U.S.P. Best Use Date Regulations Will Thwart Compounded Prescriptions
For years the pharmaceutical industry has complained about compounding pharmacies, questioning the safety and effectiveness of compounded medications. The Food and Drug Administration ratcheted up the requirements compounding pharmacies were obligated to follow, including special sterile manufacturing facilities and drug testing procedures. The standard for manufacturing a sterile injectable drug was so onerous that a majority of compounding pharmacies opted to no longer produce injections. Requirements for non-sterile drugs, oral medications as well as creams and gels, were not nearly as cumbersome. Compounding pharmacies agreed to abide by FDA regulations and remained productive in compounding bio-identical hormone creams as well as other drugs. Very few compounding pharmacies continue to manufacture sterile injectable drugs—however, since pharmaceutical manufacturers have declined to produce injectable chelation, B vitamins, certain minerals, and other drugs, compounding pharmacies have effectively become the only manufacturers of such injectables.
Over the course of the past few years the U.S. Pharmacopeia (U.S.P.) has decided to reset the standards for compounded drugs, both sterile and non-sterile. The U.S.P. believes that compounded medications have a limited shelf life and pose a safety risk. Because compounded prescriptions are not produced in the same manner as pharmaceuticals, it is believed that the compounded drug has a high likelihood of adulteration, bacterial/fungal contamination, and improper dosing. To ensure that the product has the least likelihood of microbial growth, the U.S.P. wants to limit product “best use date” (B.U.D.) to as little as 30 days and as long as 180 days. For much compounded prescriptions that will be produced with the least rigorous requirements, the 30-day B.U.D. would apply. Longer B.U.D. for compounded prescriptions will require unusual preserving techniques, including not just refrigeration, but freezing. The longest B.U.D. would be reserved for products that are “autoclaved” like surgical instruments. Such a process would disrupt the drug’s chemical and physical properties as well as adulterate the drug via decomposition of the plastic vial. The U.S.P. does permit the compounding pharmacy to escape these sterility procedures if the compound were to undergo very specialized testing, a process that would be unrealistically expensive if required for every compounded prescription. It is ridiculous to think that a compounded prescription of limited production would need $30,000 of testing done to secure a longer B.U.D.
The U.S.P. is accepting comments regarding their new regulations. It behooves all practitioners who prescribe compounded prescriptions to submit their comments to the U.S.P. To learn more about the regulations go to compounding.com, the website of the Alliance for Pharmacy Compounding. If the U.S.P. regulations go into effect, there will be an immediate effect on your practice. Patients will face the need to get a new prescription monthly for their compounded prescription and the price for the prescription will increase dramatically. Doctors who provide injectables to patients or administer intravenous infusions will find their injectable supply will be much more limited and the pricing for injectables will skyrocket. With the compounding requirements being so onerous certain compounded prescriptions will become unavailable. Some pharmacies will not want to deal with the new regulations and may close shop. For compounding pharmacies to meet all the regulatory requirements, delivery of prescriptions will take longer or go unfulfilled.
Remember that the Food and Drug Administration is still unhappy with the prescribing of bio-identical hormones. The new regulatory apparatus that will be established by the U.S.P. will become additional fodder for the FDA to harass pharmacies, doctors, and patients. Nothing is more annoying than the FDA recalling a prescribed compounded prescription.
Please act now. Ask your patients to write a story about how their injectable B12 or Bi-Est cream is being threatened, jeopardizing their health.
Make Comments to:
1. “795” (Non-Sterile Compounded Prescriptions)
https://usp.az1.qualtrics.com/jfe/form/SV_3OBK7VUbvver6zs
2. “797”(Sterile Compounded Prescriptions):
https://usp.az1.qualtrics.com/jfe/form/SV_81VZpnzjwcQJlZA
Cover Article: Thomas Levy, MD, JD, on Canceling the Spike Protein
Readers of the Townsend Letter are familiar with Dr. Thomas Levy’s writings, which have focused on the powerful effect of ascorbic acid on controlling infectious disease. The author of 13 books, Levy is board certified in cardiology and is admitted to the bar in Colorado and Washington, D.C. His most recent book, Rapid Virus Recovery, is an e-book available in English and in Spanish, at www.rvr.medfoxpub.com. Levy was honored by induction in the Orthomolecular Medicine Hall of Fame in 2016. Dr. Levy’s work focuses on the role that focal scurvy plays in all disease states, causing intracellular oxidative stress, most of which is reversed by administration of ascorbic acid and other anti-oxidants. In particular, Levy’s work has established a cause-and-effect relationship between infections in the mouth and the development of heart attacks.
