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Our Compliance

Although we do offer patient-specific medications through our 503A facility, we also offer an FDA outsourcing facility (also known as a 503B facility, which refers to the filling of “office-use” or “office-administered” medications). Because the FDA created this new designation of compounding pharmacy to establish a new level of patient care and safety, outsourcing facilities like Olympia are required to comply with strict cGMP (current good manufacturing practices) guidelines, which have the same standards that pharmaceutical manufacturers follow. Olympia Compounding Pharmacy is the only outsourcing facility in Central Florida.

 

Our Industry Expertise

The national leader in compounded medications with more than 35 years of expertise, our team at Olympia Compounding Pharmacy is a trusted referral source for patients seeking specialty therapies. Our team is made up of Pharmacy Technicians, Pharmacists, MicroBiologists and Engineers, creating a diverse and wide-reaching level of expertise.

 

Our Variety of Services and Products

We are a full-service pharmacy offering traditional, OTC and compounded medications with an extensive inventory of compounded chemicals and traditional medications. Our staff is educated and experienced in all facets of pharmacy and our buying power results in lower prices on retail and compounded medications.

Our specialties include:

• – Testosterone Replacement Therapy for Men
• – Bioidentical Hormone Replacement Therapy for Women
• – Medical Weight Loss / Weight Management
• – Erectile Dysfunction Solutions
• – IV Nutrient Therapy
• – Female Sexual Health

 

Our Accessibility

Shipping is offered directly to your patients or your office. We offer next-day delivery to most of Florida and the majority of our compounded prescriptions are available the same day. We also offer an automated prescription refill service as well as a “Meet or Beat” price policy for shipping.

Plus, of the nearly 56,000 community-based pharmacies in the nation, only around 7,500 specialize in compounding services. Of those, less than 80 are FDA approved. As one of the few 503B compounders, Olympia is an essential resource for bridging the gap during a drug shortage.

 

Our Partnership

Olympia offers many opportunities and programs for physicians to develop and grow their patient base. During an online meeting, one of our specialists can explain Olympia’s programs and walk you through a visual tutorial on your computer.

If you’re looking for patient-specific medications, our 503A facility offers:

• – Individualized and patient-specific medications
• – Formulations adjusted to meet specific treatment needs
• – Enhanced patient care
• – Multiple dosage forms

We are committed to providing the best in compounded medications to both providers and patients alike. Learn more about our 503A and 503B facilities and what they have to offer you.

 

Ready to talk to a specialist? Contact us now!

Contact Olympia

What Is an FDA Outsourcing Facility?

In 2013, The U.S. Food and Drug Administration signed into law The Drug Quality and Security Act, which created a new section called 503B in the Federal Food, Drug and Cosmetic Act (FDCA). This act enables a compounding pharmacy to become a 503B outsourcing facility.

The legal definition of a 503B outsourcing facility is: a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

A compounding pharmacy must elect to register as a 503B outsourcing facility, pay an annual registration fee and meet specific conditions in order to qualify as exempt from the FDCA.

 

What Does an FDA 503B Outsourcing Facility Do?

According to the FDA, an 503B outsourcing facility is one that:

• – Compounds sterile drugs (although it may also compound non-sterile drugs as well)
• – Has chosen to register itself as an outsourcing facility
• – Has complied with all of the regulations required within section 503B
• – Must conduct all compounding by or under the direct supervision of a licensed pharmacist, although it’s not mandatory for the facility to be a licensed pharmacy
• – May or may not obtain prescriptions for identified individual patients

 

FDA 503B Outsourcing Facility Requirements

• – An outsourcing facility must comply with current good manufacturing practice (CGMP) requirements
• – All compounded drugs must be compounded under the direct supervision of a licensed pharmacist within the facility
• – All compounded drugs must be inspected by the FDA

503B outsourcing facilities must also report on information about all products compounded on location, including:

• • * A list of all products compounded in the past six months
  • * The source of the ingredients of those products
  • * Adverse events that occur

 

What Are the Benefits of a 503B Outsourcing Facility?

