Lobo Tejas Laboratories, owned by Gary Osborn, RPh, CCN, is operated by his medical staff at the Texas Institute of Functional Medicines.
Lobo Tejas Laboratories was started in response to the federal government's action against a pharmacist friend of mine in California. He was accused of compounding a non-sterile injection with the resulting death of patients. He had no way of proving the sterility of his compounds in this case, as he only did in-house incubator controls. The rest is history in California!
I had been involved in a similar matter years ago in the case of Adrenal Cortex injection, but because I had outside lab testing on the sterility of every batch, I was exonerated from the case, and the appropriate person was found guilty. I took note of this!
As a result of this I felt it was time to give back to my fellow sterile compounders and protect myself as I saw the ever increasing involvement by non-pharmacy government agencies in matters of this sort with deleterious outcomes. I developed a new company to test for sterility and pyrogencity for compounders, including myself, called Lobo Tejas Laboratories.
California has raised the bar for both resident pharmacists and non-resident pharmacists in the sterile compounding area, effective July 1, 2003. We suspect many other states will follow suit in the testing requirements for sterility and pyrogens. Lobo Tejas Labs is currently working with many of the California sterile compounders in helping them qualify for their own state's requirements successfully. We are now working with several other non-resident pharmacies that were shipping sterile compounded products into California. We can supply you with the web sites for all the requirements, but here is a summarization from our legal department.
The USP chapter 797 outlines clearly what is required of all US pharmacies wishing to compound sterile products (CSP's). Here is a very brief description of some, not all, of the items of highest priority for pharmacies to incorporate.
* All compounded products must maintain their full potency until the expiration date. The date at which potency loss of 10% or more is reached, becomes the "beyond-use" date determined through direct analytical testing.
* The facility must maintain a log and segregation of the various CSP's according to their risk levels.
* High risk CSP's have to be terminally steam sterilized, autoclaved, or filtered with a nominal porosity no larger than 1.2 microns.
* The air quality present in the sterile room must be ISO Class 5 or superior.
* All technicians must be certified and adhere to the highest of standards of procedures for CSP and pass a semi-annual media-fill test procedure.
* CSP's (high risk primarily, but others as well), must be terminally tested and determined to be sterile and pyrogen-free.
* CSP's must be produced utilizing a laminar airflow workbench within an ISO Class 5 room and should have a buffer room prior to one entering the laminar airflow area.
These standards should be of highest priority to a compounding pharmacy. Lobo Tejas Laboratories can help you meet all of the regulations set forth by the USP.
Professional Lab Services
The guidelines used by our lab that performs our sterility and pyrogen testing are as follows:
Sterility Testing
Pyrogen Testing
Unique New Lab Panels Now Available to Physicians
A unique service you can now offer to your patients: The most advanced cancer screening lab test available today from Japan. It has not been offered in the states due to price and logistics of shipping samples.
We have expanded to offer unique lab tests available here only. We act as a high-tech collecting site for physicians to ship their samples to, where they will be handled and stored in our medical clinic by our nursing staff, who are used to handling highly sensitive lab tests. When the appropriate time comes to ship internationally, the samples are sent to arrive within 24 hours.
New Primary Cancer Prevention Methods of Risk Assessment Using a Tumor Marker Combination Assay
Enhancement of Immunosurveillance In Cancer Patients
Summary of Dr. Kobayshi's Research
VASCULAR INFLAMMATORY MARKERS ARE EVOLVING RAPIDLY IN CARDIOVASCULAR DISEASE
As chelation is taking tremendous leaps forward, cardiovascular disease is now being addressed in a very different way. It will require the chelating physician to complete more lab testing. Vascular inflammation reduction is and has been the key objective and needs to be measured. Exciting new instruments of measurement are appearing on the scene, but we have found that bio-chemical measurements of two primary markers are less expensive, easy to do and insurance coded. These are Highly Sensitive C Reactive Protein and Fibrinogen. The NEJM lists HSCRxP as the number-one marker in CVD and high plasma fibrinogen is useful in predicting coronary heart disease. Lobo Tejas Laboratories has made special arrangements with a national blood lab to design various panels and will be a collection center for these panels. In exchange, we receive tremendously lowered pricing which we will be able to pass on to you.
