

We accept Visa, MasterCard, American Express and Discover Cards. No surcharge added to credit card order and we never charge a credit card until we ship.

Call us to set up an account. We will take care of it fast.

Due to the federal and state storage requirements of compounded preparations, we are unable to accept returns of patient prescriptions.

No minimum order. For all orders totaling less than $40.00, a $10.00 minimum order charge will be added to the invoice. Although we try to avoid it, prices are subject to change without notice.

McGuff Compounding Pharmacy Services Inc. maintains product liability insurance. You may obtain a Certificate of Liability Insurance by calling 1-877-444-1133.

© Copyright 2013 McGuff Company, Inc. - All rights reserved.

Address: 2921 West MacArthur Boulevard, Suite 142Santa Ana, California 92704

PHARMACYCOMPOUNDINGACCREDITATION

BOARD

Table of Contents

1 Terms Conditions & Helpful Information

2 Services We Provide & How Compounded Preparations May Benefit Your Patients

3 McGuff is the Best Choice for Your Compounding Needs

4 A Sampling of Supported Therapies

5 Hormone Replacement Therapy

6 Compounded Preparations - Injectable Medications

9 Compounded Preparations - Oral Medications

10 Compounded Preparations - Topical Medications

11 Compounded Preparations - Inhalation, Sublingual Medications, Suppositories

12 Laboratory Testing of Compounded Preparations

13 McGuff Pharmacy Vial Information

14 McGuff Clinical Trial Services

17 McGuff is Recognized by Peers as a Leader

18 Photo Gallery: Images of Our Pharmacy

20 McGuff Pharmacists’ Profiles

25 Compounded Preparations: Disclosure Between Parties

26 McGuff Meets National & International Quality Standards

Quality you can count on at a great price.

Our Ascorbic Acid has been independently verified as Non-Corn.


2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155www.mcguff.com2

WE PROVIDE THE SERVICES YOU NEEDWe intentionally put the word “Services” in our name as it is our desire to serve the physicians and patients who need our expertise, preparations and help. Our pharmacists’ help our customers in any way needed.

We also empower our knowledgeable customer service representatives to handle questions, issues and problems while you are on the telephone with us.

Here is a brief list of how we typically help our customers…

• Physicians are not limited to “commercially available drugs”

• Physicians can treat patients with customized compounded preparations

• Compounded preparations may improve patient compliance and well-being

• Compounded preparations allow alternative methods for treating patients

• Physicians may prescribe treatments designed specifically for individual patients

Each person’s reaction to a particular medicinal substance (natural or synthetic) is different. Difficult to predict patient risk factors include fast versus slow metabolism, bioavailability, side effects, and cellular transport. This biochemical individuality can pose difficult barriers to appropriate prescribing with commercially available drugs. Compounding allows you to respond to each person’s uniqueness in an individualized way.

No longer are you limited to “standard medicine.” With compounding, your choices include changes of routes of administration, unique potency, pharmaceutical combinations and the ability to develop new, helpful compounds.

Integrating compounded preparations into your practice is simple. It requires no special equipment or financial investment. It will take a minimal amount of time to develop a relationship with our compounding pharmacy that can help with treatment regimens. The investment of time will yield dividends far greater than you may expect.

Compounded preparations may enhance your practice by improving patient well-being. You have already taken the time to understand your patient’s unique needs so why not prescribe a treatment designed specifically for the needs of your patient.

HOW COMPOUNDED PREPARATIONS MAY BENEFIT YOUR PATIENTS

• We price our compounded preparations to provide exceptional value • Our goal is to ship the same day the order is received• Customized shipping• Pharmacists and trained customer service representatives process your orders and answer questions• Patients are provided with Universal Insurance Claim Forms • Quality patient consultation by a pharmacist• Patients may use our internet site to reorder prescription preparations


www.mcguff.com

McGUFF IS THE BEST CHOICE FOR YOUR COMPOUNDING NEEDS

EXECUTIVE SUMMARY

All compounding pharmacies are not alike and vary widely in Pharmacist expertise, quality control, regulatory compliance, customer service and price. A major reason for this is that pharmacies, unlike commercial drug manufacturers, are regulated primarily by individual states and not by the Food and Drug Administration (FDA).

By design, McGuff Compounding Pharmacy shares the same physical facility with McGuff Pharmaceuticals, Inc., an FDA inspected, cGMP compliant pharmaceutical manufacturing company. The pharmacy and manufacturing companies benefit from shared facilities, shared equipment (when appropriate), quality assurance systems and staff cross-training.

McGuff Compounding Pharmacy is superior because we chose to achieve the highest standards possible.

We chose to:• expend the time, energy and money to be independently inspected.• become certified to meet the American National Standard for Quality Systems represented by ISO9001-2008.• become certified to meet Pharmacy Compounding Accreditation Board (PCAB) Standards. • meet or exceed the compounding standards set forth in United States Pharmacopeia Chapters <795> and

<797>.

We chose to respect and adhere to the laws and regulations of each state… and the list goes on…

McGuff Compounding Pharmacy has provided expertise and preparations for phase I, II and III IND clinical trials for various clients including, but not limited to; the University of California, Los Angeles, University of California, Irvine Pediatrix Medical Group, Inc., Obstetrix Medical Group, and Medtronic.

It is our experience, expertise, dedication and our willingness to help you that makes McGuff Compounding Pharmacy Services superior to all the others.

Let us know how we may help you add the benefits of compounded preparations to your practice.

