Summary of the Bill
Currently patients have access to fill these medications with their compounding pharmacist with a prescription from their doctor. However, the FDA, under auspices of safety and at the direction and recommendation of Big Pharma, is drafting guidance and eliminating patient access to life-improving, lifesaving, and affordable customized compounded medication that cannot be prepared by local store front pharmacies like Walgreens.
Under the auspices of safety, FDA is stating that these compounded medications "do not have proof of their effectiveness" even though they have been prepared and prescribed safely for years. These changes are designed to provide Big Pharma an even bigger monopoly by increasing the cost of medication, eliminating access to precision customized medication, eliminating patient options to medications and preventing patients with preexisting conditions access to their medication. This is the medication the patient and their doctor have chosen to utilize.
The PCAC (Pharmacy Compounding Advisory Committee) is an additional layer the government has placed to help protect the FDA's liability for the elimination of these APIs (active pharmaceutical ingredients) to help the FDA look unbiased while taking away patients' medication freedoms. The FDA has leveraged the PCAC committee and USP review, stating insufficient evidence was provided for a benefit to patients even though they have been used for years and in some cases decades. The PCAC ruled that many of these active pharmaceutical ingredient formulations were ineffective and therefore 503A pharmacies are unable to fulfill their prescriptions.
Many citizen petitions have been filed by doctors to protect their patients' access to medications they have used effectively during patient care. These petitions were sent to the FDA and PCAC to stop this insanity, but were ultimately ignored. This means that your doctor, veterinarian and pharmacist recommendations don’t matter because the FDA is in control of your health and control which active pharmaceutical ingredients can be used to make medications
FDA guidance documents have been filed under the auspices of safety to block 503A compounding pharmacies and restrict important medications to patients in need with the ultimate goal of preventing patient access to compounded pharmacy medicine. Medicine that has been used for decades for both animals and humans. This bill will impact the lives of patients and protect their medical freedoms, especially in time of need.
Big Government Infringement on Your Medication
The FDA assembled a biased group of pharmacists (PCAP) -to reject the nomination of compounded medication API (active pharmaceutical ingredients), preventing access to bioidentical hormones, chemotherapy, nutrients and veterinarian medications to name a few. Under FDA interim guidance documents, the FDA is stopping the use of life saving compounded medications for patients, removing access to important compounded medications for patients with chronic and terminal illness. Big Pharma stake holders stand to gain big and patient options are eliminated to the one-size-fits-all treatment which is often not viable for patients facing chronic and terminal illness or preexisting conditions. Ultimately, tailored, precision medications are under attack and costs will sky rocket for a one-size-fits-all drug.
- CHRONICALLY ILL PATIENTS AND TERMINALLY ILL PATIENTS HAVE THE RIGHT TO DETERMINE, WITH THE ASSISTANCE AND GUIDANCE OF THEIR HEALTH CARE PROVIDERS, INDIVIDUAL COURSES OF TREATMENT THROUGH THE USE OF MEDICATIONS AND TREATMENTS OBTAINED FROM A COMPOUNDING PHARMACY.
- COMPOUNDING PHARMACIES THAT ARE LICENSED IN THIS STATE SHALL HAVE ACCESS TO ACTIVE PHARMACEUTICAL INGREDIENTS, INCLUDING ANY MEDICATIONS, DIETARY SUPPLEMENTS AND AMINO ACIDS, THAT MEET UNITED STATES PHARMACOPEIA MONOGRAPHS AND THAT MAY BE RESTRICTED FROM USE BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION IN ORDER TO PROVIDE CHRONICALLY ILL PATIENTS AND TERMINALLY ILL PATIENTS WITH THE PRESCRIBED INDIVIDUAL COURSE OF TREATMENT.
- COMPOUNDING PHARMACIES THAT OPERATE PURSUANT TO THIS SECTION SHALL COMPLY WITH THE REPORTING REQUIREMENTS PRESCRIBED IN THE RIGHT TO TRY ACT OF 2017 (P.L. 115-176; 132 STAT. 1372; 21 UNITED STATES CODE SECTION 360bbb-0a).
- FOR THE PURPOSES OF THIS SECTION:
- "CHRONICALLY ILL PATIENT" MEANS A PATIENT WHOSE PHYSICIAN HAS DIAGNOSED THE PATIENT AS HAVING A LONG-TERM HEALTH CONDITION THAT MAY NOT HAVE A CURE AND WHO MIGHT BENEFIT FROM INDIVIDUALIZED OR SPECIALIZED MEDICATION THAT IS NOT COMMERCIALLY AVAILABLE.
- "COMPOUNDING PHARMACY" MEANS A PHARMACY THAT IS CLASSIFIED AS A 503A PHARMACY BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
- "MONOGRAPHS" MEANS QUALITY STANDARDS FOR PRESCRIPTION MEDICINES AND DIETARY SUPPLEMENTS THAT ARTICULATE THE QUALITY EXPECTATIONS FOR A MEDICINE OR DIETARY SUPPLEMENT, INCLUDING ITS IDENTITY, STRENGTH, PURITY AND PERFORMANCE.
- "TERMINALLY ILL PATIENT" MEANS A PATIENT WHOSE PHYSICIAN HAS DIAGNOSED THE PATIENT WITH A DISEASE THAT, TAKING INTO ACCOUNT THE PATIENT'S MEDICAL CIRCUMSTANCES, WILL CAUSE THE PATIENT'S DEATH IN A REASONABLY FORESEEABLE TIME.
