Aps pharmacy new hcg formula?

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Defy Medical TRT clinic doctor
Ill go out on a limb and speculate that they're not being allowed to compound the exact same product as big pharma produces and thus alter it slightly. That's my informed guess.
 

KSPhD

Member
Weird combo. One advantage is it has no known toxicity issues despite crossing the blood brain barrier. Wonder what the rationale was....
 
May be partially the reason...who was it that started adding Anastrozole to their Cyp...its not Hallandale, but for the same reason I stated.
 

KennyT

Member
Great I just found this out today when I tried to refill my script. The don't make the 11000 IU HCG any longer at APS. Now my script is junk and I am almost out of HCG. I have a call into my Doctor but I don't know if he will go for the new mix. I would need 2 vials per month now because they only do 5000 IU HCG per vial now and I was getting the 11000 IU. Even at that i'm shorted 1000 IU. I'm not a happy camper. :(
 

KennyT

Member
I also found this


[FONT=&quot]What is L-Theanine?[/FONT]
[FONT=&quot] L-Theanine is an amino acid that is present in the tea plant and some mushrooms. The “L” is a scientific notation of its structure. It's makeup is related to L-Tryptophan, which is another amino acid that is a precursor to the neurotransmitter serotonin. Serotonin is a chemical manufactured by the body that controls mood balance, and is sometimes referred to as the “feel good” hormone. When the serotonin in your brain is at a perfect level, you are creative, relaxed, focused, and have great impulse control, which is typical of the perfect zen state of mind. On the other hand, if your levels of serotonin are low you may feel depressed, act impulsively, have a short attention span and have difficulty relaxing…the exact opposite of a zen mindset.[/FONT]
[FONT=&quot]Therefore, it is vital to maintain a good balance of serotonin, and L-theanine works wonders in this regard. L-theanine is responsible for the flavor of tea as well as the physical and mental effects that tea connoisseurs enjoy.[/FONT]
[FONT=&quot]L-Theanine lowers stress levels and relaxes your brain by increasing alpha wave activity. These are the waves that happen when you're alert, awake and relaxed. They also help you concentrate and boost creativity. The beautiful thing about L-Theanin is this: it allows you to be alert and focus while at the same time remaining calm without becoming sleep or drowsy.[/FONT]
[FONT=&quot]L-Theanine was isolated from green tea as a flavor component by Japanese scientists in 1949. It can pass the blood-brain barrier and has been shown to have neuroprotective abilities. Several Japanese studies have demonstrated that oral intake of L-Theanine can produce a feeling of relaxation and improved sleep quality, as well as reduced stress responses during stressful situations. Another Japanese study confirmed that L-theanine resulted in large increases in serotonin and/or dopeamine concentrations in the brain, particularly in the striatum, hypothalmus and hippocampus. The result? All of the “feel good” benefits mentioned above.[/FONT]
[FONT=&quot]L-Theanine also acts as a natural anxiety-fighting supplement. The at times maddening pace of 21st century life has many, if not most people constantly stressed-out, with frayed nerves. Medical professionals are quick to hand out anti-anxiety prescription drugs that may be effective, but may also come with serious side effects, not to mention the possibility of developing dependence on them.[/FONT]
[FONT=&quot]But instead of drugs, many folks find that tea is their favorite method of relaxing, due to tea's calming effect. And, as mentioned earlier, the main ingredient in tea that produces that calming effect is L-Theanine.
[/FONT]

[FONT=&quot]But that's not all of the benefits that L-Theanine delivers[/FONT]
[FONT=&quot] In the ever-increasing fast-pace society that is 21st century America, stress is a gigantic problem, and takes a terrible toll in many ways. According to The American Institute of Stress, there are numerous emotional and physical disorders that have been linked to stress including depression, anxiety, heart attacks, stroke, hypertension, immune system disturbances that increase susceptibility to infections, a host of viral linked disorders ranging from the common cold and herpes to AIDS and certain cancers, as well as autoimmune diseases like rheumatoid arthritis and multiple sclerosis…what a parade of horrors![/FONT]
[FONT=&quot]Knowing this, it's easy to see that if the only benefit regular doses of L-Theanine did was reduce stress, it would be well-worth your while to jump on it. But it does more than reduce stress…far more. Here are some of the other health benefits of this amazing amino acid:[/FONT]