• – Good for Office Use: 503A compounding pharmacies are designed to dispense for home use, while 503B outsourcing facilities may manufacture for office use.
• – Frequent Monitoring: Environmental monitoring must be performed per production shift in primary compounding areas and weekly in secondary compounding areas.
• – Quality Control: 503B outsourcing facilities are required to maintain their own quality department as its own autonomous entity to conduct investigations.

 

How Can I Find Public Info About 503B Outsourcing Facilities?

For additional information about outsourcing facilities that’s been reported to the FDA over the past two years, visit the Outsourcing Facility Product Report searchable database.

 

Key Takeaways

• FDA Outsourcing Definition: An FDA 503B outsourcing facility is a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.
• FDA Requirements for 503B Outsourcing Facilities: An outsourcing facility must compound drugs under the direct supervision of a licensed pharmacist within the facility, have their compounded drugs inspected by the FDA and comply with (CGMP) requirements.
  
• Benefits of a 503B Outsourcing Facility: they are good for office use, and require frequent monitoring and quality control.

 

Are you a provider looking to learn more about how our facility can help grow your practice? Contact us today to get started.

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Understanding 503B Pharmacies

Olympia Compounding Pharmacy understands the importance of providing both patient-specific and office-use needs across the country. That’s why we’re equipped with two separate, state-of-the-art facilities — one to fulfill 503A compounding pharmacy needs and the other for 503B.

But let’s explore more of what a 503B FDA outsourcing facility actually is. Here are the main distinctions:

• – 503B pharmacies are the only compounding pharmacies that are able to provide office-use (or “office-administered”) medications. Outsourcing facilities are sometimes referred to as 503B facilities.
• – A 503B pharmacy is a designation created by the FDA that establishes a new level of patient care and safety.
• – 503B pharmacies must comply with strict CGMP (current good manufacturing practices) guidelines, the same standards pharmaceutical manufacturers are held to.

These 503B outsourcing facilities are the only pharmacies permitted to provide compounded medications for use in physicians’ offices, clinics and hospitals.

What Is a 503B Pharmacy?

The FDA carefully regulates the quality of compounded pharmaceuticals. The Compounding Quality Act, passed in 2013, defined a new designation of compounding pharmacy, called a 503B Pharmacy.

A 503B pharmacy is directly regulated by the FDA using CGMP regulations. CGMP regulations are the same ones followed by pharmaceutical manufacturers. Therefore, a 503B pharmacy is a compounding pharmacy that operates under CGMP guidelines, which are very stringent.

Additional benefits of 503B pharmacies include:

• – 503Bs test every batch of medication for endotoxin, sterility and potency
• – 503Bs can offer extended beyond-use dates because of the rigorous testing performed under CGMP

For TriMix injections, see why it’s important to obtain your medication from an FDA-approved 503B compounding pharmacy like Olympia.

What Are the Benefits of a Compounding Pharmacy?

Of the approximate 56,000 community-based pharmacies in the U.S., about 7,500 pharmacies specialize in compounding services, and of those, less than 80 are FDA-approved. This means the pharmacists in 503B compounding facilities are fully dedicated to compounding special preparations for patients and have made the investment in equipment and training to do so safely and efficiently.

The preparations offered by compounding pharmacies can be non-sterile (ointments, creams, liquids or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (intramuscular injection, intravenous and eye drops).

How Are Compounded Medications Used?

Your healthcare provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. Many specialties utilize compounding for more individualized patient care. Some of the specialties Olympia compounds medication for include medical weight loss, HRT for men and women, erectile dysfunction, female sexual health, vein care and IV nutrition.

At Olympia Pharmacy, we understand that health and wellness needs can vary from person to person. Because no two bodies are exactly alike, we offer tailored medication solutions designed to meet a wide range of patient requirements. Our approach is grounded in delivering options that align with your individual body chemistry and treatment goals.

