Town & Country (503A) Compounding Pharmacy
The Gold Standard of Care During the “Tirzepatide Turbulence”
The conversation around compounding pharmacies has gained heightened attention in the current landscape of medication shortages and evolving healthcare needs. The FDA’s recent, abrupt removal and subsequent reinstatement of access to compounded tirzepatide injections (GLP-1) underscores the essential role that 503A compounding pharmacies play in facilitating patient access to essential medications in shortage.
503A compounding pharmacies are the type of pharmacies that are the most highly qualified to provide compounded sterile injectable medications directly to patients, especially during shortages.
Unfortunately, amidst the “tirzepatide turbulence” caused by the FDA, some false narratives have somehow conflated reputable compounding practices with unregulated gray market operations, leading to misconceptions about the integrity of licensed pharmacies. 503A compounding pharmacies are highly qualified to make sterile GLP-1 injections such as tirzepatide and semaglutide.
503A compounding pharmacies should absolutely not be compared to or confused with medspas, medical practices or others who are doing “backroom unregulated compounding with gray market, untested powders from China.”
The high qualifications and strict regulations of 503A compounding pharmacies: such as Town & Country Compounding
Not all pharmacies uphold the same standards. Our accreditations place us in the top 1% of compounding pharmacies.
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Take a tour of our high-tech sterile compounding labs.
Where you get sterile compounded medications makes a big difference in health outcomes.
Unlike commercial drugs from a retail pharmacy (that will have the same quality no matter where you buy them), the quality and effectiveness of compounded medications can vary widely from pharmacy to pharmacy.
Pharmacists must complete a rigorous six-year pharmacy education program, which is often followed by additional specialized training in compounding. Their education equips them with a deep understanding of pharmacology, calculations, chemistry, and the complex processes involved in medication preparation.
503A compounding pharmacies operate under strict regulations set forth by state boards of pharmacy, ensuring that all practices adhere to high quality and safety standards. Moreover, to achieve and maintain PCAB accreditation (Pharmacy Compounding Accreditation Board), Town & Country Compounding undergoes thorough inspections to verify compliance with these stringent standards. Additionally, our compounding technicians have extensive training, ensuring they possess the necessary skills and knowledge, with many years of experience in sterile compounding practices.
503A compounding pharmacies are heavily regulated and routinely inspected by numerous authoritative bodies, including state boards of pharmacy, the National Association of Boards of Pharmacy (NABP), and the Pharmacy Compounding Accreditation Board (PCAB). Town & Country Compounding Pharmacy labs adhere to stringent standards that ensure the safety, quality, and efficacy of the medications we compound for patients.
A state-of-the-art sterile compounding environment in 503A pharmacies
It’s an odd misconception that compounding pharmacies are “mom and pop” pharmacies and lack the sophistication of larger 503B outsourcing facilities. This is not true, especially at Town & Country Compounding. Our pharmacy has multiple high-tech, state-of-the-art sterile compounding laboratories designed to maintain the highest levels of sterility and environmental controls. Our compounding labs have advanced technology and follow strict protocols to ensure a clean and controlled environment. Our team is gowned from head to toe in sterile attire to prevent contamination, underscoring our commitment to safety.
Town & Country Compounding utilizes the same high-quality sources for GLP-1 and other medications as 503B outsourcing facilities and we often buy from the same exact source as the pharma companies. Our team of experts operates in high-tech sterile laboratories, where we compound medications with the utmost care. To guarantee the quality of our compounded injections, we send our products to third-party laboratories for rigorous testing of potency, sterility, and endotoxin levels.
Rigorous testing for compounded medications at Town & Country Compounding (503A)
Quality control is non-negotiable at Town & Country Compounding. Our compounded medications are subjected to stringent testing protocols to verify their purity, potency, and sterility. We source our raw materials from reputable FDA-registered suppliers, ensuring that they meet the required standards. We take the necessary steps to test our compounded products rigorously before they reach patients, thereby ensuring consistent quality.
*Each batch of compounded tirzepatide injections is tested for sterility, potency, and endotoxins. You can request to see our test results.
Professionalism and personalized care with Town & Country Compounding, a 503A pharmacy
One of the key advantages of using a 503A pharmacy is the personalized care we provide DIRECTLY TO THE PATIENTS.
Unlike 503B outsourcing facilities, which primarily supply to hospitals, medical clinics, and telemedicine practices, our pharmacy interacts directly with patients and their healthcare providers. This means we can tailor medications to meet individual needs, whether that’s adjusting dosages or creating formulations for specific patient populations. Our focus on personal relationships allows us to effectively understand and address unique health challenges.
Pharmacists in 503A compounding pharmacies are more directly involved with helping the patient.
Navigating State Licensing Challenges: 503A’s and 503B's are in the same boat
Every pharmacy must apply for a license in each state where they intend to operate. In the past, obtaining multiple out-of-state licenses was a relatively straightforward process. However, recent changes have led to increased backlogs at state boards, meaning it can now take a year or more to secure these licenses in some states.
Many pharmacies are licensed only in the state where they are located, which limits their ability to serve patients across state lines. At Town & Country Compounding, we are currently licensed to ship to almost half of the states, and we are actively awaiting approvals from various state boards. Having a 503A pharmacy as a backup option is essential for patient care, as not many pharmacies are licensed to operate in all states.
Limitations of 503B outsourcing facilities
Restricted Customization: 503B facilities primarily manufacture large batches of standardized drugs, making it challenging to meet individual patient needs or specific dosages.T 503B pharmacies are not involved with an individual patient relationship, but rather a relationship with a facility. 503A pharmacies and pharmacists are directly involved with helping a specific patient.
Limited Access to Certain Ingredients: Due to regulatory restrictions, 503B facilities often cannot access certain active ingredients that compounding pharmacies can source, limiting their options for patient-specific formulations.
Lengthy Production Times: Batch production processes and regulatory requirements may lead to longer production times, which can delay access to medications in urgent cases.
Focus on Sterile Compounding Only: 503B outsourcing facilities often focus on sterile products, meaning their range of non-sterile preparations may be limited or unavailable.
Why Choose Town & Country Compounding?
In an era of increasing medication shortages, the reliability of 503A compounding pharmacies is more critical than ever. At Town & Country Compounding, we are dedicated to providing high-quality, customized medications while maintaining strict adherence to safety and efficacy standards. Our team of expert pharmacists is here to ensure that every patient receives the attention and care they deserve.
Choosing Town & Country Compounding means choosing a partner in health that values quality, safety, and personalization. We invite you to experience the difference that a dedicated 503A pharmacy can make in your healthcare journey. Together, we can ensure that you receive the medications you need, precisely tailored to your individual needs.
For more information or to speak with one of our pharmacists, contact us today. Let us show you how we can make a positive impact on your health and wellness!