Why Compounding is Essential
Many patients have unique healthcare needs, including pets, pediatrics, oncology, chronic disease, or a desire for integrative medicine to name a few. These are different from the one-size-fits-all mass produced Big Pharma medications that cannot meet the needs of all patients. Patients require personalized medications that are prescribed by licensed medical practitioners. These medications are prepared by trained and licensed pharmacists which are regulated by state boards with FDA oversight.
Compounding of medications is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient based on each doctor's prescription. Compounding includes the combining of two or more drugs (as defined by USP monograph and Dietary monograph). Compounded drugs are not FDA-approved nor are they required to be, yet they are vitally important in a variety of medical treatments for pets and human care, especially those with terminal and chronic diseases. Often these medications have been around for decades and now FDA is restricting the use of medications and treatment options that help millions of patients.
Rich history of helping patients- In the 1930’s and 1940’s, approximately 60 percent of all medications dispensed were compounded. Then in the 1950s and 1960s, with the creation of commercial drug manufacturers, compounding was forced to decline. The Ultimate FDA goal is to limit compounding altogether.
Why the Medical Freedom Bill is Needed to Protect Against FDA Action
Having access to life supporting and/or lifesaving medication is the core principle under attack that this bill aims to protect. Understanding why the one-size-fits-all pharmaceutical drug model does not work for every patient is central to understanding why patients need access to USP and Dietary monographs prepared by compounding pharmacies as congress intended.
Having access to life supporting and/or lifesaving medication is the core principle under attack that this bill aims to protect. Understanding why the one-size-fits-all pharmaceutical drug model does not work for every patient is central to understanding why patients need access to USP and Dietary monographs prepared by compounding pharmacies as congress intended.
By removing access to these monographs, the FDA is attempting to control doctors' practice of medicine rights by removing the abilities of compounding pharmacies to prepare patient specific medications. This attempt to limit physician prescribing rights is critically problematic for patients with chronic and terminal illnesses that cannot afford to have these medications removed from their treatment protocols. The FDA is systematically eliminating these options for doctors and patients alike which will lead to poor treatment outcomes and reduced quality of life for these terminally ill patients.
Via Big Parma efforts, the FDA is attacking the doctor's ability to provide personalized and precision medicine for both human and animal patients. The systematic removal of USP and Dietary monograph agents under the auspices of safety from the currently approved agents available to compounding pharmacies will not lead to safer medications and will only lead to poor outcomes for patients. It is important to know that these agents have been available and used for many years by patients and doctors in the state of Arizona. This bill is designed to protect our existing medication freedoms which every doctor and patient should have rights to.
How The FDA is Planning the Systematic Removal of Life-Supporting Agents
During the last 3 years, the FDA has been systematically attempting to remove pet medications, bioidentical hormones, dietary monographs, natural supportive agents, specific chemotherapeutics and others beneficial drugs from compounding pharmacists through the creation of the PCAC (Pharmacy Compounding Advisory Committee). The PCAC is a biased comity of pharmacists chosen by the FDA to review and modify the lists of agents available to compounding pharmacies.
This includes the removal of important agents that are personalized by doctors prescriptions to treat pre-existing conditions which will be particularly devastating for chronic and terminal illness patients. Allowing the patient and the doctor to have access to important life supporting or lifesaving medications based on the doctor’s prescription is critical to maintain medication freedoms for all.
Both animal and human patients rely on these customized medications to provide specific drug forms or dosing modifications, tailored drug combinations, and the removal of allergens; Medications doctors and veterinarians have relied on for years to help their patients will be eliminated unless this bill is enacted. We seek to preserve what we have always had access to and what Big Pharma is attempting to steal from patients.
FDAs Opposition to Compounding Pharmacies
According to FDA, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for FDA-approved (Food and Drug Administration) drugs; as such, compounded drugs may pose additional risks to patients. FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations (GMP), which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMP, and testing to assess product quality is inconsistent even though compounders have oversight by the state board of pharmacy and FDA alike. Unlike FDA-approved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy like commercial drugs; that is to say, they have not gone through clinical trials. In addition, compounded preparations do not have standard product labeling or prescribing information with instructions for safe use. Compounding pharmacies are not required to report adverse events directly to the FDA, which is mandatory for manufacturers of FDA-regulated medications. Instead, compounders report to the state board of pharmacy which in turn reports to the FDA.
The problem here is that precision medication made by compounding for each individual prescription can not go through drug approval for efficacy, or standard cGMP production used for Big Pharma drugs, or undergo full scale clinical trials. Compounders take already existing, approved drugs with USP monographs or Dietary monographs and combine these already approved and well-defined API (active pharmaceutical ingredients) to combine and prepare each doctor's individual prescription for each patient. Each medication prepared undergoes the required sterility and stability testing set by state board for 503A pharmacy and all records and safety data is kept for inspection by both state board and the FDA. Therefore compounders operate with safety criteria that is different from Big Pharma and impossible to accomplish for unique and various combinations of dose form and strengths. These combinations of medications greatly help human and animal patients, and it is impossible to compare each combination to a commercially approved one-size-fits-all drug sold at Walgreens. Precision prepared and compounded combinations are particularly important for patients with chronic and terminal illness that need access to targeted unique prescriptions that only a compounder can prepare, as they have for almost 100 years, to extend or save lives.