What Are Olympia’s Quality Assurance Procedures?

As an outsourcing facility, Olympia adheres to detailed safety requirements before compounding even begins, making us an industry leader in safety, compliance, quality and customer satisfaction. Each day, air and surface samples are taken in each clean room. Each technician is fully gowned and participates in fingertip testing before entering the compounding environment.

When a batch of medication is completed, it’s placed in a special quarantine area while samples from the batch are sent off for independent, third-party laboratory testing. Independent lab tests are performed for sterility, endotoxins and potency. This testing normally takes 14 days to complete. When the tests come back satisfactory, the medications are then released from quarantine and are available to be dispensed to patients or physician/clinic offices.

The procedures and guidelines we follow make an outsourcing facility, by far, the safest place to obtain medications from. Because these rules are so stringent, only a handful of compounders in the United States have elevated their pharmacies’ to the new FDA outsourcing facility designation. Olympia Compounding Pharmacy is currently the only outsourcing facility in Central Florida.

Key Takeaways

• – 503B pharmacies were created as a result of the Compounding Quality Act with the main purpose of offering safe compounded medications that would otherwise be commercially unavailable.
• – A 503B pharmacy is a designation created by the FDA that establishes a new level of patient care and safety.
• – 503B pharmacies are the only compounding pharmacies that are able to provide office-use (or “office-administered”) medications.
• – 503B pharmacies must comply with strict CGMP (current good manufacturing practices) guidelines, the same standards pharmaceutical manufacturers are held to.
• – 503Bs test every batch of medication for endotoxin, sterility and potency.
• – 503Bs can offer extended beyond-use dates because of the rigorous testing performed under CGMP.

Now that you know more about 503B pharmacies, learn more about the other half of our business: our 503A pharmacy and how Olympia uses both designations to help our customers comply with all national and state regulatory requirements while using a single-source pharmacy partner.

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Vitamin IV Therapy: The Basics

If you’ve recently wondered “What is vitamin IV therapy anyway?”, here’s your source for information. Vitamin IV therapy (a.k.a. IV therapy, IV nutritional therapy, IV nutrient therapy, IV nutrition and intravenous therapy) is a popular type of therapy used for a variety of health benefits. Traditionally, this type of IV therapy has been used to complement patients undergoing cancer care, which was designed to help enhance their health during treatment.

What Is Vitamin IV Therapy Used For Today?

Today, it’s used more commonly for patients striving for improved health, whether that be to help avoid the next flu virus or simply to have more energy throughout the day. In a perfect world, we’d all drink enough fluids and get the appropriate nutrients we need every day. However, that’s not always an attainable goal to achieve. Because of this, many people depend on a solution that can help complement a good diet and proper hydration for living as our healthiest selves.

IV vitamin therapy can be very helpful in supporting a healthy, nourished body. Common uses for vitamin IV nutritional therapy include:

• – Age Management
• – Immune System Enhancement
• – Illness Prevention
• – Energy Boost
• – Detoxification
• – Artery Cleansing
• – And More

Possible Benefits of IV Nutrition:

• – Boosts energy
• – Detoxifies the body
• – Enhances the immune system
• – Helps prevent illness
• – Decreases artery plaque
• – Combats chronic fatigue
• – Improves the effects of hangovers
• – Reverses symptoms of malnutrition
• – Assists with age management
• – Helps treat Parkinson’s disease

What Nutrients Are Administered?

IV nutrition includes a variety of vitamins, minerals, antioxidants, and other nutrients that work together to support overall wellness. Treatments are delivered through an intravenous drip, with each formulation selected based on the patient’s specific goals and health considerations.

