Who Is At Risk For Colorectal Cancer?

colorectal-canceer-awarenessColorectal cancer, or cancer of the large intestine (colon) and rectum, is the second-leading cause of cancer deaths in the United States. The rising prevalence of colorectal cancer leads to a few important questions. Who is most at risk for colorectal cancer? How do you know if you are at risk? Can you do anything to prevent colorectal cancer?

What Is a Risk Factor?

First, it is important to discuss what a risk factor is. A risk factor is any one thing that affects or increases your chances of contracting a disease, illness, or condition. There are numerous risk factors for most conditions, and having any one of them does not necessarily mean you will contract that disease. However, it does increase your risk for contracting the disease; in fact, having numerous risk factors further increases the likelihood you may contract the disease.

Fortunately, some risk factors are things you can address and change to decrease your risk. Others you cannot change, such as genetic factors. Finding out you have risk factors for a condition certainly does not mean you will contract that condition – and some people that contract a condition have no risk factors at all – but knowing your risk factors can help you address those that you can change.

What Colorectal Cancer Risk Factors Can You Change?

As mentioned, you can address certain risk factors to decrease your risk of contracting colorectal cancer. Pay attention to whether you have these risk factors:

  • Being overweight or obese. If you are overweight or obese, you are at a higher risk of developing colorectal cancer. In particular, there is a connection between a larger amount of belly fat, the corresponding larger waistline, and colorectal cancer. This connection is stronger in men than it is in women.
  • Being physically inactive. An increased risk of colorectal cancer is also linked to low levels of physical activity. Although inactivity often goes hand in hand with being overweight, some relatively thin people are inactive. Aim for at least 30 minutes of moderate physical activity per day.
  • Eating a poor diet. A diet high in certain types of foods can increase your risk of colorectal cancer. In particular, consumption of a great deal of red meats and processed meats – beef, pork, lamb, sausages, bacon, and deli meats – is a risk factor for colorectal cancer. Avoid this risk factor by eating lean proteins instead, such as chicken, fish, and turkey.
  • Carcinogenic food preparation. Cooking meats at high temperatures, such as frying, broiling or grilling, may increase your risk for colorectal cancer. Grilling or charring meats produces carcinogenic chemicals that also may increase your risk. Reduce the frequency at which you use these methods, and avoid charring your meats.
  • Consuming alcohol. Doctors have connected alcohol consumption, especially moderate to heavy alcohol consumption, to increased risk of colorectal cancer, in addition to many other health risks, especially in men. Both men and women should avoid alcohol use, or limit use to no more than two drinks per day for men, and one per day for women.
  • Smoking. It is a well-known fact that smoking is a risk factor for lung, throat and mouth cancers. However, it’s also a risk factor for many other cancers, including colorectal cancer. Quitting smoking is one of the best ways to eliminate a colorectal cancer risk factor.

What Are Colorectal Cancer Risk Factors You Cannot Change?

Unfortunately, not all risk factors are things you can address and change on your own. However, awareness of these risk factors is important:

Increased Age

Both men and women experience gradually increasing colorectal cancer risks as they age. People older than 50 are at the highest risk, though younger adults are not immune. After 50, colorectal cancer screenings are much more common and insurance usually covers them.

Race and Ethnicity

Scientists aren’t sure why, but it appears certain groups are more susceptible to cancer. African -Americans have a higher rate of colorectal cancer than any other race, as well as the highest mortality rate resulting from colorectal cancer. Ethnic Ashkenazi Jews have the highest rate of colorectal cancer in the world.

Personal History of Polyps or Colorectal Cancer

If you currently have or have a history of colorectal polyps, you have an increased risk of developing colorectal cancer. This is also true if you have previously had colorectal cancer itself, even if you had the cancer removed or are in remission – your risk of developing colorectal cancer in another part of the colon or rectum remains higher.

Family History of Polyps or Colorectal Cancer

If you have a family member – particularly, a close family member such as a parent or sibling – with a history of either polyps or colorectal cancer, you are at a higher risk of developing colorectal cancer yourself. Risk is especially high if that family member developed cancer before the age of 45.

