It was my pleasure to recently get to interview Shaun Noorian of Empower Pharmacy, who runs one of the largest national compounding pharmacies here in the U.S. For those unfamiliar, compounding pharmacies can be a life (and money) saver for many men and are widely used by most doctors and hospitals to cover a wide range of pharmaceuticals - not just HRT and TRT-related medications. I personally have used compounded testosterone for several years as have many on the Peak Testosterone Forum. As you'll see below, Shaun discusses not just compounded testosterone creams, but compounded injectable testosterone, compounded Cialis, other erectile dysfunction formulations and much more in the must-read interview:
GUEST INTERVIEWER: Shaun Noorian of Empower Pharmacy.
Q. I understand you're a fellow engineer. So can you tell us how you ended up in the business of compound pharmacy? And, of course, I'd be interested to know if your engineering background helped you?
Ever since I was a kid I've been fixing, building and racing cars. I went to engineering school to study mechanical engineering with an emphasis on automotive engineering, so I could get a job in the automotive industry. When I graduated in 2007 the automotive industry wasn't hiring due to the recession, so I did what most engineers in Texas do: work for an oil & gas company. I was happy to get a job working for Schlumberger as a field engineer for a hydraulic fracturing crew. It was back-breaking work, so naturally I hemorrhaged three of my lower vertebrae on the job and could no longer work.
Going through rehab I had my blood tested and one of my doctors noticed that I had the testosterone level of an 80 year old. Looking back, this was probably one of the factors that led to my injury as I had very little muscle mass to support the heavy objects I was lifting as an oil field engineer. I was diagnosed with secondary hypogonadism caused by a pituitary disorder that prevents my body from creating Luteinizing Hormone, the hormone responsible for signaling the testes to create testosterone.
I was put on testosterone replacement therapy (Clomiphene, Testosterone Cypionate, HCG, Tamoxifen) and the results were life changing. I immediately experienced many of the benefits of TRT. I gained 10 lbs of muscle without even working out and my libido, motivation, ambition and energy increased to levels I never knew existed. Understandingly, I became passionate about TRT and read up as much as I could on the subject. For readers interested in learning about TRT I recommend Testosterone: A Man s Guide by Nelson Vergel, The Testosterone Syndrome by Dr Eugene Shippen, Testosterone Replacement Therapy: A Recipe for Success by Dr John Crisler and The Definitive Testosterone Replacement Therapy Manual by Jay Campbell.
Part of that research led me to learn about the medications I was taking. I was getting my TRT drugs from a local compounding pharmacy and noticed the quality and service were not up to the standards I believed they should have been. With my training in manufacturing and quality control I knew I could do better, so I began my journey of learning about compounding. I attended all the conferences compounding pharmacists attend, read numerous books on compounding and took several live training courses as well. Once I believed I was ready I opened my pharmacy in 2009 with a single pharmacist on staff and myself as the pharmacy technician.
By applying my engineering background to creating quality, economical compounded drugs with the customer service I would want to experience as a patient we've been able to become one of the largest compounding pharmacies in the nation.
Q. I was on compounded testosterone for years, because Androgel simply did not work for me, i.e. it did not raise my testosterone. Can you explain some of the other reasons that a man might want to use a compounded testosterone cream instead of just going with a branded product?
Androgel is 1.62% Testosterone by weight. Compounded Testosterone Cream can be up to 20% Testosterone by weight. While both of these branded and compounded products allow testosterone to be dosed transdermally we recommend transdermal creams over gels for several reasons:
1. Creams have longer beyond use dates than gels have. Gels are made up primarily of alcohol and water. The water causes accelerated degradation through hydrolysis, which is why many aqueous formulations have much shorter beyond use dates compared to non-aqueous drugs.
2. Creams offer superior penetration compared to gels. We use a hypoallergenic cream base made specifically for hormones. This base offers a much higher penetration (40-50%) compared to the 10% penetration of most water based gels. The creams we use also have undergone validated transdermal penetration studies proving their efficacy. Since 5 times more drug is being delivered into circulation by using a transdermal cream vs a gel there is less drug wasted.
3. Creams moisten the skin while water/alcohol gels dry it out.
4. You can accommodate higher active ingredient loads with creams vs gels as most hormones (especially testosterone, estrogen and progesterone) are not water soluble and require a lipophillic vehicle.