We price our compounded preparations to provide exceptional value

We are accredited by the Pharmacy Compounding Accreditation Board (PCAB)

We are independently certified to meet American and International Standards for Quality Systems

We are compliant with United States Pharmacopeial Chapters <795> and <797>.

We are recognized by peers for business acumen, pharmaceutical expertise and state-of-the-art

facility design

We are able to help create new formulations based upon your patient’s needs


Chelation¹ TherapyAscorbic Acid Vitamin B-Complex 100*Dexpanthenol Edetate Disodium (EDTA)Edetate Calcium DisodiumHeparin Sodium* Magnesium Chloride/Magnesium Sulfate* Potassium Chloride* Procaine Hydrochloride Pyridoxine Hydrochloride Sodium Bicarbonate* Thiamine HydrochlorideIV Solutions*IV Administration Sets* Winged Infusion Sets*

Nutritional Support Q.S. Multi Vitamin - Multi Mineral Supplements*

Amino AcidsAcetylcysteineAlanineAminosynArginineCysteineD,L- AlanineGlutathioneGlycineIsoleucineLeucineLysineMethionineN-Acetyl-L-CysteinePhenylalanineProlineTaurineThreonineTyrosineValine

1.Protocol by: American College for Advancement in Medicine2.Protocol by: Jonathan Wright, M.D.3.Protocol by: John Myers, M.D. as modified by Alan Gaby, M.D.

*Commercial items will ship from McGuff Company, Inc. 1-800-834-7220

A SAMPLING OF SUPPORTED THERAPIESFor Sensitive ChildrenMethylcobalaminGlutathioneChelating Agents (DMPS, DMSA, etc.)Low Dose Naltrexone

We can custom formulate compounds that are free of yeast, wheat, gluten, casein, dye, sugar & preservatives.

Comprehensive RemineralizationI.V. Solution in 250mL 0.45% NaCL,Containing 14 Minerals² Calcium Gluconate Boron Copper Manganese Chloride Nickel Chloride Selenium Vanadium Magnesium SulfateChromiumLithiumMolybdenumRubidiumStrontiumZinc Chloride

Aminosyn 8.5%Amino Acid Infusion

Dermatologic Compounds/Skin CareCustom Facial PeelsCustom Bleaching CreamsEstradiol Face CreamsCustom Wart RemoversCustom topical anesthetics

Modified Myers’ Cocktail³Ascorbic AcidB-Complex 100*Calcium Gluconate*DexpanthenolPyridoxineHydroxocobalamin*Magnesium Chloride

Custom formulations of modified Myers’ Cocktail available upon request


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CapsulesDHEA SREstradiolLevothyroxine SR (T4)Liothryonine SR (T3)Progesterone SRPregnenolone

Creams and GelsDHEAEstradiolProgesterone Testosterone Pregnenolone

Sublingual Solutions / Troches DHEAEstradiolProgesterone Testosterone

McGUFF PROVIDES FULL SERVICE HRTOur team of professionals specialize in Women’s Health

– Hormones and consulting

– Vaginal and rectal pain

– Patient counseling

McGuff’s ISO Quality Systems help assure medications are available when you need them.

“McGuff provides support to physicians prescribing Hormone Replacement Therapy. Consultations are also available for product formulation and patient follow-up.”

Clay Hammett., Pharm.D.Compounding Pharmacist & Treatment SpecialistMcGuff Compounding Pharmacy Service, Inc.

HORMONE REPLACEMENT THERAPY

“My McGuff Pharmacist worked with my doctor to give me my life back.”

- Betty S. Newport Beach , CA

McGuff Provides Full-Service Hormone Replacement Therapy

Call us at (877) 444-1133.


INJECTABLE MEDICATIONS (Page 1 of 3)

We have made over 3,500 Compounded Preparations. Here is a short list:

COMPOUNDED PREPARATIONS LIST

Ascorbic Acid (Non-Corn) 500 mg/mL 50 mL PFV

Ascorbic Acid 222 mg/mL 30 mL MDV

Acetylcysteine 100 mg/mL 30 mL MDV

Acetyl-L-Carnitine 200 mg/mL 10 mL PFV

Amino Acid 8.5% (2747) 50 mL PFV

Amino Acid 8.5% (2748) 100 mL PFV

Arginine HCL 50 mg/mL 30 mL PFV

Arginine HCL 100 mg/mL 30 mL MDV

Biotin 10 mg/mL 30 mL PFV

Carnitine 500 mg/mL 30 mL MDV

Chromium 200 mcg/mL 30 mL PFV

Copper Trace Element 0.4mg/mL 10mL PFV

Cyanocobalamin 1,000 mcg/mL 30 mL PFV

Dexpanthenol 250 mg/mL 10 mL PFV

Dexpanthenol 250 mg/mL 30 mL PFV

Dexpanthenol 250 mg/mL 30 mL MDV

Dextrose, Methylcobalamin, Procaine 100 mL PFV

DMPS (DimercaptopropaneSulfonate) Sodium 50 mg/mL 5 mL SDV

Edetate Calcium Disodium 200 mg/mL 15 mL SDV

Edetate Disodium (EDTA) 150 mg/mL 20 mL SDV

Edetate Disodium (EDTA) 150 mg/mL 100 mL PFV

Folic Acid 10 mg/mL 10 mL MDV

Folic Acid 10 mg/mL 10 mL PFV



Glucosamine HCL 200 mg/mL 30 mL PFV

Glycerin 72% (v/v) 30 mL MDV

Glycine 50 mg/mL 30 mL MDV

Hydrochloric Acid 1:500 100 mL PFV

Hydrochloric Acid 1:500 30 mL MDV

Hydrogen Peroxide 3% 2.5 mL SDV

Hydrogen Peroxide 3% 30 mL PFV

Hydroxocobalamin 1,000 mcg/mL 5 mL PFV



Hydroxocobalamin 5,000 mcg/mL 30 mL MDV




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Hydroxocobalamin 10,000 mcg/mL 30 mL MDV


