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.

Compounding for Bad Breath

CPBH Of course, you can have bad breath (halitosis) after you eat onions or garlic, but chronic bad breath is usually caused by the buildup of bacteria or yeast/candida within your body. Bad breath can also be caused by disease, gastrointestinal and/or upper respiratory tract disorders, buildup on your tongue, dry mouth or dental plaque.

To eliminate bad breath, you have to eliminate the cause. Bacteria, yeast and candida feed off sugar and grains. Modify your diet to eliminate sugar and processed foods. Eat probiotic-rich foods like kefir, sauerkraut, kimchi, kombucha, and more healthy fats like coconut oil. Also add a high quality probiotic supplement to restore good bacteria in your gut.

Dry mouth (xerostomia) also can cause bad breath. Several medication may cause dry mouth as a side effect. Saliva is needed to moisten the mouth, neutralize acids produced by plaque on teeth, and wash away dead cells that accumulate on the tongue, gums, and cheeks. If not removed, these cells decompose and can cause bad breath. Drinking at least eight eight-ounce glasses of water per day can help.

Due to its effectiveness against bacteria known as anaerobes, which have the greatest odor potential, the antibiotic metronidazole has been used for treating bad breath associated with ulcerative gingivitis and periodontal disease. A single dose of one tablespoon (15 ml) of metronidazole mouthwash used as a rinse for 5 minutes and then expectorated (spit out) can reduce halitosis significantly by decreasing bacterial counts on the tongue surface. Metronidazole mouthwash may be an option for hospice patients or other patients who suffer from malignant ulcers of the mouth, since the ulcers are often associated with anaerobic bacteria. However, metronidazole mouthwash should not be used to treat bad breath in otherwise healthy people since its use could increase the risk of antibiotic-resistant strains of bacteria.

If you suffer from bad breath or other health problems that have not responded to traditional care, talk to our pharmacists to see how we can help.

 

Sourced by: Pattie Storey

Curing Insomnia

InsomniaWhat is Insomnia?

Insomnia is a condition where an individual can have a difficult time falling asleep or staying asleep. 30-40% of Americans have sleep issues each year. When sleep disorders last longer than one month, they are classified as a chronic sleep disorder. Scientists do not know why we sleep, but the lack of sleep can affect our mood, our physical wellness, and our overall happiness. REM sleep is the time when we tend to dream, and we should have several episodes of REM sleep each night. Failure to reach REM sleep will have a negative effect on regenerative hormones that are produced while we sleep.

The Natural Sleep Hormone – Melatonin

Melatonin is secreted at night when darkness is approaching and it causes us to become sleepy and lowers our body temperature. Many prescription medications can block the production of Melatonin. You can ask our pharmacists if the medications you are taking may be depleting Melatonin, making it difficult to fall asleep.

There are also lifestyle changes one can enact to improve the quality of sleep. If you have sleep issues, you should first examine the amount of caffeine you are consuming, especially at night. Alcohol will cause poor sleep, especially if taken in excess. To stimulate the production of Melatonin in the evening you should turn your lights down. Staring at computer screens, video games, or television just before bedtime can make Melatonin production difficult. Exercise can improve the quality of sleep, and eating meals too close to bedtime can adversely affect sleep.

Many individuals turn to prescription medications to try to address sleep disorders. However, these medications can become problematic as they can adversely affect the normal sleep cycle, especially the REM sleep cycle. We recommend starting with a quality sleep supplement to help restore the natural sleep rhythm. Magnesium is a mineral that acts as a calmative and helps our muscles relax, helping us to fall asleep more easily. Combinations of sleep-inducing ingredients such as magnesium, Melatonin, Valerian root, passionflower, and L-Theanine can induce a natural sleep onset. L-Theanine is a unique amino acid that acts as a calmative for us when taken during the day, but can help to improve sleep when taken at bedtime. L-Theanine is especially useful for those individuals who only sleep 4-5 hours a night.

If you have sleep problems, we invite you to ask our pharmacists for safe and effective recommendations to help you restore your natural sleep cycle.

8 Facts About Heart Health

heart diseaseFebruary is National American Heart Month which makes it a great time to raise awareness about heart disease and other heart-related issues to ensure that your heart stays healthy for years to come.

Studies show that heart disease is the leading cause of death for Americans. Therefore, it’s vital to educate yourself on how to lower your risk. Keep the following heart-related facts in mind this month so you can learn healthy habits for the future.

1. Ten Minutes of Exercise Helps Your Heart

Simply ten minutes of physical activity each day can lower your risk of having a heart attack significantly. Aiming for thirty minutes a day could potentially lower your risk even more.

2. Less Screen Time is Heart Healthy

If you tend to spend four or more hours per day sitting in front of your TV, computer, laptop or other device, your risk of having a heart attack is almost double. Limit screen time and spend more time on your feet to reduce this risk.

3. Heart Disease Starts Early

Heart disease isn’t something that develops when you’re older. In fact, it starts when you’re a teenager or young adult. Being obese during childhood can make the risk of having heart disease even higher when you become an adult.

4. Stress and Heart Disease Go Hand in Hand

Stress is one of the biggest factors that leads to heart disease. Find ways to reduce stress, such as deep breathing. Learn to keep your anger in check in order to lower your risk of having a heart attack.

5. More Sleep Is Better for Your Heart

Those who get more sleep each night have a lower risk of heart disease. Women who get less than five hours of sleep, have a 39 percent chance higher of having heart disease.

6. Laughter Protects Your Heart

Laughing is healthy for your blood vessels. It helps them relax and expand, which keeps your heart working properly.

7. Heart Disease Fatality Rates Are High

Heart disease fatality rates are around 40 percent, which is higher than deaths associated with all types of cancer. More than 25,000 people in the U.S. die from heart disease every day.

8. Age is the Biggest Risk Factor

Although heart disease can start when you are young, age is the biggest risk factor. Other risk factors include high blood pressure, high cholesterol, diabetes, smoking and a sedentary lifestyle. Even though you can’t control certain risk factors, such as a family history of heart disease, making healthy lifestyle changes can help reduce your risk overall.

If you want more information on how to keep your heart healthy, contact The Compounding Pharmacy of Beverly Hills. We can also help you out if you are on different medications and are interested in prescription consolidation.