5. Patients whose insurance doesn t cover branded transdermal testosterone products have to pay out of pocket $300-$400 dollars every month. Compounded transdermal creams are about 1/8th the cost, so there are significant cost savings.
NOTE: You can check out Shaun's site here: Empower Pharmacy.
Q. You offer testosterone injectables as well, correct? Can you explain which esters you offer and some of the typical reasons a doctor may prescribe one over the other?
We offer the 3 most popular forms of injectable testosterone: Testosterone Cypionate, Testosterone Enanthate and Testosterone Propionate.
The pharmacokinetics and pharmacodynamics of Testosterone Cypionate and Testosterone Enanthate are practically identical. What primarily differentiates them are the vehicles they are compounded in.
Each mL of Testosterone Cypionate 200mg/mL contains: Testosterone Cypionate 200 mg, Benzyl Benzoate 20%, Benzyl Alcohol 1% as preservative, in Grapeseed Oil.
Each mL of Testosterone Enanthate contains: Testosterone Enanthate 200 mg, Chlorobutanol 5 mg as preservative, in Grapeseed Oil.
As you can see Testosterone Cypionate requires 20% Benzyl Benzoate as a solubizer to get the cypionate ester in solution and uses 1% Benzyl Alcohol as a preservative. Testosterone Enanthate does not need a solubizer to go into solution and uses 0.5% Chlorobutanol as a preservative.
Since they both have the same half life the advantage of using one or the other is typically patient specific. For patients that are sensitive to Benzyl Benzoate or Benzyl Alcohol Testosterone Enanthate is recommended. For patients that are sensitive to Chlorobutanol Testosterone Cypionate is recommended.
Since both Testosterone Cypionate and Testosterone Enanthate have a half life of 8 days it is most commonly prescribed as a weekly intramuscular dose, so it is difficult for a patient to attain stable testosterone levels during their therapy. For this reason some prescribers administer Testosterone Propionate alongside Testosterone Cypionate/Enanthate as the Propionate ester has a half life of 2 days, which allows patients to experience more stable testosterone levels once much of the Testosterone Cypionate/Enanthate has been used up by the body, but before the next weekly injection is due. Many prescribers are switching from weekly to bi-weekly injections of Testsoterone Cypionate/Enanthate to keep serum testosterone levels stable enough, so Testosterone Propionate is rarely prescribed.
Q. I know there is a lot of interest in HCG out there, to help overcome testicular shrinkage, HPT shutdown and loss of fertility while on TRT. How can a man get HCG from your pharmacy? How is it shipped and then prepared for men who are interested?
Like any other medication we dispense all we need is a prescription from the patient's physician. Once we receive the prescription we'll give the patient a call to counsel them on the use of the medication, make sure they have all the supplies they'll need and verify their shipping address. This process only takes a few minutes, so most of our prescriptions ship out within 24 hours.
Since HCG is temperature sensitive and has a relatively short beyond use date once it is in an aqueous solution we lyophilize (freeze dry) our formulations. All our Patient Orders come with syringes, alcohol pads, and reconstitution kits included free of charge. The reconstitution kit includes bacteriostatic water, mixing instruction sheets, along with directions on the amount of diluent to reconstitute with. We also provide injection instructions to ensure the patient is aware of the correct techniques necessary to self administer subcutaneous and intramuscular injections.
Q. Many men on the Peak Testosterone Forum are using testosterone cypionate? How do you usually ship that, i.e. what sized vial(s)?
Our compounded Testosterone Cypionate is made in Grapeseed Oil instead of Cottonseed Oil, which is the base oil used in commercial formulations. Many prescribers prefer Grapeseed over Cottonseed because it is thinner and less painful to inject. We compound Testosterone Cypionate in multiple strengths (50, 100, 150 and 200 mg/mL). Since testosterone is a Schedule III Controlled Substance it can only be written for a maximum of 3-6 months at a time depending on your state. Since the larger 10mL vials produce a regulatory risk for many of our patients and providers we offer Testosterone Cypionate in 2.5mL and 5mL vials. If we receive a prescription for a 10mL vial and the dose is high enough to last less than 3-6 months we simply give two 5mL vials.