Certain Genetic Predispositions

Certain genetic factors, mostly for polyp development, can increase your risk of colorectal cancer. These include Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, and MYH-associated polyposis. Identifying these syndromes is important to begin early cancer screenings.

Having Type II Diabetes or Inflammatory Bowel Disease

Although other factors, such as being overweight or physically inactive, also lead to diabetes and present risk factors, diabetic patients are at an increased risk of developing colorectal cancers and don’t respond as well to treatments. In addition, IBD such as Crohn’s or ulcerative colitis can increase your risk.

If you have one or more of these risk factors, consider it a reason to begin paying attention to your colorectal health. Remain vigilant in protecting your overall health and screening for colorectal cancer, and do what you can to eliminate the risk factors you can change.

Healthy Living Helps Decrease Risk Factors of Cancer

An ounce of prevention is worth a pound of cure. In addition to following the above-mentioned guidelines on how to help minimize your risk for colorectal and other cancers, consider opting for customized health treatment programs that cater to your specific needs. This includes your prescription medication regimen.

The Compounding Pharmacy of Beverly Hills provides a more individualized approach to medications and can offer easier delivery systems that are gentler on the palate and digestive tract. Contact us today to learn more.

 

 

sourced by Matt Poteet, Pharm.D.

Benefits of Collagen

collagen_supplements_collagen_powder-1024x768Collagen powder has been gaining interest recently. Although it is often thought of as just a beauty product to help with skin aging, the benefits go far beyond.

 What Exactly is Collagen?

This insoluble protein accounts for a majority of  the protein in our body and is found mostly in skin, muscle, bone and connective tissue. It is also rich in the amino acids proline, glycine and hydroxyproline which are not typically present in food. There are 16 types of collagen, with type I, II, III, IV most commonly found throughout the body.

While our body produces collagen regularly, over time lifestyle factors can lead to reduced elasticity in cartilage, tendons, ligaments and skin. This leads to wrinkles, thin skin, joint discomfort and muscle weakness.

What are the Benefits?

Joint pain. As your cartilage weakens and deteriorates with age, you may start to experience stiff, achy joints. It’s possible that upping your collagen intake may help reduce joint pain and alleviate symptoms of arthritis.

In a 2009 study, participants took a type II collagen supplement made from chicken necks for 90 days. Results showed that osteoarthritis symptoms decreased by 40 percent while the severity of symptoms dropped by an impressive 33 percent.(1)

Skin health. This essential protein provides elasticity to the skin, helping it to appear more youthful and healthy. A study published in 2014 randomly chose women, ages 35-55 years old, to take a collagen hydrolysate supplement. They reported an improvement in skin elasticity within four weeks and reduced wrinkles after eight weeks.(2)(3)

Muscle health. Collagen contains a concentrated amount of glycine, an amino acid involved in the synthesis of creatine. Creatine provides muscles with the fuel needed to power through your workout. A 2015 study looked at men 53 and older with sarcopenia (muscle loss) and after 12 weeks of added collagen they saw an increase in muscle mass and fat loss.(4)

Digestive health. Collagen is in the gut’s connective tissue and can help support and strengthen the protective lining of your digestive tract. Any alterations in the barrier function of your intestine, also known as leaky gut syndrome, can allow particles to pass into the bloodstream and result in chronic inflammation.

There is a correlation between low collagen levels and individuals with IBD (inflammatory bowel disease).(5) In theory, increasing your intake of collagen could help build up the tissues that line your gastrointestinal tract and improve overall digestive function.

Where Can You Find Collagen?

If you want to consume collagen naturally, eat a well-balanced, high-protein diet that includes animal products such as beef, chicken, fish and egg whites. Another option is to supplement with collagen peptides. There are many different collagen products and bone broth powders on the market, however many might not reap the benefits. If you’re in the market for a quality collagen, contact The Compounding Pharmacy of Beverly Hills to see how we can help.

 

 

sourced by Brandi Grimmer, LPhT, CNC, Nutritional Consultant

(1)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2764342/

Managing Your Cat’s High Blood Pressure

cat hypertensionAlthough your cat may seem to have little reason for stress or high blood pressure, feline hypertension is a serious yet common health threat to many house cats. High blood pressure in cats can occur without any discernible cause; however, it is typically a symptom of another disease. Hypertension can commonly occur in both kidney disease and hyperthyroidism. Obesity and genetic components can also contribute to the likelihood of a cat developing high blood pressure. No matter the cause, high blood pressure can cause significant harm to a cat if not treated promptly.