Inositol 50 mg/mL 30 mL MDV

L-Glutathione 60 mg/mL 30 mL MDV

L-Glutathione 100 mg/mL 10 mL PFV


L-Glutathione 100 mg/mL 30 mL PFV

L-Glutathione 200mg/mL 5 mL PFV


L-Glutathione 200mg/mL 30 mL PFV

Lipoic Acid 25 mg/mL 30mL PFV

Lipoic Acid 40 mg/mL 15mL PFV

Lipoic Acid 40 mg/mL 30 mL MDV

L-Tryptophan 30 mg/mL 30 mL MDV

Lysine 100 mg/mL 30 mL MDV

Magnesium Chloride 200 mg/mL 30 mL PFV

Magnesium Chloride 200 mg/mL 50 mL PFV

Manganese 2 mg/mL 30 mL PFV

Methionine 25 mg/mL, Inositol 50 mg/mL, Choline Chloride 50 mg/mL (M.I.C.) 30 mL MDV

Methionine 50 mg/mL 30 mL PFV

Methylcobalamin 10 mg/mL, Procaine 1% 10 mL PFV

Methylcobalamin 20 mg/mL 1 mL SDV

Methylcobalamin 1 mg/mL 5 mL MDV

Methylcobalamin 1,000 mcg/mL 5 mL PFV

Methylcobalamin 1,000 mcg/mL 30 mL MDV







M.I.C. + Supplements (2528), 10 mL MDV

M.I.C. + Supplements (0626), 30 mL MDV

Niacinamide 100 mg/mL 30 mL MDV

Phosphatidylcholine 50 mg/mL 30 mL MDV

Procaine 20 mg/mL (2%) 30 mL MDV

Procaine HCL 10 mg/mL (1%) 30 mL MDV

Procaine HCL 10 mg/mL (1%) 30 mL PFV







MDV = Multiple Dose Vial PFV = Preservative-Free Vial


Pyridoxine 100 mg/mL 5 mL PFV

Pyridoxine 100 mg/mL 10 mL PFV

Pyridoxine 100 mg/mL 30 mL MDV

Pyridoxine HCL 100 mg/mL 30 mL PFV

Riboflavin 50 mg/mL 30 mL MDV

Riboflavin-5’-Phosphate Sodium 10 mg/mL 30 mL MDV

Sodium Ascorbate 500mg/mL100 mL PFV

Taurine 50 mg/mL 5 mL PFV


Taurine 75 mg/mL 30 mL MDV

Taurine 100 mg/mL 30 mL MDV


Thiamine HCL 100 mg/mL 30 mL MDV

Thiamine HCL 100 mg/mL 30 mL PFV

Thiamine HCL 500 mg/mL 30 ML PFV

Vitamin B Complex-100 2 mL PFV



Vitamin D3 Water Miscible IM Injection 10,000 IU/mL 30 mL MDV

Zinc (as Chloride) 10 mg/mL 30 mL PFV



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Anastrozole 50 mcg Capsule



Chrysin 100 mg Capsule

DHEA (Dehydroepiandrosterone) 10 mg SR Capsule

DHEA (Dehydroepiandrosterone) 25 mg SR Capsule

DMPS (DimercaptopropaneSulfonate) Sodium 100 mg Capsule



DMSA (Dimercapto Succinic Acid) 200 mg Capsule

DMSA (Dimercapto Succinic Acid) 500 mg Capsule

Hydrocortisone 2.5 mg SR Capsule

Hydrocortisone 5 mg SR Capsule

Liothyronine Sodium 10 mcg SR Capsule

Liothyronine Sodium 12.5 mcg SR Capsule




Ketamine HCL 1% (10 mg/mL) Syrup

Ketamine HCL 2% (20mg/mL) Syrup

Ketamine HCL 2% (20 mg/mL) Syrup

Naltrexone HCL 1mg/mL Oral Liquid

Naltrexone HCL (Lactose-Free) 3 mg Capsule

Naltrexone HCL (Lactose-Free) 4.5 mg Vegetable Capsule

Naltrexone HCL 1 mg Capsule

Naltrexone HCL 1.5 mg Capsule



Naltrexone HCL 4.5 mg Capsule

Naltrexone HCL 4.5 mg, Lactose-Free Capsule

Naltrexone HCL 4.5mg, Lactose-Free, Dye-Free Capsule

Progesterone 50 mg SR Capsule





This is a list of commonly ordered compounded medications. If you have a specific medication that you would like to have compounded,

please call us at (877) 444-1133.