How the FDA Aims to Accomplish Their Mission
The FDA and PCAC are actively ignoring evidence based around the use of certain USP and Dietary monograph active pharmaceutical agents which may have important clinical functional value for patient care including supporting biochemistry and overall physiology. Functional value that has been noted by practicing doctors and veterinaries to help their patients.
Instead, the PCAC only favors the use of synthetic drugs that are solely approved to treat a singular disease, supporting the one-size-fits-all Big Pharma mantra to continue their monopoly and prevent patient options.
Additionally, the FDA has refused to consider monographs with all vital agents developed by the United States Pharmacopoeia (USP). Their refusal runs counter to the original Congress mandate that all “applicable” monographs can provide a basis for compounding.
With the recommendation and endorsement from Big Pharma bias, the FDA and PCAC are attacking patient medication freedoms and systemically removing compounding agents to increase their personal monopoly of the one-size-fits all model at the cost of patient care putting a stronghold over citizens and ultimately impacting their current medical care.
FDA Uses the Bad Apples to Shut Down an Industry
Some bad compounding pharmacies have engaged in activities that extend beyond the boundaries of traditional pharmacy compounding, such as massive large-scale production of compounded medications without individual patient prescriptions, compounding drugs that have not been approved for use in the US, and creating copies of FDA-approved drugs (all of which are against the law). According to the FDA, compounded drugs lack GMP, and this increases the potential for preparation errors. However, it is important and vital to understand that compounders in line with state regulations use safety standards though GMP is not possible with every single variation and combinations for individually prepared medications.
Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs (It is important to emphasize there are bad actors in every industry, however, it is impossible to compare a commercial one-size-fits-all, mass-produced GMP drug to the process used to customize a compounded medication for each patient. Each process has their own safety requirements and each method is needed in medication preparation for patient care).
Compounded sterile preparations pose the additional risk of microbial contamination to patients when not tested or prepared correctly. In the last 11 years, FDA notes three separate meningitis outbreaks that have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The most recent 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances (Essentially, the FDA used these outbreaks take control of compounding pharmacies, something they been trying to do for decades).
The FDA has aggressively cooperated with Big Pharma and the media to warn patients and healthcare practitioners to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk. However FDA has not warned patients and doctors of problems with Big Pharma drugs and API (active pharmaceutical ingredients) problems with medication made in FDA-approved facilities in foreign countries. The point being the FDA is conveniently selective in its protection of the public. Meanwhile, good compounders in line with state pharmacy boards have been preparing important, high-quality medications for their patients for many years, but a few bad apples exist in every industry.
Why the FDA Will Not Share This With the Public
Our point here is that FDA picks and chooses the industry they want to shut down because it protects the Big Pharma monopoly. Good compounding pharmacies know the API and test their products for quality and care for their patients.
Safety and quality of batch testing in good compounding practices solves these problems in foreign FDA registered API manufactures in China. Patients trust that their compounding products are free of carcinogens from china-manufactured medications the FDA is allowing to enter freely into our national medication market.
Hormones Under Attack
Patients deserve options when it comes to what they put into their bodies. Many patients don't want one-size-fits-all synthetic hormones. They instead prefer customized options for chronic hormonal imbalances. It is estimated 7 million patients are using bioidentical hormone therapies that the FDA wants to remove from compounding.
Bioidentical Hormones Being Removed
The cost of bioidentical hormones will sky rocket by over 100% and many options and dosing forms will be removed because of the FDA. Big Pharma hopes to monopolize by forcing their one-size-fits-all option on the country to the tune of 7 million patients paying over 100 dollars a month or more. Big Pharma is estimated to make 700 million to a 1 billion in sales a month. By shutting down compounding pharmacies' ability to customize bioidentical hormones, Big Pharma will force the use of one-size-fits-all hormone medications for patients while monopolizing the market.
Background On Bioidentical Hormones
Bioidentical hormones are different from those used in traditional hormone replacement therapy (HRT) in that they’re identical chemically to those our bodies produce naturally and are often made from plant estrogens. The hormones used in traditional HRT are made from the urine of pregnant horses and other synthetic hormones. Many patients don't like this option
Many doctors and patients prefer bioidentical hormones because they feel the products are safer because they are “natural” and identical in makeup to the hormones the body produces naturally. Compounding pharmacies provide many forms of hormone delivery methods including orals, creams, lozenges, and injections at various doses personalized for each patient at an estimated half of the cost of synthetic hormones. Big Pharma via FDA is wanting to switch 7 million patients from using bioidentical hormones by eliminating them from 503A compounding pharmacies. Hormone imbalances are often chronic conditions that involve long term custom treatments. Patients deserve to protect their options.
Article - Gender Bias in the Treatment of Menopausal Women
Oncology Under Attack
Cancer patients deserve options, and lifesaving compounded medications should not be restricted. 1 in 2 women and 1 in 3 men will develop cancer in their lifetime and they need precision medicine options. The FDA is attempting to greatly restrict these options.
Oncology Options Under Attack
Chemotherapy treatments have an average pricing range from 7,000 to 40,000 dollars per treatment; with the advent of smart drugs, these costs can skyrocket, pushing some patients over a million dollars in insurance billing for cancer treatment. The FDA, via their guidance documents, is preventing 503A pharmacies from compounding various chemotherapy agents and integrative supportive agents. With the important advent of precision medicine, many patients seek integrative care for cancer treatment. In fact, an estimated 60%-80% of all patients with cancer are using some form of integrative medicine to help them through the side-effects. The FDA, via the lobbying efforts of Big Pharma, has targeted these agents to secure their monopoly in this multi-billion dollar oncological industrial complex.