Symptoms of Hypertension

If hypertension is not detected through a routine vet checkup, some of the symptoms can include:

  • Circling
  • Disorientation
  • Blindness
  • Dilated pupils
  • Poor appetite
  • Weight loss
  • Seizure
  • Stroke
  • Vomiting

Unfortunately, high blood pressure often does not have any warning signs for owners to watch for. Because of this, it is important to take your cat to the vet regularly. Much like humans, senior cats are particularly vulnerable to hypertension.

Detecting Hypertension

Blood pressure in cats is measured the same way as it is in humans. A small cuff is placed on either the cat’s leg or tail and the reading is taken. Occasionally, a cat will have anxiety while at the vet. This can increase a blood pressure reading, resulting in a false positive. To help prevent this, try to keep your cat calm and still. The standards for cat blood pressure are:

  • 159/95 and below – Normal
  • 160/119 to 179/100 – Hypertension. (Treatment should be administered)
  • 180/120 and above – Severe hypertension. (Immediate treatment should be administered)

Treatment

Fortunately, hypertension is easily manageable if found and treated early. The first step in treatment is determining whether the high blood pressure is being caused by an underlying disease. Once determined, the underlying disease is treated.

Specific treatments for feline hypertension is similar to treatment in humans. In some cases, medication such as an ACE inhibitor and diuretic may be administered. The Compounding Pharmacy of Beverly Hills can customize these medications into a flavored pill that tastes like liver or tuna making it much easier to administer to your cat. Many vets will also recommend a low sodium diet for cats with high blood pressure. With early detection and routine vet care, the prognosis for managing feline hypertension is typically positive.

Unfortunately, your cat can’t tell you when there’s something wrong. Thankfully, your vet can. Routine vet visits are the best ways to prevent illness and ensure your cat is both healthy and happy for years to come.

 

 

 

sourced by CareFirst Specialty

Benefits of Compounding Medication for Patients With Allergies

compounding pharmacistIf you have reactions to certain types of allergens, you have to be very careful about what you consume. The severity of allergic reactions can vary; they can range from a short bout of minor itching to a full-blown episode of anaphylactic shock.

You also have to be very careful about the medication you take. Both pill and liquid forms of prescription and over-the-counter medications contain fillers, binders, and other substances that are made of ingredients, such as dyes, to which you may be allergic. This can make the medication that you need to be taking to get well a potentially fatal treatment.

The Allergens in Medication

There is a wide range of allergens that are commonly found in the inactive ingredients that bind the active ingredients in medication together. Some of the most common allergens include:

  • Gelatin
  • Peanut oil derivatives
  • Wheat
  • Dairy
  • Corn
  • Potatoes
  • Coconut

Are There Allergens in Your Prescription Medication?

The Compounding Pharmacy of Beverly Hills can reformulate a prescription to exclude unwanted, nonessential ingredients, such as lactose, gluten, or a dye to which a patient is allergic. There are currently no federal requirements in place to specify which non-medicinal ingredients may have gluten. As a result, many medications may have any number of allergens as some of their ingredients.

Using a Compound Pharmacy

Filling a prescription at The Compounding Pharmacy of Beverly Hills can be ideal for people with life-threatening allergies and for whom many of the brand-name medications that are commercially available may be dangerous. Physicians can provide prescriptions for compounded medications, which will be created by one of our skilled compounding pharmacists without the allergens and other types of ingredients that can compromise your well-being.

How is it Done?

The pharmacists remove the component of the drug, such as a filler, that contains the allergen and they deconstruct the medication down to its base parts to remake it into a drug that will be safer for you. In certain situations, a compounding pharmacist can combine certain medications that contain an allergen with anti-allergens, like an antihistamine, to eliminate the effects of the offending ingredient.

If you have an intolerance to gluten or are allergic to peanuts or milk, you should take care that any medication you are prescribed does not contain those substances. We create customized drug mixtures that are designed with your allergens and food sensitivities in mind. Contact us today to see how we can compound the medication that will suit your needs.