ORAL MEDICATIONS


CREAMS / GELS

Benzocaine, Lidocaine HCL, Tetracaine HCL 20%, 6%, 4% Cream 2 oz

Benzocaine, Lidocaine HCL, Tetracaine HCL 20%, 6%, 4% Cream 4 oz

DHEA 1.3% (13mg/gm) Vaginal Cream 30gm

Estradiol 0.005% (0.05mg/gm) Cream, 30 gm Tube

Estradiol 0.05% (0.5mg/gm) Cream 60 gm

Estradiol 0.0625% (0.625mg/gm) / Progesterone 12% (120mg/gm) Cream 60 gm




Estradiol 0.1% (1mg/gm) Cream 60 gm

Estradiol 0.1% (1mg/gm) / Progesterone 10% (100mg/gm) Cream 60 gm







Estradiol 0.3% (3mg/gm) Gel 60 mL

Gabapentin 6% Ointment 60 gm

Hydroquinone 4% / Tretinoin 0.05% / Dexamethasone Phosphate 0.1% Cream 30gm

Ketamine HCL 10% / Gabapentin 6% / Clonidine 0.2% PLO Gel 60 gm

Ketamine HCL 10% / Ketoprofen 10% PLO Gel 60 gm

Ketamine HCL 10% / Ketoprofen 10% / Baclofen 2% PLO Gel 60gm

Naltrexone 0.45% (4.5mg/gm) Cream 30gm

Progesterone 4% (40mg/gm) Cream 60 gm


Progesterone (Yam) (100mg/gm) 10% Cream 60 gm



Testosterone 0.2% (2mg/gm) Cream 60 gm

Testosterone 0.4% (4mg/gm) Cream 60 gram

Testosterone 0.4% (4mg/gm) PLO Gel 60 grams

Testosterone 0.4% (4mg/gm) / DHEA 5% (50mg/gm) Cream 60gm

Testosterone 0.8% (8mg/gm) Cream 60 gm

Testosterone 10% (100mg/gm) / Chrysin 10% (100mg/gm) Cream 60 gm

Testosterone 10% (100mg/gm) Cream 60gm

Testosterone 10% (100mg/gm) PLO Gel 60 gm

Testosterone 12% (120mg/gm) Cream 60 gm



TOPICAL MEDICATIONS (Page 1 of 2)


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SUBLINGUAL MEDICATIONSDHEA Troche

Estradiol Troche

Pregenolone Troche

Progesterone Troche

Testosterone 100 mg Troche

SUPPOSITORIESBaclofen 4mg/ Diazepam 5mg Suppository

Baclofen 20 mg Suppository

Baclofen 20mg, Gabapentin 60mg Suppository

Baclofen 30 mg Suppository

Baclofen 30 mg, Gabapentin 60 mg Suppository

Cyclobenzaprine HCL 10mg, Diazepam 5mg, Lidocaine 62.5mg Suppository

Diazepam 2 mg Suppository

Diazepam 5 mg Suppository

Ketamine HCL 30 mg Suppository

L-Glutathione 100 mg/mL 30 mL PFINH

L-Glutathione 200 mg/mL 30 mL MDINH

L-Glutathione 200 mg/mL 30 mL PFINH

Acetylcholine Chloride 10% 100 mL Solution

Dyclonine HCL 1% (10mg/mL) Dental Solution 60 mL

Lidocaine HCL 4%, Epinephrine 1:1000, Tetracaine HCL 0.5% (L.E.T.) Topical Solution 5 mL

Retinoic Acid 0.4% Topical Solution 120 mL

Trichloroacetic Acid 7%, Salicylic Acid 2% Topical Solution 120 mL

TOPICAL MEDICATIONS (Page 2 of 2)

INHALATION

TOPICAL SOLUTIONS

This is a list of commonly ordered compounded medications. If you have a specific medication that you would like to have compounded,

please call us at (877) 444-1133.


McGuff Compounding Pharmacy Services relies heavily on a certified quality control system to verify that all of our processes are in control and that we are compounding preparations that meet our customer’s specifications. We strongly believe that quality is built into our products.

Our in-house laboratories include Microbiology, Chemistry and Engineering. Through our laboratories and other FDA reviewed contract laboratories, we have implemented a myriad of various tests to ensure the final preparations we compound meet our customers specifications.

Our in-house finished preparation testing for identity and potency includes methods such as High Performance Liquid Chromatography (HPLC), Gas Chromatography, Titrations, pH, and many others. Biological tests for purity such as endotoxin content, sterility testing, bioload, and total organic carbon analysis are also fundamental in our testing programs.

We create and implement written testing programs and procedures to ensure national and international standards are met in the preparation and testing of our compounded preparations.

Our operating philosophy is to ensure physicians and patients, who rely on our compounded preparations, will always receive the superior quality that everyone has come to expect from McGuff Compounding Pharmacy Services, Inc.

LABORATORY TESTING OF PREPARATIONS

Quality From Start to Finish, At a Price You Can Afford!

See page 7 for details...

GLUTATHIONEReduced INJECTION

(877) 444-1133 | mcguffpharmacy.com


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McGUFF PHARMACY LABELS FOLLOW USP CHAPTER <797>

REGULATORY REQUIREMENTS

Refrigerate 2o - 8o C (36o - 46o F)Do Not Freeze

PROTECT FROM LIGHT

DILUTE BEFORE INTRAVENOUSE USE

Intramuscular injection may be painful

Lot No: 13 xxxxxxxDo not use beyond: xxxx

Sterile 30mL Multiple Dose Vial

GLUTATHIONEReduced INJECTION

200mg/mLFOR SLOW INTRAVENOUS USE ONLY

Compounded for a licensedprofessional or patient use by:

Compounding Pharmacy Services, Inc.Santa Ana, CA 92704

1-877-444-1133 www.mcguff.com

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Conditions and storage temperatures to protect the integrity of the product.Special Precautions. Lot number for component identification for each batch.Do not use beyond dating that meets USP requirements and/or McGuff Pharmacy’s stabilities studies.Our contact information so physicians and patients know who to call.Product Identification Number.Complete listing of all ingredients.Easy to locate vial identification.Concise notification that preparation has been compounded.