The mistake here is that many patients need integrative support alongside standard chemotherapy treatment or modification to chemotherapy to improve quality of life and progression-free survival. Compounded chemotherapy drugs are combined to provide a customized compounded treatment agent that allows the patient to receive custom doses and combinations of medication that only 503A pharmacies can provide. These medications greatly increase patients options to care and improve outcomes and quality of life. Based on the practice of medicine and patients working with their doctors, Americans deserve not to have their medical liberties removed.
Patients want to receive dietary supplements prescribed by their doctors to boost their nutrition and immune system, especially with chronic and terminal illnesses. IV Myers Cocktails have been around for decades and have had positive impacts for patients needing advanced nutrition. The FDA has never had a favorable view of dietary monograph agents, and they want to remove dietary monographs from compounding.
FDA to Remove Dietary Monograph Agents
76% of U.S. adults—more than 170 million patients—take dietary supplements, according to the CRN 2017 Survey on Dietary Supplements conducted by Ipsos Public Affairs on behalf of the association. The FDA, via their interim guidance list created by their "hand selected pharmacist and nominations by Big Pharma," is shutting down the option to have these dietary products made by a compounding pharmacy. It is critical for a compounding pharmacy to be able to compound these agents from physician prescriptions as it has safely been done for decades because patients require tailored dosing, strengths, and formulas.
Cancer patients need supportive IV nutrient treatments and chronic disease patients need additional IV support as well. IV Myers nutrients have become very helpful for wellness and support of chronic diseases by helping those with fatigue. Often patients can not take the therapeutic amounts of the dietary supplements products via oral absorption, and when the treatment is given intravenously, it can have enhance the quality of life for many patients. Because the FDA cannot stop naturopathic, functional medicine, or really all integrative doctors (representing as many as tens of thousands of doctors) from practicing medicine, the FDA attacks and stops the dietary monograph products from being made by compounders.
To learn more, view the citizen petition submitted by the American Association of Naturopathic Physicians, pleading to save key medications and to help save and heal patients. The FDA and Big Pharma have had a long history of prejudice in attacking complementary, natural, integrative and alternative medicine. Patients and doctors deserve the right to care for their patients as they deem fit, from B12 injections to IV vitamin C and other nutrients to support their patients.
Important agents like curcumin, quercetin, alpha-lipoic acid, and glutathione are commonly used by patients and are at the top of their removal list via their guidance documents. Even though integrative doctors submitted thousands of documents and testified to the FDA, they still have placed them on the chopping block. These agents have been especially helpful during the COVID-19 pandemic, these dietary agents have been life saving to many patients by bolstering their immune systems.
What is a Monograph and Why is it Important?
503A compounding pharmacies for decades have been able to provide medications both from USP monograph and dietary monograph. A drug monograph is a predetermined checklist covering active ingredients, doses, formulations and product labeling that the agency considers generally safe and effective for self use. A monograph is a written standard that establishes public specifications for an article (e.g., drug substance, drug product, excipient, food ingredient, dietary ingredient, or dietary supplement). A monograph published in any USP compendium provides: the name of the article; its definition; package, storage, and labeling requirements; and a collection of tests with their acceptance criteria needed to ensure identity, strength, performance, composition, purity and absence of contaminants. For decades 503A Pharmacies have been able to compound both USP drug and dietary monographs. FDA has systematically aimed to eliminate the dietary monographs altogether. Under the recommendations of Big Pharma, the FDA has created a guidance list that eliminates dietary supplement products from compounding for pharmacies. The goal is the elimination of the practice of naturopathic medicine, functional medicine, and any integrative healthcare. Under the auspices of safety, the FDA and their assembled "board of pharmacists" at the recommendation and nomination from Big Pharma, is systematically aiming to take away your options in healthcare.
Here is the AANP Citizen Petition to FDA
This document was filed to the FDA, pleading them to stop this attack on integrative medicine that help patients. To this date, the FDA has given no response, and without your help they are likely to continue their systematic attack and removal of integrative medicine. They will continued to shut down patient options, leading to more money for Big Pharma as sick patients are forced into a one-size-fits-all system of medicine.
While the FDA is concerned that dietary supplements may be harmful or can replace "real drugs," the 503A compounding pharmacy only prepares dietary monograph products (supplements) prescribed by a lessened doctor/healthcare professional with prescribing rights. Therefore, the safety and efficacy of these prescriptions are determined by doctors and discussed with their patients; together, decisions are made. Physicians are far better trained to decide with their patients what the best course of treatment is rather than FDA attempting to control their options by limiting prescriptions. These dietary monographs have been compounded safely for decades. In fact, concerning the medication that caused FDA to pass legislation to further control compounding in 2012, "The New England Compounding," gross problems were related to epidural steroidal preparations and not the dietary monograph agents.
Citizens Petition from (AANP) American Association of Naturopathic Physicians
Veterinary medications play a significant role in the management of disease, yet one study showed more than one-third of clients find administering medications to their pet to be challenging. Compounding makes this easier and is greatly helping pets with chronic and terminal illnesses.
Veterinarian Medicine Pet Freedoms Abolished
68% of American households are estimated to have at least one pet, with 63% of owners considering their pets to be members of the family. With recent advances in medicine, pets are living longer, just like their human counterparts. A longer life expectancy means more animals develop chronic diseases, which can be costly to manage under the Big Parma model. Additionally, many medications need to be customized for our pets, and this customization can only be effectively accomplished by 503A compounding, as it has for decades.