 

 

 

 

 

Sourced by Arena District RX

Acetaminophen: The Not So Harmless Medication

man-holding-pills-and-glass-water-thumb

Acetaminophen (the active ingredient in Tylenol®) is found in many over-the-counter and prescription medications used to treat pain and fever. Although often considered a “harmless” drug, acetaminophen overdose is the leading cause of acute liver failure in the US. Acetaminophen is frequently found in combination products such as Vicodin® and many cold & allergy medications. It is important to read medication ingredient labels to identify all sources of acetaminophen (which is sometimes called APAP or a variety of names resembling acetaminophen) since overdose often occurs when patients simultaneously take multiple products containing acetaminophen.

The FDA has recommended reducing the maximum daily adult dose of acetaminophen to 3,250 milligrams per day. Healthy adults who have taken the maximum dose of acetaminophen for just two weeks have been found to have liver damage. Drinking alcohol while taking acetaminophen can increase the risk of toxicity since both are metabolized by the liver.

The FDA is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per dosage unit, citing the risk for liver damage. By limiting the maximum amount of acetaminophen in prescription and OTC products, patients will be less likely to overdose on acetaminophen if they mistakenly take too many doses of acetaminophen-containing products.

If you realize that too much acetaminophen has been taken, call 911 immediately. Signs or symptoms of liver damage are often not noticeable for hours or even days and by the time symptoms occur, damage may be severe and could even lead to death.

It’s also helpful to select cough and cold remedies that do not contain acetaminophen, to reduce the risk of accidental acetaminophen overdose.

If you need a medication but can’t take an adequate dose because it is combined with acetaminophen in the commercial product, we can help by compounding a preparation that is acetaminophen-free.

We are here to help if you have any questions. Please call The Compounding Pharmacy of Beverly Hills and speak with one of our friendly pharmacists.

 

 

 

Sourced by Patti Storey

What is Coenzyme Q10?

CoQ10 healthThere is growing clinical interest in the coenzyme Q10 and its health benefits either as a supplement or in its natural state. Also known as CoQ10, this coenzyme is a natural antioxidant synthesized by our bodies and found in almost all cell membranes. These antioxidants are responsible for removing free radicals from our bodies that can damage cells and contribute to aging, as well as heart disease, cancer, and other health problems.

One of the greatest benefits discovered about CoQ10 is its ability to support healthy and strong hearts. CoQ10 supplements have been shown to help patients who have had heart failure and other heart problems. Over time, free radicals can damage the heart leaving it weaker—and CoQ10 can aid in making the heart muscle cells more efficient. Low levels of CoQ10 have even shown a correlation with patients with congestive heart failure.

In addition to helping strengthen the heart, this coenzyme has been shown to increase energy and help fight aging. Because CoQ10 aids in up to 95% of our body’s energy production, it is often used for people who suffer from chronic fatigue syndrome. Deficiencies of CoQ10 are often associated with complaints of low energy or fatigue in patients. Many patients attribute their decreasing energy levels to aging, but new research shows these side effects don’t have to be an unavoidable aspect of aging. Subjects who regularly took Coq10 supplements were able to restore their body’s levels of this enzyme back to optimal levels.

Lastly, CoQ10 has shown to help treat patients with high blood pressure. Although the supplement must be taken over a course of three months, research suggests that there is strong evidence that with supplement use, a significant change in blood pressure was seen. These patients saw a decrease in systolic blood pressure by an average of 12 mm Hg.

Because of the growing research and promising results of this coenzyme, CoQ10 is available in the United States as a dietary supplement. The medical community have more research to do, but are optimistic that it will help patients protect their heart and many other of the body’s processes. CoQ10 is also known as vitamin Q10, Q10, ubiquinone, or ubidecarenone. If you are interested in learning more about this popular supplement, talk to one of our pharmacists. The Compounding Pharmacy of Beverly Hills is committed to helping you live your best life!