  • Combating insomnia. Inability to get a good night's sleep is all-too-common for millions of Americans, and the problem seems to be getting worse. Stress, inactivity, sickness, medications, terrible sleep environment…take your pick. They all cause problems when trying to get to sleep. The effects of lack of sleep are devastating: more accidents, less cognitive ability, more ill-tempered people, less release of growth hormone and, for men, lower release of testosterone. Supplementing with L-Theanine levels out the brain waves, resulting in a relaxed body and a calm mind, but no drowsiness. This is exactly the type of relaxation prescribed by sleep researchers. Also, L-Theanine not only helps you fall asleep; as an added bonus, it can cause you to sleep better.
  • Balancing Brain Chemistry. Memory can be decimated by a number of things: aging, stress and depression are the three main culprits. Cortisol is known as “the stress hormone”, and when its levels are high, stress increases. But L-Theanine comes to the rescue, and has been shown to lower cortisol levels, which helps memory as well as other health benefits. Other stress hormones called glucocorticoids are activated by stress and depression. They also disrupt serotonin, dopamine, norepinephrine and other important brain chemicals. Theanine suppresses glucocorticoids, since it is one of the few supplements that has the ability to cross the blood-brain barrier.
  • Helps the liver perform its important functions. Research from Japan has shown that theanine is effective in combating the harmful effects of excessive alcohol on the liver. Here's why: alcohol morphs into a toxic chemical called acetaldehyde, which is similar to formaldehyde and is far more toxic than the alcohol itself. Theanine speeds up the break-down of acetaldehyde, which effectively blocks toxic free radicals. Glutathione has been called “The Master Anti-Oxidant”, since it plays such an important role in all aspects of good health. The liver deals with alcohol by calling on glutathione to suppress the damage alcohol causes. The problem? Too much alcohol too often causes the liver to weaken, with life-threatening consequences. Theanine helps fight this alcohol-induced loss of glutathione.
  • Blow-torch fat. Everyone wants to rid themselves of ugly, disease-producing blubber. Research has proven that green tea extract causes thermogenesis, which is the process of the body's heat production. Thermogenesis has been shown to help burn fat, and research has shown that the combination of caffeine and theanine in green tea helps prevent weight gain and fat accumulation.
  • Nerve protection. L-Theanine prevents damage to brain cells by blocking over-stimulation of the cells and also guards brain cells from damage when oxygen levels are low, which can prove life-saving in the event of a stroke. Additionally, it also makes new brain cells by stimulating the release of a protein required for nerve growth. Still another way that L-theanine offers nerve and brain protection is its ability to protect the body from excess glutamate, which is a natural neurotransmitter that allows signaling between nerves. This chemical can be poisonous to nerve tissue if the levels are not regulated. L-theanine has shown the ability offer the nerves of the brain protection from the insidious condition of excess glutamate.
  • A powerful anti-oxidant. L-Theanine works its magic in many ways. One of them is the protection it provides to the cardiovascular system by preventing oxidation of low-density lipoprotein, or LDL cholesterol, which is often referred to as “the bad cholesterol”. Research published in the July 2012 issue of the Journal of Nutritional Biochemistry states that L-Theanine protects the cardiovascular system by stimulating the production of nitric oxide, which causes blood vessel dilation in the lining of the arteries. This reduces blood pressure, and lowers the risk of a heart attack.
  • Lowering the startle response. Daily, we are subject to a continuing barrage of useless, trivial information: advertisements that insult our intelligence, chatter from others that we don't want or need to hear, phones, traffic sounds, etc. The list could go on and on. To prevent our brains from exploding (figuratively), we are equipped with something called sensorimotor gating, which scientists define as “neurological processes of filtering out redundant or unnecessary stimuli in the brain from all possible environmental stimuli.” To make this a bit more understandable, consider this: if we couldn't filter out anything, we would be helpless to do anything. Sensorimotor gating prevents the brain from becoming overloaded with irrelevant information, which allows us to focus on what we need to know, and on what we are doing. This ability of L-theanine to lower the startle response helps explain why it gives us more focus while staying calm. One definition of this process is that L-theanine “can help control the gates of awareness”.
[FONT=&quot]What is the correct dose of L-theanine?[/FONT]
[FONT=&quot] The typical dose of L-theanine is 100-200 mg once to twice a day. The good news is that L-theanine is well-tolerated by the vast majority of users and has no adverse effect on driving abilities, or other day-to-day activities. Still, as with all nootropics, the effects can vary, so as always, start slow and gauge your reactions.[/FONT]
[FONT=&quot]So there you have it. Granted, supplementing with L-theanine will not turn you into a zen master overnight. But it will deliver the benefits mentioned. Consider adding this safe, inexpensive supplement to your nootropics cabinet.
References[/FONT]