Need for 503A Pharmacies for Pets
Veterinary medications play a significant role in the management of disease, yet one study showed more than one-third of clients find administering medications to their pet to be challenging. Pets injuring their owners at the time of administration, avoiding medications due to lack of palatability, and refusing to swallow tablets or capsules are all barriers to effective medication adherence.
503A compounding pharmacists are uniquely positioned to help patients find solutions to medication problems and to collaborate with local veterinarians to provide the best care for their mutual patients at the best cost. Prescription filling trends show that clients increasingly seek to fill their pet’s medications at community pharmacies. Pharmacies that specialize in compounding regularly serve pets and their owners, but most retail pharmacies do not currently offer this service. Therefore, community pharmacies offering veterinary compounding services usually offer low cost medications, solutions to medication administration challenges, and convenient hours and locations to help pets with the unique dose forms and combinations that are needed.
503A Under Attack
The FDA will eliminate the ability to compound these lifesaving medications for pets and ultimately increase costs by 80-100% per prescription by attacking 503A compounding pharmacy rights.
The FDA removal and/or limitation of pet medication compounding will result in the inability for 503A compounding pharmacies to create and fill prescriptions from veterinarians (this will cause a lack of access to many life saving medications for pets and force all family members of pets to pay 80-100% more for the same prescription filled by Big Pharma). Sixty-seven percent of U.S. households, or about 85 million families, own a pet, according to the 2019-2020 National Pet Owners Survey conducted by the American Pet Products Association (APPA). They would all be affected by FDA's guidance on 503A compounding medicine. (This would nationally increase pet drug cost by billions of dollars and more importantly eliminate many life saving custom pharmacy medications for pets)
Who is causing the problem? The FDA, and why? Because of Big Pharma lobbying to shut down compounding pharmacies to control full market share. The FDA has adopted all Big Pharma recommendations to continue their monopoly and eliminate our options as patients.
History of Compounding
In the 1930’s and 1940’s, approximately 60 percent of all medication dispensed was compounded. Then in the 1950's and 1960's, with the creation of commercial drug manufacturers, compounding was forced to decline. It was during this time that a pharmacist, known as a compounder or apothecary at the time, became known as a dispenser of manufactured drugs. In the 1980’s and 1990’s, patients and doctors began realizing the need for specific doses and customized medications. Today, almost 43,000 compounded dosage forms are dispensed each day.
Why 503A Compounding is Essential
Many patients have unique healthcare needs (pets, pediatrics, oncology, chronic disease, and integrative medicine to name a few) that are different from the one-size-fits-all, mass manufactured Big Pharma medications. Patients require personalized prescribed medication by licensed practitioners, prepared by trained, licensed pharmacists that are regulated by state boards and have FDA oversight.
Working with a physician, a compounding pharmacist can prepare customized medications Working with a physician, a compounding pharmacist can prepare customized medications (in a safe manner) to meet the individual needs of children, adults and pets.
Why 503A is Critically Needed in Health Care
- When required medications are unavailable from pharmaceutical companies (very common).
- When patients have allergic reactions to preservatives, dyes or binders in available off-the-shelf medications that need safer combinations.
- When the treatment requires tailored dosing, strengths and forms (very common) in chronic and terminal diseases.
- When pharmacist need to combine medications that are not found in commercially available drugs for compliance and/or personalized medicine.
- When patients cannot ingest the medication in its commercially available form.
- When medications need flavors to make them more palatable for patients to receive medication.
- When patients need different dose forms like creams, lozenges, injections or orals.
- When critical combinations support, improve, and extend life that are not found among commercially available drugs sold.
What is 503A Compounding?
The FDA has designated 503A compounding pharmacies as those that compound according to prescriptions specific to particular patients and are required by state boards of pharmacy to comply with USP and other guidelines.
These facilities are limited to dispensing only for home use and are not allowed to compound large batches, an ability that leads to greater personalized medicine and to the lowering of drug costs.
503A facilities are more closely related to what might be considered "traditional compounding pharmacies." They provide compounded medications to fill individual patient-specific prescriptions.
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient based on each doctor's prescription. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved but are essential in a variety of medical treatment options for pets and humans.
How is 503A Pharmacy Regulated
All pharmacies and pharmacists, including compounding pharmacists are licensed and strictly regulated by individual State Boards of Pharmacy. Additionally, the FDA (Food & Drug Administration) has authority over key aspects of compounding. Standards are set by the United States Pharmacopeial Convention (USP) and are mandated and integrated into 503A compounding practices.
Why 503A Pharmacies are Under Attack
503A compounded medications are often necessary to effectively treat patients, but there are frequently news headlines reminding the public that these compounded medications can pose a risk with regard to quality. However, selecting a high-quality compounding pharmacy can decrease the risk of receiving a low-quality product. One way to evaluate quality is whether the compound is coming from a 503A or 503B pharmacy.
The biggest difference between these two types of pharmacies is that 503A pharmacies compound medications in accordance with United States Pharmacopeia (USP) Standards and are regulated by the states, while 503B pharmacies compound medication in accordance with Good Manufacturing Practices (cGMP) and are regulated by the Food and Drug Administration.
No matter where you get your product, from a 503B compounding facility or a 503A, all pharmacies should provide the following:
- The drug has been proven to contain the correct amount of active drug (suitability).