 

 

 

Sourced by: SpectrumRX

Six Benefits of Compounded Medications

compounding medications benefitsCompounded medications are made for each individual or pet who provides a prescription from a physician, veterinarian or other medical professional. These special medications are formulated uniquely for the individual patient rather than in mass quantity for any patient who requires the prescription drug. You might wonder how compounded medications can help you to live a healthier life. Here are six benefits of compounding medications:

1. Having Drugs in Lower Dosages

If you need multiple medications for your body, then the prescribed drugs may interact with each other, leading to an overdose situation or unpleasant side effects. However, a knowledgeable compounding pharmacist can determine how to mix your medications to avoid any problems, using information such as your weight and height. Taking your medication in a lower dosage can prevent unpleasant side effects such as nausea or drowsiness. Certain medications that are commercially available at higher doses may have other benefits at lower doses like lower doses of naltrexone which is prescribed by many doctors to treat many conditions including many auto-immune conditions at doses of 0.5mg to 6mg. These doses must be compounded by a compounding pharmacy.

2. Avoiding Fillers and Dyes that Cause Unpleasant Allergic Reactions

When you order traditional prescription medications, the pharmaceutical company that manufactures the drugs may add fillers and dyes that can cause an allergic reaction. To avoid this problem, you can provide information to the compounding pharmacy about the fillers and dyes so that your medication is safer.

3. Making It Easier to Take Numerous Medications

When you have a serious health issue or multiple medical problems, you may need numerous medications each day. Opening bottles and swallowing several tablets or capsules can become time-consuming, and also, you may lose track of what you are taking. With compounded medications, you can avoid this problem, making your life easier.

4. Having Liquid Medications Rather Than Capsules or Tablets

If you have a problem with your mouth or throat, then swallowing capsules or tablets is difficult, leading to additional health problems. A compounding pharmacist can create liquid medications that are simple to swallow alone, or alternatively, you can mix these drugs with water or fruit juice. This benefit is especially helpful for young children who haven’t learned how to swallow tablets and capsules.

5. Having Medications in Larger Dosages

When you have a certain medical condition or are extremely tall or morbidly obese, the amount of medication required for your body can change. Traditional prescription drugs are made for the average-size adult, so if you need a special larger dosage, then you may need to order it from a compounding pharmacy. You will need to provide your medical condition along with your height and weight to the compounding pharmacist for a custom dose that is right for you.

6. Caring for Your Pet’s Health with Compounded Medications

If you have pets, then these animals may also have temporary or permanent health issues that require treatment with medications prescribed by your veterinarian. It isn’t always easy to give a dog or a cat medication, but you can make it easier by ordering compounded prescription drugs for your pets. Rather than encouraging your beloved pet to swallow several medications, you can reduce the number of times that your cats or dogs need the prescribed drugs. Compounding medications for pets can involve changing a strength, adding a flavor, making it into a transdermal gel or a chewable flavored treat. With compounded medications, both you and your pets will have less stress.

Discover the compounding difference for yourself! Contact The Compounding Pharmacy of Beverly Hills to see how we can help you live a healthier and happier life.

 

 

Sourced by: CareFirst RX

6 Ways to Slow the Progression of Alzheimer’s Disease

June_is_Alzheimers_and_Brain_Awareness_Month

Alzheimer’s Disease, the most common cause of dementia, is not a normal part of aging. This unforgiving disease destroys an individual’s mental functions and can create significant emotional stress for the individuals who have it and the people who care about them.

Alzheimer’s is the sixth leading cause of death in the United States. It attacks the brain’s nerve cells, causing loss of memory, trouble concentrating and thinking, and problems with language skills. It can also lead to confusion, frustration and behavioral changes.

Alzheimer’s is a progressive disease, which means it worsens over time. In the early-onset stage of the disease, individuals usually experience minor memory loss. By the time they reach late-stage Alzheimer’s, they may no longer be able to engage in conversation or respond to their environment.

If you or a loved one think you may be suffering from the symptoms of early-onset Alzheimer’s, please speak to your doctor. If you would like help locating a doctor who has experience with evaluating memory problems, search the local Alzheimer’s Association chapter for one near you. This tool can also help you find support groups and educational resources in your area.