Q. How do you make sure that what you ship out is safe and effective?
Making a testosterone cream requires standard procedures such as being masked, gloved and gowned. However, making an injectable testosterone or HCG is a different matter. The making of drugs to be injected into humans is probably the most regulated industry in the world. The amount of nuance that goes into the production of a sterile dosage form can be overwhelming for many compounders, which is why only a small percentage of us choose to do it. To get an idea of what it takes to be able to compound a sterile drug I think it's a good idea to walk someone through the laborious process:
First, we enter the segregated area of our facility that contains our pressurized cleanroom, which is certified biannually by a third party specialist. Pressure, temperature, humidity, and particle counts are monitored and recorded in real time to ensure the cleanroom is functioning within requirements. Before entering the cleanroom we don sterile hairnets, face masks and booties. We then enter the gowning airlock, where we "scrub in" just like a surgeon does before surgery. Once our hands and arms are clean we don sterile coveralls, boots and goggles followed by sterile gloves. At this point we are fully encapsulated in our sterile bunny suits and ready to enter the next room.
In our formulation room we store all our supplies and USP quality chemicals used in the compounding process. Chemicals are weighed inside of a Powder Hood using a scale that is integrated with our computer systems to prevent errors in weighing from occurring. Once all our ingredients are weighed out we add them into a sterile, depyrogenated mixing vessel and proceed to dissolving the active and inactive ingredients into solution. Once our solution is mixed we filter it through a 0.2 micron pharmaceutical grade filter into a sterile IV bag.
This bag is then taken into another, cleaner room, where it is brought into an ISO 5 Biological Safety Cabinet for filling. The bag is hooked up to an automated filling device and a calibrated volume of liquid is dispensed into sterile vials, which are then stoppered, capped and crimped under aseptic conditions. The vials then undergo quality inspection, are labeled, and sent off for third party sterility, endotoxin, potency, pH and particulate testing. The batch is then stored under quarantine until we receive passing sterility results showing the compound is safe to be dispensed.
Every aspect of the production process is recorded and validated by a sterile-licensed pharmacist. We are also inspected by several state and federal agencies several times a year to ensure our facilities and personnel are compliant. All of these controls and regulations give our patients and practitioners the confidence that the compounds they are receiving are safe and effective.
Q. I know that TRT does not have to be expensive. How do you lower your costs to make your testosterone products affordable for the typical working or middle class man out there?
Before I opened Empower Pharmacy I knew firsthand how expensive testosterone replacement therapy could be. My primary goal of opening this pharmacy was to provide quality, affordable compounds. Since we specialize in testosterone related compounds we are able to purchase these bulk chemicals in large quantities at a discounted price, which allows us to pass the savings on to our patients. We also don't have the multi-billion dollar overhead of a large pharmaceutical company, so our costs to produce drugs are lower in most cases.
Q. Am I correct in assuming that the majority of doctors have not used compounded injectable testosterone (or HCG) with their patients before? Assuming that's true, how can one of the men on Peak Testosterone get his physician up to speed? Do you have any fact sheets / links, etc. that the patient could refer his doctor to?
You are correct. Most prescribers are unaware that compounded testosterone and HCG exist. Typically, only the most experienced doctors that specialize in TRT are aware of the benefits a compounding pharmacy can offer to their patients that pharmaceutical companies cannot. We don't have the resources or marketing teams a big pharmaceutical company has, so it isn't feasible to reach a fraction of a percent of prescribers to educate them.
Realizing this we've created some of the best peer referenced web pages on each of our compounds that patients can print out and bring to their doctors. I'm very proud to say that we've been able to expand primarily through the word of mouth of our loyal patients.
Q. So you can actually ship your compounded medications to all 50 states, right? Can you explain why a physician would order a compounded medication from you across state lines and some of the more important requirements that you have to meet in order to be able to do that?
Every pharmacy is governed by the rules of its own State Board of Pharmacy. If a pharmacy wants to ship drugs into a neighboring state that pharmacy must first meet all the regulations and become licensed in that non-resident state. Some states require the pharmacy's pharmacist-in-charge to pass that state's pharmacist exam before allowing the pharmacy to apply for a pharmacy license. Some states require separate sterile compounding licenses. Other states actually require the pharmacy to pay an inspector to fly in and inspect your pharmacy before issuing a license. We recently became licensed in all 50 states. This feat took us over 4 years to accomplish. In total, our pharmacy has over 110 different state and federal licenses to be able to legally ship our compounds nationwide and that number grows every month as new state and federal regulations come in effect.