- The drug is stable until its “beyond use” date (expiration date).
- The drug is sterile (if it’s a sterile product).
While preparing compounds in line with cGMP manufacturing standards produces a higher quality product due to all the additional testing required, these 503b facilities are limited as they only focus on making essential medications defined by their limited guidance list and not precision medication that has been made for decades by 503A community pharmacies.
If you need a product designed to meet the needs of a specific patient, such as a particular flavor, combination, custom dose, unique delivery method or a unique suspension, then a 503A pharmacy is essential. 503A pharmacies have been around for decades and are state regulated with FDA oversight.
Despite their differences, both types of compounding pharmacies have a place in healthcare. 503A pharmacies are the traditional compounding pharmacies that make patient-specific medications in small quantities and have done so for decades (highly customized at a reduced cost). However, oftentimes the medical profession has a need for an essential drug product that is made in large batches following cGMP. 503B pharmacies are essential for manufacturing compounded products that do not allow for customization needed for patient care. 503A pharmacies are critical in the treatment of chronic and terminal illness for both humans and pets.
New England Compounding Story
The FDA used New England Compounding's huge errors to create sweeping legislation to impact all 503A pharmacies. Safety standards are something all good compounders practice, however, under auspices of safety, the FDA is removing critical healthcare options for patients. Big government never lets a good opportunity go to waste. Most pharmacies are high quality operators that have been helping patients for decades.
Defining the FDA's role regarding pharmacies is at the heart of a regulatory battle to draw the line between manufacturing and compounding, each a unique system of filling prescriptions. Manufacturing means making an FDA-approved product (usually a single drug) in mass quantities for distribution to a large market. Compounding, whether it involves blending bulk raw ingredients or creating variations of existing manufactured drugs, is geared for specific patient prescriptions and the delivery of precision medicine for patients that need these variations. Critically important for treating pre-existing conditions, chronically ill, and terminal patients both humans and pets.
Clearly and unequivocally, FDA used New England Compounding to gain access to Congress to regulate compounding pharmacies. Big Pharma has the ear of FDA, and they're complaining about losing business to compounding pharmacies who make specialized combinations for patients in need of medication that is not commercially available. 503A compounders don't make cloned drugs; they make products for individual patients based on prescriptions from doctors and have been safely doing so for decades.
New England Compounding Story Background
Public View of 503A Compounding, Increasing Federal Regulations
The FDA is using the abuses of a few 503A bad operators line New England Compounding to shut down access to important medications for patients. Federal regulations are now removing agents that were never dangerous to begin with and penalizing all doctors, patients who need these medications to sustain their lives and treat chronic conditions.
This bad stigma is discussed below on the Tonight with John Oliver talk show. This is not true of most 503A compounding pharmacies but is being used to discredit and prevent important access to medications that can only be made in a 503A compounder for chronically and terminally ill patients. Bad Media and Big Pharma are at work discrediting 503A compounding.
FDA Failing Oversight of Big Pharma and 503A US Pharmacies are Far Safer and Personalized.
"URGENT PRODUCT RECALL," blared the words at the top of the letter from Big Pharma. FDA is attacking 503A compounders because Big Pharma is complaining about losing business to compounding pharmacies who make specialized combinations. However, FDA turns a blind eye to huge Big Pharma impurities and dangers. Double standards in the deep state at the FDA, anything to protect the interest of Big Pharma in the name of safety. If we lose 503A compounding, patients will lose options that are critical to patient health.
Pharmacy Regulatory News
New Updates on Compounding Battle
National Academies of Science, Engineering, and Medicine (NASEM) study from APC Town Hall
Summary of recent updates from APC (Alliance for Pharmacy Compounding) Town Hall regarding the NASEM study and compounded hormone replacement therapy:
- NASEM has changed the term "Bio-Identical Hormone Replacement Therapy" (BHRT) to "compounded hormone replacement therapy" (cHRT) in an effort to confuse the public and implicate compounding pharmacies in lieu of the NECC disaster.
- Of the more than 150 studies submitted to NASEM; they based their recommendations on ONLY 13, 8 of which discussed the use of DHEA, a component not used in most compounded Rx formulas.
- The recommendation to place all hormones on the "Difficult to Compound list" was made by an ex-FDA official who is now part of the NASEM committee.
- The study re-defined "clinical utility" to specifically exclude patient preference.
- It was made clear that the FDA would repeatedly outsource "studies" to a group stacked with former FDA and Pharma officials to use against us in the future.
- No time frame has been signaled by the FDA and it is unclear when they will go "all-in" and tackle this issue.
What is APC (Alliance for Pharmacy Compounding) doing to combat this study:
- 1700 patient testimonials have already been submitted through a Patient Portal developed by APC (www.a4pc.org/cbhtandme). Please check out this portal.
- As of now, the NASEM study is the only thing policymakers are hearing. APC is proposing to fund a third-party analysis of studies, clinical data, and patient experience to refute the NASEM study, estimated to cost approx $100,000.
- A "House Letter" is circulating to send to FDA, currently with 17 signatures from a diverse group of Congressmen and Women, and it's likely more signatures will be obtained after the election. Our Congressman, David Schweikert, has NOT signed on.
- A comparable "Senate Letter" to FDA is also being considered, possibly from a coalition of female Senators; also, I suggested that Senator Rand Paul's office seemed ready to generate a letter after meeting with them last week.