While there is no known cure for Alzheimer’s, there are drugs and therapies that can help temporarily slow the worsening of dementia symptoms and allow you to maintain your current quality of life longer. Your doctor can help you identify strategies specific to your needs, but these general tips may also help:

1. Get in the game.

Keeping your brain active through game play is encouraged. Consider trying crossword puzzles, jigsaw puzzles, brain teasers, word games, card games that challenge your memory, or family games that spark creativity.

Work on Jigsaw Puzzles

2. Let the words flow.

Ongoing communication can be very helpful for someone with Alzheimer’s. Even if it’s simply talking about current affairs, discussing books you’ve read, or sharing the latest activities your children or grandchildren are involved in, you are activating key areas of the brain.

3. Document a life.

Actively recording memories in a scrapbook or photo album can help keep memories alive for you and your loved ones. A daily journal or diary for recording thoughts can be beneficial as well.

Create a Scrapbook of Memories

4. Plan ahead.

While you’re still able, it’s wise to get your financial and other affairs in order. Will you need to give someone access to your bank account? Do you have an Advance Healthcare Directive, also known as a Living Will? Have you had conversations with family members about what you want to happen as the disease progresses? Do you have a Last Will and Testament in place? Do you need to give someone Power of Attorney?

5. Stay positive.

Going out with family and friends and participating in activities you enjoy can boost your spirits and help you manage stress. Ask your doctor for recommendations that will improve your physical, mental and emotional well-being.

6. Create an action plan.

Alzheimer’s Navigator, a web tool from the Alzheimer’s Association (www.alz.org), helps you create a customized action plan based on answers you provide to short, online surveys. There are action plans for everything from working with your doctor and understanding care options, to financial planning and caregiver support.

If you have been diagnosed with Alzheimer’s, talk to your doctor about your options for treatments and therapies. Researchers are constantly looking for new ways to alter the course of the disease and help improve your quality of life.

Additionally, remember that you are not alone. You can seek support from those who are going through similar experiences by getting involved in the social network of the Alzheimer’s Association.   And you can find excellent tips for accepting and preparing for the changes that will occur, coping with stress, and building a support team from the Alzheimer’s Association’s Tips for Daily Life.

Sourced by CareSync.com

 

Changes to Compounding Pharmacy Regulations by the FDA

compounding FDA

Accuracy in drug prescriptions has become a priority in recent years, especially with the outbreak of prescription drug abuse. Because of this, more people are turning to compounding pharmacies to ensure that they are receiving the right amount and dosage of prescribed medication. It is in this light that the U.S. Food and Drug Administration (FDA) recently announced updates to existing regulations involving compounding pharmacies.

What You Need To Know About Compounding Pharmacy Policy Updates

The 2018 Compounding Policy Priorities Plan provides a comprehensive layout of how key aspects will be implemented. It includes changes to some proposed policies to make sure that compounded drugs for patients whose needs cannot be met by conventional mass-market drug stores will not cause harm.

As part of last year’s plans and priorities for compounding pharmacies, the FDA encourages more compounding pharmacies to register under the 340B Drug Pricing Program. Facilities covered by this program are able to procure drugs in bulk supply, subject to more stringent safety standards.

The agency deemed it important to focus on the drug’s efficacy while reducing costs so that more compounding pharmacies will meet the higher production standards for 503B outsourcing facilities. As a result, more patients can have access to higher quality compounded medicines.

Additionally, the FDA would like to reiterate that the necessity of compounded medication should only be an alternative to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug. There is a need to examine compounded medications to ensure that copying of existing medications is avoided.

Another goal is to include refining the regulations for communications with the states. This is with regards to the Memorandum of Understanding (between the FDA and individual states) geared towards addressing issues with the ability of the 503A compounding pharmacies to ship across different states lines. 503A compounding pharmacies are smaller facilities that are only able to compound for patient-specific cases.

With the 2018 regulations, 503A pharmacies should be able to ship across state lines provided that more than 50% of their drugs remain within the state.

Similarly, the FDA is allowing the states more time to report issues such as relying on inspection records that would help identify pharmacies that are shipping more than the allowable amount of compounded medications across state lines.

FDA Regulations for Compounding Pharmacies

This plan has been made in pursuit of implementing the federal law of compounding and to advance the FDA’s public health mission. This should help recognize the value of the compounder’s role in providing quality drugs so that patients can have access to the medicines that they need.