In this month’s cover article Levy demonstrates with dark field microscopy that individuals vaccinated with the mRNA COVID-19 vaccines and non-mRNA vaccines develop severe rouleaux formation present for days and weeks after vaccination. The dark field microscopy also demonstrates that the rouleaux formation of red blood cells reverses entirely after intravenous administration of ascorbic acid as well as autohemotherapy with ozone. Equally remarkable is the persistent presence of d-Dimer in individuals post-vaccination. Remarkably d-Dimer is often present when other inflammatory and coagulation markers, such as C-reactive protein as well as fibrinogen, are absent. Levy makes the case that the spike protein is probably responsible for the d-Dimer persistence as well as the rouleaux formation. He argues that much of the damage that is possible by COVID-19 vaccination can be offset by administration of high doses of intravenous or oral ascorbic acid as well as the use of other antioxidants. In addition, Levy posits that long-haul COVID-19 is likely the result of ongoing spike protein activity, which can be assessed easily by measuring d-Dimer and studying the dark field microscopy for rouleaux. He would argue that the same treatment to counter and prevent post-vaccination adverse effects would be effective for managing long-haul COVID-19.
Sarah Lobisco, ND, on How the Power of Belief and Hope Can Heal
When we examine a double-blind randomized trial we recognize the power associated with a treatment demonstrating a dramatic improvement compared to a control. The control, a placebo, is assumed to have no benefit composed of an inert substance if given by mouth, saline by injection. Yet, it is impressive, at least from my perspective, that placebos frequently yield therapeutic benefit in the study. When the placebo benefit matches the tested therapy, the treatment is considered to be inefficacious, and the conclusion is that the drug failed to prove itself. Still why should an innocuous bit of sugar or saline cause a therapeutic effect at all?
The answer lies in the belief that the treatment is effective. It is nearly impossible to be involved in a clinical trial and to remain emotionally and mentally impartial. One is expending time and energy, obligated to undergo testing and imaging, and hoping that there will be a symptomatic change. The expectation is that one will show improvement. That hope engendered while unknowingly using a placebo creates major cognitive and physiologic changes; the more one is invested in the belief that the tested treatment will bear fruit, the more likely the placebo is to cause symptomatic change. The opposite effect, a belief that a treatment will not work, the so-called nocebo effect, is also remarkable especially if the study is conducted to disprove the benefit of a treatment. In such studies there is the belief by the investigator that the treatment is ineffective, and that belief system is conveyed to the experimental cohort.
What does this have to do with our management of COVID-19? Lobisco who focuses much of her patient treatment using essential oils is concerned about the pervasive fear we are dealing with in the pandemic. She thinks that fear is so overwhelming that patients lack the hope that can heal. The fear is not only making it difficult for our immune system to fend off the virus, but it is causing undue anxiety, depression, and insomnia. Only by changing our patient’s mindset can we prevent more illness and restore health.
Just for Fun: My Brilliant Friend by Elena Ferrante
Alright, this is not integrative or functional medicine, but I just wanted to give a shout-out to a particularly well written and delightful to read novel or rather four-part Neapolitan novel. Too many novels do not satisfy; this is not the case with Ferrante’s story of Lila and Lenu, two youngsters in post-World War II Naples who not only grow up together but remain close friends through adulthood and then into old age. For those who think of Florence, Rome, and Venice when they talk about Italy, Naples remains the poorer, more dangerous part of the country, one that many opt not to visit. The community that Lila and Lenu inhabit is full of life that tourists rarely set eyes upon. Life is tough, work is difficult and pays poorly, but people still live a rich life eating as best they can, enduring the challenges scraping by even when the camorra takes what little one makes.
The story is a gem because it looks at life from Lenu’s viewpoint. She’s the daughter of a porter, quite smart, but timid, needing to follow in Lila’s footsteps who is bold, cocky, willing to break the rules, and is even smarter. Lila says what she feels and is uninhibited with one and all. Their lives take different paths when they become old enough for middle school. Lila is needed to work with her father’s shoe repair shop; Lenu stays in school despite her mom’s resistance. The story is rich and keeps you glued in every chapter. For your next vacation, for your partner, this is well worth your while for taking your mind off of medicine. If you don’t want to invest the time in novel reading, My Brilliant Friend is a 2-season TV series available now; a third season is in the works. Both the book and the TV show are translated from Italian and the translation is excellent.