- APC is also considering a consumer media campaign that will feature patient testimonials about the benefits of compounded hormone therapy, and inform the public that the FDA is looking to take them away.
- APC is educating Congress members about what cHRT is, how it works, how we make it, and its benefits to patients. BEFORE raising the volume on FDA's over-reach.
Recommendations for compounders:
- Educate providers about the NASEM study, their recommendations, and how this will affect their patients.
- Inform providers about the patient portal and recommend cHRT patients visit and submit comments on their experiences taking compounded hormones.
- Post a link to the Patient portal on compounder websites and social media.
The MOU has been published in the Federal Register at https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-significant-milestone-compounding-program-protect-public-health-through
APC's comment - "looks like we're heading for lawsuits" https://a4pcnews.com/2020-10/fda-posts-final-mou-disappointing-but-not-surprising/
We should probably contact the state board to determine when it will be on the agenda and to hear what they have to say. Do we want the state to sign a flawed document or not?
Law suits have started against the FDA on the issue.
Compounders Lawsuits Against FDA Based MOU Restrictions 2004
Washington—As the Food and Drug Administration (FDA) works to rewrite guidelines for compounding pharmacies, two lawsuits have emerged accusing the government agency of overstepping its regulatory bounds and unfairly targeting the industry.
The lawsuits, one filed on behalf of 10 compounding pharmacies and the other by Kentucky-based Bet Pharm LLC, challenge FDA's jurisdiction over compounders and call a recent rash of federal inspections unwarranted, unauthorized, and illegal.
Defining the FDA's role regarding pharmacies is at the heart of a regulatory battle to draw the line between manufacturing and compounding, each a unique system of drug distribution. Manufacturing means making an FDA-approved product in mass quantities for distribution to a large market. Compounding, whether it involves blending bulk raw ingredients or creating variations of existing manufactured drugs, is geared for specific patient prescriptions.
State pharmacy boards traditionally regulate compounding pharmacies, but to eliminate suspected copycat or banned products, FDA officials have executed a series of search warrants to inspect a handful of players in the veterinary market, including BET Pharm, where agents seized products from the equine fertility drug maker in August, court documents show. FDA officials describe BET's production as "large scale."
"There are a group of pharmacists who are desperately trying to protect their current practice, which as we have said all along constitutes illegal manufacturing," says Dr. Kent McClure, general counsel for the Animal Health Institute (AHI), which represents pharmaceutical manufacturers. "The only reason to run to court right now is to protect the prerogative of illegal manufacturing and to tie the FDA's ability to enforce."
Waiting for rebuttal.
In the present time, the FDA had not filed responses to the lawsuits and refused to comment on pending litigation. Awaiting the agency's reaction is Howard Hoffman, the Chicago attorney responsible for filing both cases.
"Clearly and unequivocally, FDA does not have a leg to stand on because Congress has not given them authority to regulate compounding pharmacies," Hoffman says. "I suspect the problem is big pharma has the ear of FDA, and they're complaining about losing business to compounding pharmacies. We contend that compounders don't make cloned drugs; they make products for individual patients based on prescriptions.
"I'm not at war with the FDA; I find them to be a worthwhile agency with an important mission. But they have to understand that there are limits to their authority. Veterinarians and physicians would be lost without compounding pharmacy to prepare what their patients need when manufacturers don't."
In the middle.
Watching the conflict between FDA and compounding pharmacies unfold are veterinarians who await the agency's revision of its Compliance Policy Guide (CPG), an internal reference for FDA agents that currently bans compounding from bulk ingredients for non-food animals.
Although the CPG is not law, critics claim the FDA threatens to enforce it as such. Veterinarians, concerned they will lose access to non-veterinary drug equivalents, seek guidance from the American Veterinary Medical Association, which has spurred the FDA to revise the CPG for clarification.
That revision is expected before next year. In the meantime, AVMA is creating a pocket guide on the dos and don'ts of compounding. At present, brochures were at the approval stage.
"I'm advising all our members to keep on waiting for the CPG," says Dr. Bruce Little, AVMA executive vice president. "I think until interpretations are made, it would not be a wise move for veterinarians to use compounded drugs."
First Amendment issues.
While CPG uncertainties muddle the rules directing compounding, the lawsuits don't help. The multi-pharmacy lawsuit names U.S. Attorney General John Ashcroft, Health and Human Services Secretary Tommy Thompson, and acting FDA Commissioner Lester Crawford, DVM, as defendants. It contends that along with unlawful enforcement of the "purely internal" CPG, FDA has violated the plaintiffs' First Amendment rights to advertise by forcing tradeshows to require that compounding pharmacies sign a statement of compliance with the CPG.
While the tradeshow aspect adds a new twist, the American Association of Equine Practitioners' event and the Western Veterinary Conference (WVC) are the only meetings known to require them.
WVC Executive Director Dr. Steve Crane says the decision to require an affidavit was voluntary, not FDA derived.
"Caught in the middle like we are, we want to make sure everyone is aware of the laws even if they aren't that clear," says Crane, who reports roughly a dozen compounding pharmacies in line to exhibit at WVC next year. "Compounding pharmacies do an extraordinarily valuable service for all of us when they fill custom prescriptions, but in the case of illegal manufacturers, I don't want that liability on the tradeshow floor."
Rocking the boat.