The following are the key features of the Compounding Policy Priorities Plan, based on the FDA announcement:

Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities

The Federal Food, Drug, and Cosmetic Act is responsible for two types of compounding pharmacies:

  • 503A: These include state-licensed pharmacies (or compounding pharmacies) that develop compound drugs with patient-specific prescriptions. They are referred to as “503A facilities” or traditional compounders.
  • 503B: This is the new category of compounders that operate according to heightened stator requirements relative to the 503A facilities.

Drugs that are produced by the outsourcing facilities must be compounded in compliance with current good manufacturing practice requirements and performed in an FDA-approved facility subject to risk-based inspections. It is also important for the outsourcing facilities to provide information on the compounded products to the FDA.

The proposed regulations should cover how cGMP requirements should be applied regarding the size and scope of an outsourcing facility’s operations. Therefore, smaller compounders that compound only limited volumes of drugs may decide to register as outsourcing facilities, as a response to these new policies. This would allow them to compound drugs with or without patient-specific prescriptions under section 503B.

Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs

Despite the acceptance of the usage of compounded medications, restrictions on the potential of copying FDA-approved or commercially available products should be put in place. Therefore, the law provisions are aimed to protect both public health and the premarket approval process. These restrictions prevent drug compounding for patients who can already find their medication in FDA-approved products.

Here are some highlights of this particular provision:

  • The premarket inspection should be implemented to safeguard the regulatory standard for compounded drugs, which should only be distributed if no FDA-approved products are available for the patient.
  • Due to the possibility of pharmacy compounding labs copying FDA-approved drugs, this policy is also aimed at protecting conventional drug manufacturers so that they may pursue research and development for the improvement of their existing products. Sponsors are less likely to invest in and seek approval of life-saving medications if compounders could easily develop substitutes that are less expensive.

Regulating Compounding from Bulk Drug Substances

Traditional compounders (i.e. 503A) are allowed to compound drugs in accordance with the FC&C Act using bulk drug substances that comply with the existing United States Pharmacopeia or National Formulary monograph standards. Meanwhile, outsourcing facilities (i.e 503B) may use bulk drug substances to compound a drug that complies similarly with the FD&C Act, if the FDA has determined that there is a clinical need to compound the drugs.

These policies were designed to address the ambiguity involving bulk drug substances by 503A and 503B facilities within the timeframe of substance evaluation before approval for compounding. During this period – for nominated substances consistent with the 503A or 503B interim policies, that is – there will be no clear distinction that a particular drug belongs to either 503A or 503B bulks list.

More highlights regarding this section include the following:

  • With regards to the 503A bulk list, 48 substances were nominated to the Pharmacy Compounding Advisory Committee. The FDA issued a proposed regulation to address 10 of these substances and to create the criteria for evaluating these substances before inclusion to the list.
  • In March 2018, the agency issued a draft that proposes criteria for making clinical determinations to make it possible for the substances to be included in the existing 503B bulk list.

Solidifying FDA’s Partnership with State Regulatory Authorities

The FDA is working closely with state partners to assure that they are able to address the risks that may be presented by compounded drugs. The objective is to focus on FDA resources (for both outsourcing facilities and traditional compounders) that may present huge risks.

Some of the important pointers in this section are as follows:

  • The MOU between FDA and the states regarding compounding under section 503A will be revised as a result of the overwhelming response of the public to the previous MOU draft.
  • The draft MOU states the percentage of compounded drugs that could be shipped interstate by 503A compounders. If a pharmacy distributes in an “inordinate amount”, the state would agree to take action (Inordinate amount denotes at least 30% of all drug products dispensed or distributed in a given month).
  • The new document makes it more flexible for states to enter into the MOU by providing more time to report to the FDA, particularly in identifying inordinate amounts shipped.

Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake

This final guidance covers the following:

  • Provision of a mechanism for outsourcing facilities to assign beyond use dates to repackaged biological products that exceed the default BUDs of 24 hours
  • More flexible approach to support patients and their clinicians
  • Clarification of policies that are applicable to compounding by outsourcing facilities
  • Addition or modification to the list of drug products that cannot be compounded (because the products or their components have been removed from the market either for safety or effectiveness)

Compliance with the regulation should be strictly monitored, particularly ensuring that only sterile compounded medications will reach patients to avoid any potential health risks.