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Each mL contains:Glutathione (Reduced)200mg with Benzyl Alcohol 0.9% as preservative, in Water for Injection q.s. Sodium Bicarbonate and/or Sodium Hydrochloric Acid may have been used to adjust pH. (pH range 4.0 7.4)

Rx Only - Not For Resale

2042

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Flip off vial cap

Clear and amber vials. Amber vials protect light sensitive products

Vials are washed, sterilized and depyrogenated by McGuff Phar-macy to assure product integrity

S-450 High performance permanent label adhesive to assure label cannot be removed from vial

Gray Butyl stoppers are sterilized by McGuff Pharmacy

Neck space is filled with sterile, inert nitrogen gas to prevent oxidation of product

Type 1 borosilicate glass vials meet or exceed all USPrequirements for “Injection”

Non-punctured rubber stopper assurescontamination free product

McGUFF PHARMACY VIALS

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McGuff is Dedicated to Assisting Investigators with ResearchMcGuff is uniquely positioned to assist clinical trial investigators, directors and sponsors to perform investigational New Drug clinical trial phases 1, 2, and 3.

We have two companies that can provide clinical trial services: McGuff Compounding Pharmacy Services, Inc. (MCPS), a compounding pharmacy; and McGuff Pharmaceuticals, Inc. (MPI), an FDA-reviewed manufacturer. McGuff Compounding Pharmacy and McGuff Pharmaceuticals employ pharmacists, engineers, regulatory affairs, quality assurance and other personnel that have experience performing clinical trials.

Our management team applies relationship management principles with clinical trial investigators, directors and sponsors. We build teamwork by staying focused on important issues that make a difference. McGuff Compounding Pharmacy Services, Inc. provides one of today’s most striking examples of advanced technology and creative management by assuring all cGMP, quality, and business standards are met in the critical areas of clinical trial development and execution.

Our senior management team has extraordinary experience in clinical trial development. Senior management expertise includes Pharmacology, Biochemistry, Microbiology, Engineering, Analytical Chemistry, Business Management and other related technologically demanding disciplines.

Our pharmacists bring a wide variety of additional knowledge with their experiences working in hospitals, nuclear pharmacy, community pharmacy settings, chemical industry, and commercial pharmaceutical manufacturing.

McGUFF CLINICAL TRIAL SERVICES

Contact information:Doug Tran, Pharm.D., Manager of Clinical Trial Assessment Phone: 1-877-444-1133 Email: [email protected]

Examples of services provided include:

Design and custom compounding or manufacturing of active and placebo drug dosage forms

Assemble clinical trial patient kits & documentation

Process validation, test method validation, software validation

Create Part 11 compliant web interfaces to gather, process and transmit date securely

Investigational New Drug Application support documentation and consultatione

Testimonials:“The reason[s] for choosing McGuff Co. as the study drug provider for the FASTMAG trial included demonstrated

expertise in preparation of clinical trial products, ISO and FDA/cGMP credentialing, high level of professionalism, flexibility and innovation in addressing the specific requirements of our trial, and responsive customer service.” ~ Jeff Saver, MD, UCLA Neurology

“We just wanted to send you a quick thank you for all of your efforts over the last couple of months! We know it has been pretty crazy! We appreciate the time you have put into the project and the results we have seen thus far.” ~ Kelley, Jonathan and the Travanti Inc. Team


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• Lactose Free• Dye Free• Vegi Capsules• Oral Liquid• Topical

See pages 9 & 10for details.

We compound low dose Naltrexone to meet your patient’s specific needs:

LOW DOSE NALTREXONE


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IMPORTANT INFORMATION REGARGING DRUG SHORTAGESThe McGuff Companies are dedicated to providing our customers with the highest quality products at the lowest possible prices. On every occasion we try to provide FDA approved commercial drugs to our customers as these drugs provide the highest assurance of patient safety and best value.

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. For up-to-date information, visit www.mcguffmedical.com/DrugShortages.aspx

McGuff Company: (800) 854-7220McGuff Pharmacy: (877) 444-1133


www.mcguff.com 5

International Journal of Compounding Pharmacy - Circulation 7,000McGuff Compounding Pharmacy Services and McGuff Pharmaceuticals havealways maintained a positive relationship with the FDA. Early in the planning stages for each of the new companies, management sought and received FDA input and guidance to ensure compliance with federal regulations. “We have always worked closely with the FDA staff ” said Blair. “Rather than being uncomfortable with their interest, we welcome their ongoing inspections and their efforts to protect public health. We want to learn from them, and we’re always interested in identifying areas that need improvement. We supply the FDA with as much [control and process] information as we can, and have carefully documented procedures for doing so.“

McGuff Compounding Pharmacy has become a noted member of the professional community and has been recognized for our business acumen, pharmaceutical expertise and facility design. Exerts from leading publications and academia:

NEWS-Line for Pharmacists - Circulation 8,500“At McGuff Compounding Pharmacy Services, Inc. (MCPS) in Santa Ana, California, William Blair, PharmD, MBA, is at the center of operations-literally. His office is built right in the middle of the facility with windows looking out over every aspect of operations, from the production to the development of all of the pharmacy’s products. It’s a design that allows Blair, the director of pharmacy services at MCPS, to keep tabs on everything that is going on at the nation’s only ISO9001:2008 certified facility of its kind.”