There aren't that many compounding pharmacies that specialize in both sterile and non-sterile testosterone related drugs, so most doctors don't have a local pharmacy they can send their patients to. Most of our doctors and patients choose to send their prescriptions to us because of our reputation in the industry. I still can't believe the amount of prescribers practicing thousands of miles away that hear about us through their patients and colleagues.
Q. When can a doctor write a prescription for compounded versions of Viagra and Cialis? What medium do you put it in?
All compounded medications are made at the request of a prescribing practitioner due to a patient specific medical need and the prescriber's belief that the preparation will produce a clinically significant therapeutic response compared to a commercial product.
For example, some practitioners prescribe PDE5 Inhibitors to be taken sublingually vs orally due to the sublingual dosage form allowing the active ingredient to be absorbed directly into the blood stream bypassing the patient's hepatic system. It's been shown that plasma clearance of sildenafil may be decreased in patients with liver disease, resulting in drug accumulation. In volunteers with cirrhosis (Child-Pugh A and B), the peak plasma concentration (Cmax) increased by 47% and the area under the concentration-time curve (AUC) increased by 84% compared with age-matched volunteers without liver disease. Therapy with sildenafil should be administered cautiously in patients with significantly impaired hepatic function. (Source: Product Information. Viagra (sildenafil)." Pfizer US Pharmaceuticals, New York, NY)
Another example: Some practitioners choose to prescribe troches vs the commercially available tablets due to the below non-active ingredients that a patient is sensitive or allergic to, the most common one being lactose.
In comparison our compounded troches contain:
Based off the above or other reasons many of these practitioners use their professional experience to determine whether or not a compound may be beneficial based on their patient's clinical history.
Q. Business has been growing rapidly for Empower Pharmacy. What has fueled that growth?
First and foremost, our staff of professional pharmacists, technicians and pharmaceutical engineers works diligently to ensure our patients are given quality medications and the time and training needed to properly administer them. By concentrating on our service, quality and affordable pricing we've distinguished ourselves from many other compounders.
Another factor that has attributed to our growth is the shrinking number of our competitors. Ever since the NECC tragedy happened in late 2012, which killed 75 and injured over 700 patients, state and federal agencies have been cracking down on non-compliant compounding pharmacies. To date hundreds of compounders have been either shut down or closed their doors due to these new stringent laws. Since we have always exceeded many of these regulations from day one we didn't have to worry about our long term viability.
Q. I've seen pictures of your new facility under construction - it's impressive! What prompted you to build this new facility?
A few months after the NECC tragedy occurred Congress passed new laws giving the FDA the power to regulate sterile compounding pharmacies where before only the individual State Boards of Pharmacy had this power. These new laws will require compounding pharmacies that introduce sterile compounded drugs into interstate commerce to meet cGMP regulations (the same regulations big pharma uses to manufacture drugs) and register with the FDA. Since we want to continue to provide the highest quality compounds to our patients and practitioners this investment will solidify our ability to exist in this industry for many years to come.
Q. Many of us have been following the new set of controversial USP regulations (795, 797 and 800) that the FDA basically interprets and enforces in response to the DQSA law that was passed in Nov 2013. What is your take on these measures and how will they affect your operations in order to meet the new demands?
Our new facility was built from scratch to be able to meet cGMP requirements. I believe these stringent regulations will force the bad apples to go out of business and reward the compounders that are willing to invest in making compounds the right way.
Q. You elected to follow the FDA's GMP guidelines, correct? What does this mean and can you explain why it requires the most stringent requirements?
Pharmacies have been traditionally governed by United States Pharmacopeia (USP) regulations for over a hundred years, while large scale manufacturers have been governed by the FDA's current Good Manufacturing Practices (cGMP).
cGMPs are much more stringent than USP regulations. For example, under cGMPs cleanrooms must be monitored in real time for pressure, humidity, temperature and particulate counts. If any of these variables goes out of its acceptable range alarms must go off and the issue must be investigated and remediated before manufacturing can resume. In contrast USP only requires manually logging a daily temperature, pressure and humidity value.
cGMPs also require cleanroom personnel to change out of their street cloths and into washed scrubs before entering a cleanroom. Once in a cGMP cleanroom only sterile coveralls, boots, face masks and goggles are allowed. Not a single square inch of skin can be exposed. USP neither requires cleanroom personnel to change out of street cloths, don sterile garbing, or cover their facial skin while making sterile drugs.
