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Transcript
Preparation and Service Guide
(877) 444-1133 | www.mcguff.com
Life is precious...
With your patients’ health on the line, there is no substitute for quality compounded drugs.
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.
Table of Contents
1
2
3
4
5
6
9
10
11
Terms Conditions & Helpful Information
Services We Provide & How Compounded
Preparations May Benefit Your Patients
McGuff is the Best Choice for Your
Compounding Needs
A Sampling of Supported Therapies
Hormone Replacement Therapy
Compounded Preparations Injectable Medications
Compounded Preparations Oral Medications
Compounded Preparations Topical Medications
Compounded Preparations Inhalation, Sublingual Medications, Suppositories
12
13
14
17
18
20
25
26
Laboratory Testing of Compounded
Preparations
McGuff Pharmacy Vial Information
McGuff Clinical Trial Services
McGuff is Recognized by Peers as a Leader
Photo Gallery: Images of Our Pharmacy
McGuff Pharmacists’ Profiles
Compounded Preparations: Disclosure
Between Parties
McGuff Meets National & International
Quality Standards
Terms, Conditions & Helpful Information
Customer Service Hours:
(877) 444-1133
7:00am - 5:30pm PST Monday - Friday
Address:
2921 West MacArthur Boulevard, Suite 142
Santa Ana, California 92704
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.
PHARMAC Y
COMPOUNDING
ACCREDITATION
BOARD
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
1
WE PROVIDE THE SERVICES YOU NEED
We 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…
• 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
HOW COMPOUNDED PREPARATIONS MAY BENEFIT YOUR PATIENTS
• 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.
2
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
McGUFF IS THE BEST CHOICE FOR YOUR COMPOUNDING NEEDS
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
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.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
3
A SAMPLING OF SUPPORTED THERAPIES
Chelation¹ Therapy
Ascorbic Acid
Vitamin B-Complex 100*
Dexpanthenol
Edetate Disodium (EDTA)
Edetate Calcium Disodium
Heparin Sodium*
Magnesium Chloride/Magnesium Sulfate*
Potassium Chloride*
Procaine Hydrochloride
Pyridoxine Hydrochloride
Sodium Bicarbonate*
Thiamine Hydrochloride
IV Solutions*
IV Administration Sets*
Winged Infusion Sets*
Nutritional Support
Q.S. Multi Vitamin - Multi Mineral Supplements*
Amino Acids
Acetylcysteine
Alanine
Aminosyn
Arginine
Cysteine
D,L- Alanine
Glutathione
Glycine
Isoleucine
Leucine
Lysine
Methionine
N-Acetyl-L-Cysteine
Phenylalanine
Proline
Taurine
Threonine
Tyrosine
Valine
1.Protocol by: American College for Advancement in Medicine
2.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
4
For Sensitive Children
Methylcobalamin
Glutathione
Chelating Agents (DMPS, DMSA, etc.)
Low Dose Naltrexone
We can custom formulate compounds that are
free of yeast, wheat, gluten, casein, dye, sugar &
preservatives.
Comprehensive Remineralization
I.V. Solution in 250mL 0.45% NaCL,
Containing 14 Minerals²
Calcium Gluconate
Boron
Copper
Manganese Chloride
Nickel Chloride
Selenium
Vanadium
Magnesium Sulfate
Chromium
Lithium
Molybdenum
Rubidium
Strontium
Zinc Chloride
Aminosyn 8.5%
Amino Acid Infusion
Dermatologic Compounds/Skin Care
Custom Facial Peels
Custom Bleaching Creams
Estradiol Face Creams
Custom Wart Removers
Custom topical anesthetics
Modified Myers’ Cocktail³
Ascorbic Acid
B-Complex 100*
Calcium Gluconate*
Dexpanthenol
Pyridoxine
Hydroxocobalamin*
Magnesium Chloride
Custom formulations of modified Myers’ Cocktail available
upon request
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
HORMONE REPLACEMENT THERAPY
Capsules
DHEA SR
Estradiol
Levothyroxine SR (T4)
Liothryonine SR (T3)
Progesterone SR
Pregnenolone
Creams and Gels
DHEA
Estradiol
Progesterone
Testosterone
Pregnenolone
McGUFF PROVIDES FULL SERVICE HRT
Our 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.”