CleanRooms Magazine - Circulation 34,000 “One of the best examples of a well designed and built cleanroom environment is at McGuff Compounding Pharmacy. I recently had the opportunity to tour their facility, and it is nearly impeccable… “One of the key elements,” according to Damon, [Damon Jones, MBA, Vice President of Operations, McGuff Pharmaceuticals, Inc.] “Was the placement of equipment to maximize process efficiency while minimizing possible turbulence in the airflow.” To reduce the possibility of cross-contamination in the more critical environments, McGuff used the “single pass” method of providing conditioned air to the controlled environment(s).”

Fourth Year Pharmacy Students Train at McGuff Compounding PharmacyMcGuff Compounding Pharmacy has been selected by the University of California, San Francisco, School of Pharmacy to provide Advanced Pharmacy Practice Experience to fourth year students in the Doctor of Pharmacy program. This program is designed to help students understand twenty-one skill sets involved in compounding pharmacy practice.

California Pharmacist - Circulation 5,500“In December 2006, McGuff Compounding Pharmacy Services, Inc. (MCPS) earned PCAB’s Seal of Accreditation for its compounding services… The PCAB will serve as a backbone of quality assurance for all of their services. They [MCPS] will continue to not only educate both practioners and the public on the significance of accreditation, but open their doors to other pharmacists who hope to learn more about the process and become accredited as well.”

McGUFF IS RECOGNIZED BY PEERS AS A LEADER


McGuff Pharmaceuticals Inc. (MPI), a FDA registered cGMP manufacturer, produces Water for Injection for the pharmacy. This picture shows an operator reading a chart from a Water for Injection Still. We know of no other compounding pharmacy that has access to its own Water for Injection System!

PHOTO GALLERY: Images From Our Pharmacy

Pharmacist’s office within ISO class 8 core.

We rely on calibration, qualifcation and validation. This is a cornerstone of our ISO 9001:2008 certification and how we build quality into our products.

Vacuum chamber to test vials for leaks after crimping. Please note we test vials upside down!

Our laboratory, run by our independent quality systems department, tests for sterility, endotoxin, and potency.

ISO class 7 and class 5 aseptic filling room


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C r e a m s , O i n t m e n t s , C a p s u l e s , Troches, Suppositories and many other forms of drugs are available.

Our Water for Injection System is kept hot 65º to 85º Celcius to protect from biological contamination.

A l l c o m p o u n d i n g ( n o t t o b e c o n f u s e d w i t h a s e p t i c f i l l i n g ) o c c u r s i n s p e c i a l r o o m s w i t h independent air handling systems to prevent cross contamination.

In association with MPI, the pharmacy has access to washed and depyrogenated vials. This picture shows some of the controls of our depyrogenation oven.

Chapter <797> of the USP states that a laminar flow workbench shall be qualified no less than every six months. Our Pharmacy laminar air flow is sampled and analyzed for air particulates every minute. A significant improvement over Chapter <797> requirements.

Water for injection holding tank which is part of our ”continuous loop” WFI System


Bill, as Director of Pharmacy, is responsible for all pharmacy operations. His unique persona touches every aspect of the pharmacy: employees, vendors, patients and physician customers. Bill enjoys the time he spends talking with physician customers and patients both locally, on the telephone and over the Internet. His broad knowledge on compounded preparations, physician/patient protocols and regulatory compliance helps ensure a smooth transfer of information from the pharmacy to our customers.

Education Summary:Pharm.D., University of California, San Francisco. ASHP Residency, and M.B.A. Degree from the University of California, Irvine. Assistant Clinical Professor, University of California, San Francisco, School of Pharmacy.

Specialized Training:Sterile and Non-Sterile Drug CompoundingISO 9001:2008 Quality SystemsCode of Federal Regulations Part 21 cGMP ComplianceResearch and Product Development

William J. BlairPharm.D., MBA

Vice President and Director of PharmacyMcGuff Compounding Pharmacy Services

Doug, who has a natural interest and vast experience in analytical chemistry, manages our approach to the physical, chemical, regulatory and quality system requirements of sterile product development in the pharmacy. Doug is also responsible for research and approval of all compounds used in our Clinical Trials contract work. We are pleased that Doug continues to expand his knowledge and extensive experience in pediatric clinical pharmacy.

Education Summary: Pharm.D., University of California, San FranciscoBS, Biochemistry/Chemistry, University of California, RiversideAssistant Clinical Professor, University of California, San Francisco, School of Pharmacy Specialized Training:Sterile and Non-Sterile Drug CompoundingISO 9001:2008 Quality SystemsCode of Federal Regulations Part 21 cGMP Compliance

Member:California Pharmacist AssociationOrange County Pharmacist Association

Doug TranPharm.D.

Manager of Product Services & Clinical Trials AssessmentMcGuff Compounding Pharmacy Services

PHARMACIST PROFILES


www.mcguff.com

Si is in charge of sterile and nonsterile pharmacy formulations. Si, with his well-rounded knowledge of sterile and nonsterile pharmacy compounding, preparation development, research, aseptic techniques and customer support, provides assistance wherever and whenever it is needed. Si is the person to call if you have questions about the pharmacy or the preparations we compound.