Some common infusions used include:

• – Amino acids
• – Ascorbic Acid
• – Glutathione
• – B Vitamins

At Olympia Pharmacy, we offer several IV nutrient therapy solutions that may support energy levels, immune function, recovery from illness, and symptoms related to fatigue or nutrient deficiencies. As an IV pharmacy, Olympia also provides pre-formulated kits to make it easier to begin IV therapy.

How Is IV Nutritional Therapy Performed?

Vitamin IV therapy involves delivering a blend of vitamins, minerals and other nutrients directly into the bloodstream, allowing for faster absorption compared to oral supplements. This treatment is administered in a medical setting under the supervision of a trained healthcare professional. IV nutrition formulas can be selected based on individual goals and health considerations, and should always be discussed with a physician before beginning treatment.

At Olympia, we offer a variety of IV kits that are designed to address different things. We offer:

• – Brainstorm: May improve overall brain function, increase memory recall and certain aspects of learning
• – Immunity: May strengthen your immune system and feel better faster
• – Myer’s Cocktail: May reduce seasonal allergies, fatigue, and inflammation, and restore natural balance
• – Timeless: May reduce the appearance of aging by promoting collagen production, cellular regeneration and oxidative stress reduction
• – Recovery & Performance: May decrease recovery time and enhance your athletic performance
• – Get-Up-And-Go: May burn fat, feel energized and boost your metabolism
• – Alleviate: May reduce bloating, irritability, abdominal discomfort and more
• – Quench: May help hydrate and combat fatigue
• – Reboot: May help combat hangover-related symptoms like dehydration, headache and nausea

In addition to pre-formulated kits, Olympia also offers individual IV nutritional therapy medications that can be selected and combined to align with specific treatment goals.

How to Get Started with IV Nutritional Therapy

To learn how to offer this service at your medical practice, choose Olympia to be the IV pharmacy to get you started. Contact us today to learn more.

Contact an IV Nutrient Therapy Expert

For nearly 20–25 million Americans, varicose veins are a common condition—especially for those who spend an excessive amount of time sitting or standing, or for those who are obese, elderly, smokers or pregnant.

Thankfully, symptoms of varicose veins are usually very mild. Although there is some swelling and aching, these veins are mostly just an eyesore with little to no real health threat associated with it.

What Causes Varicose Veins?

When we sit or stand for too long over an extended period of time, it becomes harder for our veins to fight back gravity to get blood flowing back up to the heart. This can cause valves to malfunction and create a backflow of blood—typically the ones located in legs and feet. That’s how the appearance of these superficial varicosities begins to surface.

At-Home Remedies

Here are some quick fixes that may help with the appearance of varicose veins:

• Elevate legs to heart level (multiple times per day)
• Wear compression socks (knee-high stockings are best)
• Exercise (walking, swimming, ankle flexion, etc.)

Vein Sclerotherapy

For those who are looking for a more immediate solution to treat the symptoms of varicose veins (as well as spider or reticular veins), a minimally invasive option is sclerotherapy.

Sclerotherapy is a commonly used treatment that can be performed in a physician’s office in just a few minutes. The procedure involves injecting sclerosing agents, such as Polidocanol or Sodium Tetradecyl, into the affected veins, which causes them to collapse and gradually fade. Most patients are able to resume their normal activities shortly after the procedure.

Here are some of the main reasons why sclerotherapy is a popular option for treating varicose veins:

• – Minimally invasive
• – Quick in-office procedure
• – Little to no downtime
• – Frequently used by physicians to address visible or symptomatic veins

Learn more about sclerotherapy online or contact us today to find the vein therapy solution that best suits you.

Contact a Sclerotherapy Expert

More than 93 million American adults were affected by obesity in 2015 and 2016 — averaging at nearly 40% of the nation’s total population. And with numbers continuing to trend upward, many physicians and clinics have started offering medically supervised weight-loss options to help combat this growing issue.

What Is It?