Sublingual Solutions / Troches
DHEA
Estradiol
Progesterone
Testosterone
Clay Hammett., Pharm.D.
Compounding Pharmacist & Treatment Specialist
McGuff Compounding Pharmacy Service, Inc.
“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.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
5
COMPOUNDED PREPARATIONS LIST
We have made over 3,500 Compounded Preparations. Here is a short list:
INJECTABLE MEDICATIONS
(Page 1 of 3)
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
Folic Acid 10 mg/mL 30 mL MDV
Folic Acid 20 mg/mL 30 mL MDV
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 1,000 mcg/mL 10 mL PFV
Hydroxocobalamin 1,000 mcg/mL 30 mL PFV
Hydroxocobalamin 5,000 mcg/mL 30 mL MDV
Hydroxocobalamin 5,000 mcg/mL 30 mL PFV
Hydroxocobalamin 10,000 mcg/mL 10 mL PFV
6
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
INJECTABLE MEDICATIONS
(Page 2 of 3)
Hydroxocobalamin 10,000 mcg/mL 30 mL MDV
Hydroxocobalamin 10,000 mcg/mL 30 mL PFV
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 MDV
L-Glutathione 100 mg/mL 30 mL PFV
L-Glutathione 200mg/mL 5 mL PFV
L-Glutathione 200 mg/mL 30 mL MDV
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
Methylcobalamin 1,000 mcg/mL 30 mL PFV
Methylcobalamin 5,000 mcg/mL 30 mL MDV
Methylcobalamin 10,000 mcg/mL 10 mL MDV
Methylcobalamin 10,000 mcg/mL 10 mL PFV
Methylcobalamin 10,000 mcg/mL 30 mL MDV
Methylcobalamin 10,000 mcg/mL 30 mL PFV
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
Procaine HCL 10 mg/mL (1%) 50 mL PFV
Procaine HCL 20 mg/mL (2%) 10 mL PFV
Procaine HCL 20 mg/mL (2%) 30 mL PFV
Procaine HCL 20 mg/mL (2%) 100 mL PFV
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
7
INJECTABLE MEDICATIONS
(Page 3 of 3)
Procaine HCL 40 mg/mL (4%) 30 mL PFV
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 50 mg/mL 30 mL PFV
Taurine 75 mg/mL 30 mL MDV
Taurine 100 mg/mL 30 mL MDV
Taurine 100 mg/mL 30 mL PFV
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 B Complex-100 10 mL PFV
Vitamin B Complex-100 30 mL PFV
Vitamin D3 Water Miscible IM Injection 10,000 IU/mL 30 mL MDV
Zinc (as Chloride) 10 mg/mL 30 mL PFV
MDV = Multiple Dose Vial PFV = Preservative-Free Vial
8
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
ORAL MEDICATIONS
Anastrozole 50 mcg Capsule
Anastrozole 70 mcg Capsule
Anastrozole 100 mcg Capsule
Chrysin 100 mg Capsule
DHEA (Dehydroepiandrosterone) 10 mg SR Capsule
DHEA (Dehydroepiandrosterone) 25 mg SR Capsule
DMPS (DimercaptopropaneSulfonate) Sodium 100 mg Capsule
DMPS (DimercaptopropaneSulfonate) Sodium 250 mg Capsule
DMPS (DimercaptopropaneSulfonate) Sodium 300 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
Liothyronine Sodium 15 mcg SR Capsule
Liothyronine Sodium 16 mcg SR Capsule
Liothyronine Sodium 25 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 3 mg Capsule
Naltrexone HCL 4 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
Progesterone 75 mg SR Capsule
Progesterone 100 mg SR Capsule
Progesterone 150 mg SR Capsule
Progesterone 200 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.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
9
TOPICAL MEDICATIONS
(Page 1 of 2)
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 0.0625% (0.625mg/gm) / Progesterone 10% (100mg/gm) Cream 60 gm
Estradiol 0.075% (0.75mg/gm) / Progesterone 10% (100mg/gm) Cream 60 gm
Estradiol 0.075% (0.75mg/gm) / Progesterone 15% (150mg/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 0.125% (1.25mg/gm) / Progesterone 15% (150mg/gm) Cream 60 gm
Estradiol 0.125% (1.25mg/gm) Cream 60 gm
Estradiol 0.125% (1.25mg/gm) / Progesterone 10% (100mg/gm) Cream 60 gm
Estradiol 0.15% (1.5mg/gm) Cream 60 gm
Estradiol 0.2% (2mg/gm) Cream 60 gm
Estradiol 0.3% (3mg/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 5% (50mg/gm) Cream 60 gm
Progesterone (Yam) (100mg/gm) 10% Cream 60 gm
Progesterone 15% (150mg/gm) Cream 60 gm
Progesterone 20% (200mg/gm) 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
Testosterone 15% (150mg/gm) Cream 60 gm
Testosterone 20% (200mg/gm) Cream 60 gm
10
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
TOPICAL MEDICATIONS
(Page 2 of 2)
TOPICAL SOLUTIONS
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
INHALATION
L-Glutathione 100 mg/mL 30 mL PFINH
L-Glutathione 200 mg/mL 30 mL MDINH
L-Glutathione 200 mg/mL 30 mL PFINH
SUBLINGUAL MEDICATIONS
DHEA Troche
Estradiol Troche
Pregenolone Troche
Progesterone Troche
Testosterone 100 mg Troche
SUPPOSITORIES
Baclofen 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
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.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
11
LABORATORY TESTING OF PREPARATIONS
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.