[FONT=&quot]Koda K, Ago Y, Kawasaki T, Hashimoto H, Baba A, Matsuda T. Galantamine and donepezil differently affect isolation rearing-induced deficits of prepulse inhibition in mice. Psychopharmacology (Berl) 2008 Feb;196(2):293?–?301.[/FONT]
[FONT=&quot]Ago Y. Beneficial effect of galantamine on sensory information-processing deficits. Yakugaku Zasshi 2010 Oct;130(10):1305?–?10.[/FONT]
[FONT=&quot]Ota M, Wakabayashi C, Matsuo J, Kinoshita Y, Hori H, Hattori K, Sasayama D, Teraishi T, Obu S, Ozawa H, Kunugi H. Effect of L-theanine on sensorimotor gating in healthy human subjects. Psychiatry Clin Neurosci. 2014 May;68(5):337-43.[/FONT]
[FONT=&quot]http://www.lef.org/Magazine/2006/1/report_theanine/Page-01[/FONT]
[FONT=&quot]http://www.medicalnewstoday.com/articles/232248.php[/FONT]
[FONT=&quot]Kobayashi, et al. Effects of L-theanine on the release of alpha-brain waves in human volunteers.[/FONT]
[FONT=&quot]Kimura et al. L-Theanine reduces psychological and physiological stress responses. Biol Psychol. 74 (1): 39-45 (2006)[/FONT]
[FONT=&quot]http://www.stress.org/stress-effects/[/FONT]
[FONT=&quot]http://en.wikipedia.org/wiki/Theanine[/FONT]
[FONT=&quot]http://en.wikipedia.org/wiki/Sensory_gating[/FONT]
 

Vince

Super Moderator
Great I just found this out today when I tried to refill my script. The don't make the 11000 IU HCG any longer at APS. Now my script is junk and I am almost out of HCG. I have a call into my Doctor but I don't know if he will go for the new mix. I would need 2 vials per month now because they only do 5000 IU HCG per vial now and I was getting the 11000 IU. Even at that i'm shorted 1000 IU. I'm not a happy camper. :(

Empower Pharmacy has 11000iu vials of HCG. That's what I use, I like the bigger vials, less mixing.
 

ScottM

New Member
Your sir are correct. This is affecting several compounding pharmacies.

The FDA guidance regarding this decision is attached or available for review on their website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf

Ill go out on a limb and speculate that they're not being allowed to compound the exact same product as big pharma produces and thus alter it slightly. That's my informed guess.

Cheers,
Scott
Telthera, LLC
 

ScottM

New Member
Thanks Nelson. In the interest of not switching gears on Maximus and posting a large bit, or hijacking a thread, I made a post on my own thread to respond to you and share more about Telthera for those curious.

https://www.excelmale.com/forum/showthread.php?10824-So-Happy-To-Be-Here&p=72910#post72910

In essence Telthera is the product of consultants, scientists, and physicians, built for the niche of TRT males who really want to take control of their Hormone Optimization. We only enroll a handful of patients at a time so that we can truly engage with them and manage their care on a personal level. I am not here to promote, so I'll keep it short, but Telthera aims to be the Uber to the TRT Taxi Cab.
 
Last edited by a moderator:
Compounded Drug Products ThatAre Essentially Copies of aCommercially Available Drug is draft guidance, not regulation (yet). In addition, this issue appears to be isolated to APS pharmacy as I work with multiple 503a and 503b pharmacies that do not have to change their formulary. If you closely read the FDA language it broadly allows for a pharmacy to compound a product that is commercially available as long as one of the following is changed, therefore making the final product not equal to what is commercially available:
1) Strength
2) Excipients/inactive ingredients
3) Dosage form (ie offering a sublingual as opposed to tablet)

Most compounders offer medications that have more than one change.

I suspect there is more to the story regarding any pharmacy who is currently stating that they can no longer compound a product that is still being dispensed by many other compounding pharmacies, including FDA registered 503b pharmacies (if the FDA was enforcing this then it would certainly have been enforced on 503bs, which it has not).
 
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