Risks especially emanate from the lawsuits themselves. A major association representing compounding pharmacies says, "While the International Academy of Compounding Pharmacists (IACP) did not return repeated phones calls from DVM News magazine seeking comment, in an e-mailed letter the group warns that litigation might damage the relationship IACP has worked hard to develop with FDA."
The letter state, "while IACP agrees that pharmacy practice should be regulated by state boards of pharmacy and not FDA, we have several concerns with this litigation."
"First, we are concerned with the timing of the lawsuit. IACP members have invested substantial time, energy, and finances to generate political pressure to motivate the FDA to withdraw the CPG. We believe that the pressure resulting from our actions has caused FDA to rethink this flawed CPG, and in turn, they have now publicly stated that a new CPG is being drafted and will be released for public comment."
"Second, we are mindful that there is risk in taking legal action if pharmacy should lose at the appellate level."
"As for the BET Pharmacy seizure case, IACP is reviewing the facts to see if action is warranted, the letter adds."
"Action against FDA is long overdue," compounders say. Carol Peterson, a pharmacist with plaintiff Women's International Pharmacy Inc. and parent of Pet Health Pharmacy Inc., understands the FDA's position but says the CPG is "opinion only, not law." To gain access to pharmacies, FDA operates on intimidation, Peterson says.
"The FDA has been very aggressive when going into pharmacies," she says. They come in with U.S. Marshals, they're heavy-handed; they threaten to put people in prison, and they disrupt your business. You have to get a lawyer, and that's very expensive. All the while, it's questionable whether FDA should even be there.
Dr. Peterson continues, "you would think that AVMA would say, hey, wait a minute; this crackdown on pharmacy doesn't make sense. Veterinarians certainly have the right to compound themselves as well as use compound pharmacies. We have to fight."
At present, court dates for both lawsuits had not been set. While the BET Pharmacy suit is filed in U.S. District Court in Kentucky, the multi-plaintiff lawsuit is filed in Texas, far away from the New Jersey district court where a similar case by Wedgwood Pharmacy was fought and lost last year, backing FDA inspections of compounding pharmacies in that area.
AHI officials accuse the pharmaceutical plaintiffs of "forum shopping" to obtain a more favorable result. Steve Holtz, head of Premier Pharmacy in Texas, agrees.
"A court case is like football. You've got to have a game plan," says Holtz, MD. "Sure, we're going to file in a district where we think we might have the best chance. The best way to stop people from tyrannical action is to step up and fight them. Regulatory agencies will not work with you. They're more likely to run over you," Elaborated Dr. Holtz.
Pharmacies Sue FDA Over Compounded Drug Agreements in October of 2020\
(October 28, 2020, 3:03 PM EDT) -- A group of pharmacies has accused the U.S. Food and Drug Administration of exceeding its authority by developing new agreements with states that upend long-standing regulations on compounding pharmacies. A move the group says will limit interstate commerce and add burdensome reporting requirements. The FDA's recent memorandum of understanding, or MOU, that created new regulations to fully implement a decades-old rule governing pharmacy compounding under the Federal Food, Drug, and Cosmetic Act is deeply flawed and improperly developed, Wellness Pharmacy Inc. and other pharmacies said in their suit filed in D.C. federal court Tuesday
"The final standard MOU is defective both procedurally and substantively," the pharmacies wrote in their lawsuit.
In 1997, Congress created the rule that left pharmacy compounding regulation to the states, but also directed the FDA to enter into MOU agreements with states about the scope of the interstate distribution and dispensing of compounded drugs. The agency didn't follow Congress' directive until 2016 when it proposed the regulation to spell out when compounded products are exempt from federal requirements. The final MOU was issued in October.
But the final standard MOU altered a key aspect of the rule, the pharmacies said in the suit. By changing the definition of interstate distribution of compounded drugs in the MOU to include interstate dispensing, the agency disregarded the regulation's clear separation between dispensing and distribution, the pharmacies said.
By changing that definition, the agency will inevitably alter the pharmacy compounding industry's traditional practices through new reporting requirements and limits on distribution, they added.
The new MOU "exceeds FDA's statutory authority by defining 'distribution of compounded human drug products interstate' and 'inordinate amounts' to include interstate dispensing of compounded human drug products," they added.
States also have the option of entering into the agreements, which could open up another set of issues for compounding pharmacies across the country, according to the complaint.
For example, if a compounding pharmacy is doing business in a state that enters into an MOU with the FDA, it will suffer significant financial harm from the increased regulatory burdens and requirements to share information about its interstate commerce, the pharmacies said.
"The final standard MOU does not specify what FDA intends to do with such information obtained from states, such as whether FDA will conduct increased inspections or take enforcement action against pharmacies so identified," the complaint said. But pharmacies operating in states that don't enter into the agreements run the risk of being; "severely restricted in their ability to dispense compounded medications outside of their respective home states to patients who rely on these medications," according to the lawsuit.
The suit seeks to topple the entire final standard MOU, saying that the agency went outside of its authority in designing it and used improper procedures to develop it. Counsel and representatives for the parties did not immediately respond to requests for comment.
The pharmacies are represented by Rachael G. Pontikes, Emily L. Hussey, Kelly J. Kearney, and James F. Segroves of Reed Smith LLP. Counsel information for the FDA was not immediately available. The case is Wellness Pharmacy Inc. et al. v. Azar et al., case number 1:20-cv-03082, in the U.S. District Court for the District of Columbia.
Read more at: https://www.law360.com/articles/1323230/pharmacies-sue-fda-over-compounded-drug-agreements?copied=1