GLUTATHIONE
Reduced INJECTION
Quality From Start to Finish,
At a Price You Can Afford!
See page 7 for details...
(877) 444-1133 | mcguffpharmacy.com
12
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
McGUFF PHARMACY LABELS FOLLOW USP CHAPTER <797>
REGULATORY REQUIREMENTS
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)
7
Rx Only - Not For Resale
6
8
Sterile 30mL Multiple Dose Vial
GLUTATHIONE
Reduced INJECTION
200mg/mL
2
FOR SLOW INTRAVENOUS USE ONLY
Compounded for a licensed 9
professional or patient use by:
1
PROTECT FROM LIGHT
DILUTE BEFORE
INTRAVENOUSE USE
2
Intramuscular injection may be painful
Compounding Pharmacy Services, Inc.
Santa Ana, CA 92704
1-877-444-1133 www.mcguff.com
2042
Refrigerate 2o - 8o C (36o - 46o F)
Do Not Freeze
Lot No: 13 xxxxxxx 3
Do not use beyond: xxxx
4
5
1 Conditions and storage temperatures to protect the integrity of the product.
2 Special Precautions.
3 Lot number for component identification for each batch.
4
5
6
7
8
9
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.
McGUFF PHARMACY VIALS
Non-punctured rubber stopper assures
contamination free product
Flip off vial cap
Neck space is filled with sterile,
inert nitrogen gas to prevent
oxidation of product
Type 1 borosilicate glass
vials meet or exceed all USP
requirements for “Injection”
Vials are washed, sterilized and
depyrogenated by McGuff Pharmacy to assure product integrity
Gray Butyl stoppers are sterilized
by McGuff Pharmacy
Clear and amber vials. Amber vials
protect light sensitive products
S-450 High performance
permanent label adhesive
to assure label cannot be
removed from vial
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
13
McGUFF CLINICAL TRIAL SERVICES
McGuff is Dedicated to Assisting Investigators with Research
McGuff 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.
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
Contact information:
Doug Tran, Pharm.D., Manager of Clinical Trial Assessment
Phone: 1-877-444-1133
Email: [email protected]
14
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
LOW DOSE
NALTREXONE
We compound low dose
Naltrexone to meet your
patient’s specific needs:
•Lactose Free
•Dye Free
•Vegi Capsules
•Oral Liquid
•Topical
See pages 9 & 10
for details.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
15
IMPORTANT INFORMATION REGARGING DRUG SHORTAGES
The 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) 854-7220
McGuff Pharmacy: (877) 444-1133
16
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
McGUFF IS RECOGNIZED BY PEERS AS A LEADER
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:
International Journal of Compounding Pharmacy - Circulation 7,000
McGuff Compounding Pharmacy Services and McGuff Pharmaceuticals have
always 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.“
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).”
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.”
Fourth Year Pharmacy Students Train at McGuff Compounding Pharmacy
McGuff 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.
5
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
17
PHOTO GALLERY: Images From Our Pharmacy
ISO class 7 and class 5 aseptic filling
room
Our laboratory, run by our independent
quality systems department, tests for
sterility, endotoxin, and potency.
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.
Pharmacist’s office within ISO class 8
core.