Education Summary:Pharm.D. University of Southern CaliforniaBS, Biology, University of California, IrvineAssistant Clinical Professor, University of California, San Francisco, School of Pharmacy

Specialized Training: Sterile and Non-Sterile Drug Compounding ISO 9001:2008 Quality Systems Code of Federal Regulations Part 21 cGMP Compliance Research and Product Development

Si PhamPharm.D.

Pharmacist, Sterile and Non-Sterile Compounding

Richard chose to enter the pharmacy profession because of his desire to be part of a team that works towards improved patient well-being and to provide the personal care to patients that we all seek. His background in retail and nuclear pharmacy combined with knowledge of Information Technology systems makes Rich an important member of our team. Rich chairs our Safety Committee and answers drug information requests, compounds sterile and non-sterile preparations, supervises pharmacy technicians and students, assists in research, and performs patient counseling.

Education Summary:B.S. Degree, Pharmacy, Long Island UniversityB.A. Degree, Economics, Cornell University

Specialized Training:Nuclear PharmacySterile and Non-Sterile Drug CompoundingISO 9001:2008 Quality SystemsCode of Federal Regulation Part 21 cGMP Compliance

Richard HsuR.Ph.


PHARMACIST PROFILES (continued)


Clay has an extensive background in clisnical and compounding pharmacy. Clay has formulated a wide variety of custom compounds . In so doing, Clay is able to form a true partnership with clinicians and their patients, working as a team to solve patient health issues. Clay is excited to answer questions about bio-identical hormones, pain formulations, dermatology, vaginal/rectal pain issues, dentistry problems, or any area that requires a non-sterile compounding solution.

Education Summary:Pharm.D. University of Southern CaliforniaBS, Biology, University of California, Irvine


Clay HammettPharm.D.

Compounding Pharmacist & Treatment Specialist

Damon, as Vice President of Operations for McGuff Pharmaceuticals, plays an important role not only for us at the pharmacy, but for all our patients as well. Damon, because of his in-depth education and experience in microbiology, Current Good Manufacturing Practices, International Quality Systems, and Laboratory Practices, has become our pharmacy in-house consultant. His overview of pharmacy quality system adds a valuable perspective to assure that “quality is designed into our products” .

Education Summary: Masters Business Administration, University of Phoenix, ArizonaB.S. Degree, Microbiology, California State University Long Beach

Specialized Training:Certified Quality Engineer, American Society for QualityFaculty, Department of Engineering, California State University FullertonAssistant Clinical Professor, University of California, San Francisco

Damon JonesMBA, CQE

Vice President and Director of OperationsMcGuff Pharmaceuticals, Inc.



www.mcguff.com

Margaret has a passion to help others improve their health and well-being. Her dedication to provide quality care is an asset to the McGuff Compounding Pharmacy Services, Inc. team. With her vast knowledge in hospital, retail, and especially compounding pharmacy, Margaret can contribute her past experiences to the pharmacy’s growing success. Margaret has practiced in both sterile and non-sterile compounding for many years with an emphasis in Hormone Replacement Therapy. Education Summary: Pharm.D., University of Southern CaliforniaBiochemistry, Pierce College

Specialized Training:Sterile and Non-Sterile Drug CompoundingISO 9001:2008 Quality SystemsCode of federal Regulations Part 21 cGMP ComplianceResearch and Product Development

Margaret ChengPharm.D.


Gene is the most recent staff pharmacist to join the McGuff CPS team. He has extensive experience in hospital, retail, and most recently, 12 years of compounding pharmacy experience with both sterile and non-sterile preparations. Gene utilizes a wealth of knowledge from retail pharmacy management to enhance the services provided by McGuff CPS. He is involved with all aspects of operations, including answering drug information questions, determining which preparations to compound, supervising pharmacy technicians and providing excellent customer care.

Education Summary:Pharm.D., Northeastern University, Boston


Gene SamborskyPharm.D. Pharmacist, Sterile and Non-Sterile Compounding



Nicholas joined the McGuff Compounding Pharmacy Services team in 2010. With over 20 years of pharmacy experience, Nicholas utilizes a wealth of knowledge from retail pharmacy to enhance the services provided by McGuff Compounding Pharmacy Services, Inc.

Nicholas is responsible for overseeing pharmacy technicians, answering drug information matters, formulating new compound preparations, and offering exceptional customer care.

Education Summary: B.S. Degree, Pharmacy, Temple University

Specialized Training:Sterile and Non-Sterile Drug CompoundingISO 9001:2008 Quality SystemsCode of federal Regulations Part 21 cGMP ComplianceResearch and Product Development

Nicholas DiamanantopoulousR.Ph. Pharmacist, Sterile and Non-Sterile Compounding



www.mcguff.com

COMPOUNDED PREPARATIONS: Disclosure Between PartiesOne of the primary goals of McGuff Compounding Pharmacy Services is to disseminate relevant information to professionals who provide health care to patients. It is important to us that you are informed about the regulatory environment that relates to prescribed compounded preparations.

Recently, there have been many changes and challenges to national and state regulations that govern compounding pharmacies, physicians, and patients who use compounded preparations.

Regulatory and legal requirements surrounding compounded preparations suggest “disclosure” be made between all parties in the patient-physician-pharmacist triad.

As part of our disclosure we want to reinforce that there are two basic categories of drugs that can be ordered via prescription; commercially available drugs and compounded preparations (the term preparation is used to further differentiate compounded drugs from commercially available drugs).