These are just two examples out of hundreds of differences between cGMP and USP regulations. The FDA requires these strict regulations to protect the US public. While a tainted batch of drugs produced out of a traditional compounding pharmacy would only affect a limited number of patients, drugs produced out of manufacturing facilities have the potential to harm thousands of patients, which is why the extra safeguards are required.
Q. So what other kinds of products/medications does your compounding pharmacy offer in the way of hormone replacement, anti-aging and erectile dysfunction treatments?
When it comes to men's health we see many prescriptions related to erectile dysfunction, testosterone replacement, hair loss, and infertility. I'll start off by talking about testosterone replacement therapy (TRT).
The most commonly prescribed medications for TRT are injectable versions of testosterone such as Testosterone Cypionate, Testosterone Enanthate, and Testosterone Propionate. Then there are transdermal versions of testosterone, like Testosterone Cream, which can be rubbed onto your skin and absorbed topically, and then there are less popular dosage forms such as pellets and oral pills.
Of course, with any therapy there can be side effects related to that therapy. Some patients get side effects such as accelerated hair loss, breast tenderness, fluid retention, lack of libido or acne. We have other products to treat those. For hair loss we make a high strength Minoxidil/Azelaic Acid and Latanoprost topical solution.
Of course, a lot of people are on TRT because they've been diagnosed with erectile dysfunction. While some men respond well to oral ED treatments such as Viagra or Cialis, others do not or they have uncomfortable or even dangerous side effects. In those cases custom compounded medications can often be used successfully to treat ED.
There are a several different medications used to treat ED and one of the great things about compounders is we can make extremely efficacious versions of ED medications for patients where traditional medications such as Viagra, Cialis, or Levitra are contraindicated due to allergies or a patient taking nitrates or simply them not working anymore because the patient has advanced ED.
So, for those patients, we're able to compound an injectable erectile dysfunction medication called Trimix. Trimix is a combination of three different prescription medications: papaverine, phentolamine, and prostaglandin that are injected intracavernously into the side of the penis. Trimix has been proven through numerous clinical studies to be one of the most effective medications available for achieving erections especially in populations where oral medications no longer work.
The side effect profile of Trimix is also reasonable when properly dosed as its effects are primarily local since it s injected directly into the site where it s needed, whereas other oral medications must become systemic affecting your entire body before they can reach the place where you want them to work.
We also get a lot of requests from patients asking for buccal or sublingual versions of Sildenafil and Tadalafil, where the patient can put a troche in the side of their cheek or underneath their tongue and have the medication absorbed directly into their bloodstream compared to an oral version, which doesn't enter the bloodstream until it is processed through the hepatic system (liver), which can take up to 30 minutes.
We have human growth hormone related products for patients that are diagnosed with Adult Growth Hormone Deficiency. We see a lot of patients that are prescribed Sermorelin, GHRP-2 and GHRP-6, which are growth hormones secretagogues. Secretagogues allow patients to create and release their own growth hormone instead of the traditional way of introducing exogenous forms of the hormone.
There are several advantages to using secretagogues vs exogenous HGH. One is cost. Growth hormone secretagogues are a fraction the cost of HGH. Another advantage is that secretagogues prevent your pituitary from lowering its natural growth hormone production due to inhibitory negative feedback. Secretagogues also give the benefit of making it difficult for patients to overdose or attain supraphysiologic levels of growth hormone as their pituitary gland can only produce and secrete a finite amount of growth hormone no matter how much it s signaled. Finally, and arguably most importantly, many doctors are more comfortable prescribing secretagogues because the FDA has not banned their off label use like they have with HGH.
We also see a lot of prescriptions for HCG from urologists as well as doctors interested in preventing the suppression of their patient s natural testosterone production while on TRT. HCG is the hormone that is secreted by pregnant women and in men, it mimics the hormone, Luteinizing Hormone, which is the primary hormone that our pituitary gland produces to tell our testes in turn to produce testosterone.
We all have a negative feedback mechanism in our bodies that prevents us from overproducing too much testosterone when our body senses there is too much in our system and to produce more testosterone when there is too little. Doctors use HCG to not only prevent testicular atrophy in patients on TRT, but also to prevent the resultant decrease in their own natural testosterone production when on an exogenous form of testosterone is introduced.
It's also used in male patients that are interested in retaining their fertility while on TRT. We see fertility patients taking HCG anywhere from 500 IUs all the way to 3,000 IUs every other day to prevent testicular atrophy and keep their testicles producing sperm and testosterone.