Please contact us if there are any labs you would like us to develop, or for more information regarding the cancer screeing tests or HSCRxP testing at 972-759-4929 or by e-mail.
Other services that we are introducing to our fellow compounders are raw materials for compounding. We have a sister facility, SpectraPharm, that is fully FDA licensed in many areas including re-labeling and re-packaging of bulk raw materials. Being a business minded pharmacy, we want to share our fabulous prices on some of the raw materials we buy in large quantities with you.
The following are the materials that we have available. Certificates of Analysis are available on all materials listed below. Weighing will be conducted by Certified Pharmacy Technicians on electronic balances for 100% accuracy. Please compare our prices to what you are currently paying, then call us at 972-702-8434.
Lab Sterility Aids
Settling Plates- A Tryptic Soy Agar plate that can be placed in your sterile compounding area to let airborne pathogens "settle" onto it. It is very simple to use: First, empty the room completely. Inside the hood, set plate uncapped inside for no longer than one hour. Outside the hood, set the plate down uncapped for no longer than two hours. The plate must be placed where the airflow over plate does not first contact humans.
SDA Concentrate- A very unique product developed 12 years ago which consists of a dual quaternary ammonium compound, complexed with tributyl tin that has allowed us to literally have no contaminations in the lab and in the pharmacy when used on inanimate objects, such as IV hoods, etc.
Sterility Swabs- An easy way of testing the surface of a compounding area to assure sterility. We suggest performing a monthly swabbing of the surfaces on the inside of the IV hood.
Identification of test vials:
We, in the interest of total anonymity, assign you an account code and allow you to submit your test vials to us with a code on the label, as long as you know what it is, we don't need to know. The laboratory will then have no way of knowing who the customer is.
Recently, I have contracted with a top Ph.D. of Infectious Diseases to help us answer the questions posed by compounders when they have compounding sterility problems. He is thoroughly trained in sterility testing, diseases, and consults for several large national laboratories.
Gary believes in providing meaningful and cost effective lab testing to his patients at the Texas Institute of Functional Medicines, his customers at ApothéCure and his fellow sterile compounders. He has contact with many top-notch labs and suppliers and is able to introduce a one-stop shopping experience to the thousands of physicians and pharmacists he deals with nationally and internationally. Minerals Neural Therapy Pain Management Prolotherapy Vitamins Bookstore Legal Issues Medical Conference New Customer Doctors Patients Homepage Combinations Glandulars Hard To Find Injectables Hormones Osmolarity Table IV Equipment Large Volume Mesotherapy Doctors Patients Homepage American Academy of Craniofacial Pain Gary Osborn Doctor Medical Clinic Store SpectraPharm Dallas Texas USA Injectables Doctors Patients Homepage Heavy Metal Detox Neurological Therapies Opthalmic Pain Management Prolotherapy Sexual Function Sleep Aids Sports Doctors Patients Homepage ACAM ASAM A4M AACL AAEM NTMP AACP IOAMT MD Aesthetic Formulation Treatment Protocol Products Pharmacy Compounding Doctors Patients Homepage Mole Removal Radiesse Restylane Sclerotherapy Sculptra Ambulatory Vein Removal Wrinkle Fillers Auto Immune Disease Aesthetic Functional Medicine Progressive Clinic Mercury Toxic Hormones Synthetic Bio Identical Therapy Neural Osteoporosis Vasectomy Erectile Dysfunction Mesotherapy Aesthetic Functional Medicine Progressive Clinic Treatment Protocols Research Development Detoxification Comprehensive Therapy Serious Health Surgery Surgical Therapies Aesthetic Functional Medicine Progressive Clinic Prolotherapy UVB Ozone Cellulite Health Medicine Food Allergies Heart Heavy Metal Botox Face Peels Fillers Transfers Fat Aesthetic Functional Medicine Progressive Clinic Non Surgical Facelift Lip Enhancment Breast Implants Restylane Radiesse Sclerotherapy Sculptra Wrinkles Fat Liposuction Aesthetic Functional Medicine Progressive Clinic