The Compounding Pharmacy of Beverly Hills works to conform to industry standards and policies to ensure that patients are safe. We offer affordable compounding services to patients and prescribers and provide our valued customers with exceptional service to ensure that they receive the best treatment that they deserve.

 

Sourced by: Compounding Pharmacy of America

3 Benefits of Compounding for Weight Loss

weight lossSo, you’re trying to lose weight. With the summer time creeping up on us, you’ll find that most everyone is trying to lose at least a little weight. But the solution to weight loss transcends dieting and exercising. Your struggle with losing weight could be due to issues in your thyroid, your adrenal and your insulin levels.

Compounding medications is a way that can help you counter these issues in your thyroid, adrenal and insulin glands – the issues that are keeping you from being the healthiest version of yourself. Pharmacy compounding is a way of personalizing the dosage of your medicine.

General physicians typically prescribe medications to their patients that are one-size-fits-all. However, you are your own person with unique needs. Not everyone will have the same type of hormone problems that you’re experiencing, and you’re going to need medicine that can meet you where you are.

Three Ways Compounding Can Help You Attain Your Weight Loss Goals

1. Compounding can help with weight loss by maintaining your thyroid levels

Hypothyroidism means that you have low levels of your thyroid hormone, which causes fatigue, fluid retention, constipation, sore joints and muscles, depression, slowed metabolism and weight gain. Besides the actual weight gain side effect of hypothyroidism, you have all these other symptoms that make you too tired or too depressed to physically work off the weight. It causes a lot of problems.

Compounding can help with these issues by supplying your body with a series of natural thyroid hormones. Compounding can, in a way, trick your body into thinking it’s producing the natural thyroid hormones it needs to supply you with energy and heighten your metabolism. General prescriptions for synthetic thyroid hormones make an effort to combat the symptoms of hypothyroidism that lead to obesity, but not nearly to the extent to which natural thyroid hormones can help.

2. Compounding can help with weight loss by restoring your adrenal glands

Similarly, adrenal hormone dysfunction also causes weight gain. Adrenal issues start to appear once people hit middle age. Particularly, a disorder called Adrenal Fatigue leads to many serious health issues such as allergies, autoimmune disorders, cancer and obesity.

Your adrenal glands are partly responsible for turning your carbohydrates and fats into energy, but Adrenal Fatigue stops the transformation process and causes your body to retain the fats. What’s more is that if you’re not feeling like your usual, healthy self, then you’re probably not feeling up to going to the gym to work off some of the weight you’ve gained since your adrenal glands started malfunctioning.

Compounding, creating natural adrenal hormones that are measured according to your unique needs, can help restore your adrenal glands over time to their rightful condition. By supplying your adrenal glands with the hormones they needs to function properly, your body will start processing carbs and fats as energy again, which will not only keep you from gaining more weight, but it will also give you the energy you need to work off the weight that you gained.

3. Compounding can help with weight loss by healing your impaired insulin glands

You might recognize insulin as the gland that is associated with diabetes. Diabetes is a disorder that results when your pancreas stops producing the proper amounts of insulin, which keeps your body from regulating your blood sugar levels the way it’s supposed to. What’s more is that insulin is also what’s responsible for keeping your metabolism at a healthy pace. If your insulin levels are depleted, then your metabolism will plummet as well, causing you to gain weight.

Hormone therapy that results from pharmacy compounding can be the weight loss solution you’ve been waiting for. By restoring your body’s insulin levels to their rightful condition, you’ll be able to process blood sugars the way that you’re supposed to, which will cause your metabolism to go up. This will not only keep you from gaining more weight, but it will also help you lose weight during the process, without lifting a single dumbbell or running a single mile.

Lose Weight Through Compounding Today

The Compounding Pharmacy of Beverly Hills specializes is compounding hormone therapy that can help you on your unique journey to the healthiest and happiest version of yourself. Not only can we specifically aid you in your efforts to rectify your thyroid, adrenal and insulin glands, but we can also help you with other compounding efforts to help you lose weight in general. Contact us today to get started on your journey to weight loss.