What is a Compounding Pharmacy?
A compounding pharmacy specializes in preparing patient-specific medications in collaboration with a practitioner to meet a medical necessity of a patient. A compounding pharmacist may change the route of delivery, the dosage form, and/or the strength of medication to properly administer a medication to a patient that has special needs. One medication dosage or strength does not always fit the needs of every individual, and big pharmacy simply does not specialize in these individual cases because of the way they mass produce drugs.
Beyond the additional therapeutic benefits of a compounded medication, these pharmacies or pharmacists can pull any non-essential dyes or potential allergens from medications or even preservatives to better suite a patient need. These modifications directly complement preventive care treatments because they can be optimized for your individual patient.
Why Would I Want to Use a Compounding Pharmacy?
The customization of medication is one of the major benefits of compounding pharmacies. They can add inert ingredients to medications that allow for superior absorption, slower release that will ultimately lead to improved therapeutic outcomes, and better patient compliance.
Beyond their capability to prepare customized medication for your patients, the medications these pharmacies provide are often available for a fraction of the cost of commercial options. Additionally, as a physician, you may offer non-controlled medications through a 503B compounding pharmacy for in "office use". This removes the traditional pharmacy component and the use of insurances.
What is the Difference Between a 503A and 503B Compounding Pharmacy?
It’s important to understand that for 503A or State regulated medications, all prescriptions must be patient-specific. They must also display all demographics of the patient clearly on the prescription. When prescribing medication from 503B pharmacies, physicians may write prescriptions for “office use” (except when ordering a controlled substance) and medications are shipped to the office.
The primary difference between compounding pharmacies 503A and 503B are whom they are regulated by. There are both 503A and 503B pharmacies in the EC3Health partnership to best serve you and your concierge or hybrid medical practice.
A 503A pharmacy is governed by the regulations of the state in which it is located. And a 503B pharmacy, which is also called an FDA outsourcing facility, is directly regulated by the FDA. Both 503A and 503B pharmacies have slightly different guidelines they must adhere to, except when it comes to controlled substances.
Here’s a quick breakdown of the above information:
|Regulatory Agency||By State||By FDA|
|Compliance Laws||USP 795 non-sterile & USP 797 sterile||CGMP’s|
|Prescription Information||Must be patient specific and contain patient demographics||Patient specific or office use|
|Delivery||Patient’s Home||Office Use|
*Controlled substances are regulated by the DEA and must be shipped to the patient.
Controlled substances are regulated by the DEA and require that prescriptions must be patient-specific and written with full patient demographics as well as shipped directly to the end user’s home. Laws regarding controlled substances apply to both 503A and 503B pharmacies.
Regarding the differences in oversight – 503A pharmacies must adhere to USP 795 non-sterile and USP 797 sterile regulations. 503B pharmacies must adhere to CGMP’s as dictated by the FDA and that similarly apply to drug manufacturers.
Why Should I Use EC3Health’s Compounding Pharmacy Partners?
Our pharmacies have been vetted by our pharmaceutical experts, and we’ve established long-lasting and trustworthy relationships with them. After working with and comparing hundreds of compounding pharmacies across the country, we have vetted and selected the absolute best compounding pharmacies available.
Our team personally inspects each compounding pharmacy to ensure they are going above and beyond the baseline requirements. We verify they are adhering to all state and federal regulations, as well as all quality assurance and testing protocols. In particular, testing all sterile injectables for potency, stability, endotoxins, and sterility.
Our team of experts are pharmacists and medical doctors as well as CGMP specialists who have backgrounds in pharmaceutical compounding – meaning they are at the forefront of regulatory data and current best practices.
We welcome and encourage of our practitioners to come down to Florida and meet with us and our pharmacy partners at any time for a grand tour of our compounding pharmacies. We would be delighted to have you visit and meet the team of pharmaceutical experts who truly care about providing you the best quality compounded medications.
What Does “Office Use” Ordering Mean?
"Office use" ordering is when a physician orders a medication that is sent to the practice office and is ordered for "office use" on a prescription. Typically, these medications are then administered or mixed in the office by the physician or staff.
Are These Compounded Medications Tested by a Third-party Laboratory?
Absolutely. All non-sterile and sterile compounded medications prepared by our pharmacy partners are required to meet all State and Federal regulations set for non-sterile and sterile compounded preparations.
What are My State’s Requirements Regarding “Office Use” Versus “Patient-Specific” Ordering?
EC3Health’s pharmacy network includes all 50 states. This means no matter what State your practice is in, we can ship compounded medications to either your practice or your patient directly.
Your State determines whether you can ship to your practice office or if you will need to ship directly to your patient. Every state has different laws regarding whether medication can be written and shipped for “office use” or “patient-specific” ordering.
Below are states that allow both office use and patient-specific use through our 503B pharmacy partner:
There are a few states that simply do not permit office use ordering including:
If you have any questions regarding your state regulations, feel free to contact us and we can help you determine your state’s requirements.
What are My State’s Requirements Regarding Ordering Controlled Substances?
All controlled substances are regulated by the DEA. Our pharmacy partners adhere to all regulatory guidelines when ordering medications. Controlled substances must have patient- specific prescriptions and are delivered to the patient directly.
EC3Health’s pharmacy partners takes regulatory compliance one step further and ensures you are compliant along the way. When setting up your pharmacy account and potentially using our on-line ordering system, we check both your DEA and State license information to make sure it is up to date, and we acquire your signature on file, to protect you and our pharmacy partners from potential fraud or abuse.
We protect the legitimate practitioners we collaborate with. And we make it our business to protect the concierge medicine model, and to promote its future success.
Can Testosterone or Other Controlled Substances be Shipped to my Office?
No. Compounded medications containing controlled substances must be shipped to the end user whether it’s a home address or work place.
How Can I Find Out What Medications are on Backorder or Discontinued?
For a complete and up-to-date list of unavailable or discontinued medications, please visit the FDA website. You can find information regarding drug approvals, safety and availability, guidance, compliance, and regulatory information there. If you still have questions after visiting the FDA website, feel free to contact us and we’ll point you in the right direction.
If you are already an EC3health practitioner interested in finding out what medications are on backorder from an individual pharmacy partner, please email or call us directly.
What’s The Cost of Your Consulting Services?
As a comprehensive physician-to-pharmacy liaison, we have leveraged the purchasing power of our network in order to pass on the cost savings to our physicians. Additionally, compounding pharmacies don’t typically have the time for partner outreach, which is where we come in.
We are passionate about bringing physicians and pharmacies together to improve patient care and physicians’ lives. Once you join the EC3Health network, there is no additional cost for our pharmacy consulting services.
Additionally, we do offer additional marketing support and medical training at a low cost – and the ROI is HUGE for our practices.
By offering consultations and our expertise as part of joining our partnership, is yet another way we make concierge medicine a possibility for physicians and remain true to our mission.
What Therapies Does EC3Health offer Training and Support In?
We have identified 10 therapies that are both beneficial to patients and are a good return on investment for practitioners. These include:
- Weight loss and the hCG diet
- Hormone replacement therapy for men
- Hormone replacement therapy for women
- Age management therapies
- Hair rejuvenation
- Pellet therapy
- IV therapy
- Lipotropic therapy
- Erectile dysfunction therapy
- Aesthetic therapies
To find out more about these therapies please call or email us with your questions.
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