Commercially available drugs (e.g. Premarin, Lasix, Inderal) are:• Manufactured by U.S. Food and Drug Administration (FDA) inspected firms that are compliant with Current Good Manufacturing Practices enforced by the FDA.• Available by prescription and are usually obtained at retail pharmacies such as Wal-Mart, Rite Aid, and CVS• Reviewed and approved by the FDA for safety and efficacy.• Approved by the FDA for one or more specific indications and contain package inserts that may explain usage, contraindications, warnings, precautions, adverse

reactions and drug incompatibilities.

Compounded preparations are: • Prepared by pharmacies that operate under state law, United States Pharmacopeia (USP) requirements and USP Good Compounding Guidelines.• Available by prescription from licensed pharmacies that are equipped to compound drugs such as McGuff Compounding Pharmacy Services, Inc.• Not reviewed by the FDA or State Boards of Pharmacy for safety and efficacy. • Not approved by the FDA for any indication and do not contain FDA reviewed package inserts that may explain usage, contraindications, warnings, precautions,

adverse reactions and drug incompatibilities.

Health care professionals should also take appropriate steps to educate their patients when a compounded preparation is prescribed.• Inform the patient that a physician has the right to prescribe compounded preparations based upon his/her knowledge of the patient’s health and his/her professional

knowledge of the preparation prescribed.

Additionally, the patient should be advised that the compounded preparation:• Is provided based upon the medical need of the individual patient.• Is prepared by a licensed pharmacy.• Has not undergone the FDA’s New Drug Application process and has not been reviewed or approved by the FDA for safety or efficacy.

Please let us know if you have any questions or thoughts about our disclosure policy. You may call us at 1-877-444-1133 or email us at [email protected].

(800) 854-7220 mcguffmedical.com

A Wholesale Company Specializing in IV Chelation Therapy and Alternative Therapies for over 34 years.

We offer:• IV Solutions

• Medical Devices

• Physician Office Supplies

• Oral Nutritional Supplements


“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” - Will A. Foster

McGuff Compounding Pharmacy Services, Inc. has pursued a philosophy of continuous quality improvement and strives to consistently provide the highest quality compounded preparations and customer service in the industry. In order to attain these lofty goals, we have implemented quality systems procedures, equipment and facility validations that not only meet USP Chapters <795> and <797> but

in many areas meet FDA Current Good Manufacturing Practices (an extremely difficult task to do). We are aware of no other compounding pharmacy that can make this claim.

If you are in the Southern California area we would be proud to have you drop by for a tour of our facility and meet our staff.

McGUFF MEETS NATIONAL AND INTERNATIONAL QUALITY STANDARDS

VERIFIED AND INDEPENDENTLY AUDITED QUALITY CONTROL STANDARDS• American National Standard; ISO 9001:2008 Quality Systems-Model for Quality Assurance: - Certification number: A0000139-9

• Pharmacy Compounding Accreditation Board (PCAB)

• California Board of Pharmacy - Sterile Compounding License number: 99004

• California Board of Pharmacy - Pharmacy License number: PHY43950

• Drug Enforcement Administration License Number: BM6241777

• We are licensed in every state that requires licensing

PHARMACYCOMPOUNDINGACCREDITATION

BOARD

The American Medical Association “encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB™ Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice.” - Source: American Medical Association (AMA) Resolution, H-120.945

To be compounded with the following minimum requirements:

McGuff Compounding Pharmacy meets or exceeds Dr. Berkson’s requirements:

Dr. Berkson Requires

LIPOIC ACIDInjection

• Raw material is manufactured in Europe and not in China.

• Formulation has no surfactants or organic solvents.

• Lipoic Acid Injection is potency tested using High-Pressure liquid chromatography (HPLC) method at an FDA registered lab.

The American Medical Association “encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB™ Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice.” - Source: American Medical Association (AMA) Resolution, H-120.945

• Our Lipoic Acid raw material is manufactured in Europe and not in China.

• Our Lipoic Acid formulation has no surfactants or organic solvents.

• Our Lipoic Acid Injection is potency tested using High-Pressure liquid chromatography (HPLC) equipment at an FDA registered lab.

• How supplied: Lipoic Acid Injection 40mg/mL 15mL preservative-free vial.


....

(877) 444-1133 | www.mcguffpharmacy.com

“Tahoma Clinic has used products from McGuff Pharmacy for over 10 years. We have consistently been satisfied with the high quality of McGuff's products and their excellent customer service.

We have especially appreciated McGuff Pharmacy's willingness to accomodate unique requests and search out specialized ingredients while maintaining competitive pricing."

Jonathan V. Wright, M.D.Medical Director, Tahoma Clinic, Renton, WA and Washington & Tahoma Clinic IV Room Staff

Testimonials from our good friends and health care advocates, Dr. Julian Whitaker and Dr. Jonathan V. Wright...

“Over the last 30 years, Whitaker Wellness has grown into one of the largest wellness clinics in the country. We could not adequately serve our patients without a strong working relationship with a compounding pharmacy to provide prescription items not available in conventional drugstores. We have such a relationship with McGuff Compounding Pharmacy.

We work with the pharmacists at McGuff on a daily basis and are exceedingly happy with their diligence, quality of products, and follow-up with our patients. I have complete trust in this pharmacy and would not hesitate to recommend it to anyone.”

Julian Whitaker, M.D.Whitaker Wellness Institute, Newport Beach, CA

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