Let’s start by answering an initial question: What is medically supervised weight loss? The main answer is that it can vary depending on the physician or clinic, but generally speaking, it’s a physician-monitored program that includes a custom diet plan and exercise schedule designed to help patients lose weight, motivate them, and promote healthier lifestyles. It’s typically coupled with a metabolism enhancer or vitamin consumable that complements their weight-loss plan.

Who Is It Right for?

If you’re unsure if you suffer from obesity, ask your physician. In the meantime, you can also assess any symptoms related to obesity that you may be experiencing, such as extreme daily exhaustion, increased sweating, inability to handle sudden physical activity, back or joint pain, loss of breath, etc.

Medically Supervised Weight Loss Treatments

In addition to diet and exercise, a physician or clinic may prescribe a compounded medication like B12 or another similar fat-burning injectable that helps to further encourage weight loss.

At Olympia, we offer several treatment options, including:

• – Lipo-Mino Mix
• – Vitamin Injectables
• – Olympia’s Weight Loss Kit

Benefits of Treatment

Now for the answer to another important question many people ask when considering treatment: What is medically supervised weight loss going to do to benefit my health?

After a physician has prescribed a medically supervised weight-loss treatment that’s right for you, you should notice significant health benefits, including:

• – Lowered blood pressure
• – Decreased joint and back pain
• – Improved heart health
• – Improved sex life
• – Increased self-confidence
• – And more

You can learn more in our guide to medically supervised weight loss.

How To Get Started

Whether you’re a patient or a physician interested in a weight-loss program, Olympia has treatment options for you. To learn more about our weight management solutions, contact a weight-loss specialist today.

Contact a Weight-Loss Specialist

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What Is Andropause?

Some men entering their 50s (or older) experience a noticeable drop in their testosterone levels—something called andropause, or more commonly: “male menopause”.

Andropause is a condition unlike female menopause in that it happens more gradually and it doesn’t affect all men—about 30% are affected by it by the time they reach their 50s. It can cause many different symptoms—not just sexual, but physical and psychological ones as well.

What Causes Andropause?

Any case of andropause is caused by one main factor: lack of testosterone. As men get older, the testes start producing less and less testosterone, causing a gradual drop in overall testosterone levels. This is caused by a decrease in the hormones that actually alert the testes to produce testosterone, as well as an increase in the amount of testosterone that’s converted into other hormones like estrogen and dihydrotestosterone.

Another factor can be due to an increase in sex hormone-binding globulin (SHBG), which is a protein that testosterone clings very tightly to. It’s a protein that becomes more prevalent in men as they age.

Symptoms of Andropause

Although symptoms of andropause can vary in type and severity, the most common are:

• Problems with achieving and/or maintaining erections
• Lower sex drive
• Inability to concentrate
• Decreased motivation and energy
• Insomnia or difficulty sleeping
• Moodiness and irritability
• Lowered self-confidence
• Loss of muscle mass
• Depression
• Weight gain
• Gynecomastia
• Infertility

How Is Andropause Diagnosed?

First, a doctor will assess the person’s symptoms to see if they match with common symptoms of andropause. Then, once a blood test is taken to check their testosterone levels, a diagnosis can be made if the results are below normal.

Treatment Options for Andropause Symptoms

The first recommendation for treating symptoms of andropause is making changes to improve your lifestyle choices. This may include:

• Eating healthier foods
• Exercising more regularly
• Getting more hours of sleep each night
• Finding ways to reduce current stresses

If these are not applicable or are not currently an issue, testosterone replacement therapy (TRT) may be a viable option to consider. This type of therapy does require a prescription and monitoring by a licensed physician, but if your doctor believes testosterone replacement therapy is right for you, Olympia Pharmacy offers several great treatment options, including:

• Intramuscular testosterone injections
• Transdermal cream in a convenient pump or Topi-CLICK® delivery system
• Sublingual tablets that dissolve quickly under the tongue  

To learn more about Olympia Pharmacy’s testosterone replacement therapy options, fill out our testosterone therapy request form and our team will contact you shortly.

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