Vacuum chamber to test vials for leaks
after crimping. Please note we test vials
upside down!
18
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!
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
Our Water for Injection System is kept
hot 65º to 85º Celcius to protect from
biological contamination.
Creams, Ointments, Capsules,
Troches, Suppositories and many other
forms of drugs are available.
In association with MPI, the pharmacy
has access to washed and depyrogenated
vials. This picture shows some of the
controls of our depyrogenation oven.
All compounding (not to be
confused with aseptic filling)
occurs in special rooms with
independent air handling systems
to prevent cross contamination.
Water for injection holding tank which
is part of our ”continuous loop” WFI
System
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.
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
19
PHARMACIST PROFILES
William J. Blair
Vice President and Director of Pharmacy
McGuff Compounding Pharmacy Services
Pharm.D., MBA
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 Compounding
ISO 9001:2008 Quality Systems
Code of Federal Regulations Part 21 cGMP Compliance
Research and Product Development
Doug Tran
Pharm.D.
Manager of Product Services & Clinical Trials Assessment
McGuff 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 Francisco
BS, Biochemistry/Chemistry, University of California, Riverside
Assistant 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
Member:
California Pharmacist Association
Orange County Pharmacist Association
20
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
PHARMACIST PROFILES (continued)
Si Pham
Pharmacist, Sterile and Non-Sterile Compounding
Pharm.D.
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 California
BS, Biology, University of California, Irvine
Assistant 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
Richard Hsu
Pharmacist, Sterile and Non-Sterile Compounding
R.Ph.
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 University
B.A. Degree, Economics, Cornell University
Specialized Training:
Nuclear Pharmacy
Sterile and Non-Sterile Drug Compounding
ISO 9001:2008 Quality Systems
Code of Federal Regulation Part 21 cGMP Compliance
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
21
PHARMACIST PROFILES (continued)
Clay Hammett
Compounding Pharmacist & Treatment Specialist
Pharm.D.
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 California
BS, Biology, University of California, Irvine
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
Damon Jones
MBA, CQE
Vice President and Director of Operations
McGuff Pharmaceuticals, Inc.
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, Arizona
B.S. Degree, Microbiology, California State University Long Beach
Specialized Training:
Certified Quality Engineer, American Society for Quality
Faculty, Department of Engineering, California State University Fullerton
Assistant Clinical Professor, University of California, San Francisco
22
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
PHARMACIST PROFILES (continued)
Margaret Cheng
Pharmacist, Sterile and Non-Sterile Compounding
Pharm.D.
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 California
Biochemistry, Pierce College
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
Gene Samborsky
Pharm.D.
Pharmacist, Sterile and Non-Sterile Compounding
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
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
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
23
PHARMACIST PROFILES (continued)
Nicholas Diamanantopoulous
R.Ph.
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 Compounding
ISO 9001:2008 Quality Systems
Code of federal Regulations Part 21 cGMP Compliance
Research and Product Development
24
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
COMPOUNDED PREPARATIONS: Disclosure Between Parties
One 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].
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
(800) 854-7220
mcguffmedical.com
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
25
McGUFF MEETS NATIONAL AND INTERNATIONAL QUALITY STANDARDS
“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.
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
PHARMAC Y
COMPOUNDING
ACCREDITATION
BOARD
• California Board of Pharmacy
            - Pharmacy License number: PHY43950
• Drug Enforcement Administration
            License Number: BM6241777
• We are licensed in every state that requires licensing
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
26
2921 W. MacArthur Blvd. Suite 142, Santa Ana, CA 92704 tel 1-877-444-1133 fax 1-877-444-1155
www.mcguff.com
Dr. Berkson Requires
LIPOIC
ACID
Injection
To be compounded with the following minimum requirements:
• Raw material is manufactured in Europe and not in China.
• Formulation has no surfactants or organic solvents.
• Lipoic Acid Injection is potency tested using HighPressure liquid chromatography (HPLC) method at an FDA
registered lab.
McGuff Compounding Pharmacy meets or
exceeds Dr. Berkson’s requirements:
• 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 HighPressure liquid chromatography (HPLC) equipment at
an FDA registered lab.
• How supplied: Lipoic Acid Injection 40mg/mL 15mL
preservative-free vial.
See page 7 for details.
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
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
“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
(877) 444-1133 | www.mcguffpharmacy.com