As we begin 2022, the teams at VLS Pharmacy and New Drug Loft are excited for the fresh start of a new year. We have a renewed focus on our promise to you, our prescribers. With this thought in mind, let’s take a closer look at the differences between 503A and 503B compounding pharmacies. We’ll also consider how VLS Pharmacy and New Drug Loft will maintain our strong commitment to you and your patients in the coming year.
We are proud to share that our dedication to excellence is being recognized by third parties. Most recently, our compounding-pharmacist-in-charge and owner Gopesh Patel was chosen as America’s Pharmacist for December 2021 by the National Community Pharmacists Association (NCPA). As the NCPA states, “For Gopesh Patel, helping patients feel better is the greatest reward.” Our staff members are honored to work alongside him. Congratulations, Gopesh!
503A vs. 503B Compounding Pharmacy
To start, let’s note the distinction between 503A and 503B compounding pharmacies. Regardless of the type of pharmacy, it’s important to work with an established, certified, and quality-assured facility to ensure patient safety.
A 503A compounding pharmacy is known as a traditional, patient-focused compounding facility.
503As fulfill individual, patient-specific prescriptions that are written and approved by licensed medical professionals. The pharmacies are led by a licensed pharmacist who has completed additional training in compounding in a licensed facility.
503A compounding pharmacies comply with state boards of pharmacy regulations. They produce compounds in compliance with United States Pharmacopeia (USP) chapters or the National Formulary (NF) monograph in order to ensure patient safety and maintain drug quality and purity. Additionally, every active pharmaceutical ingredient (API) used for the compounding process must be made at a facility registered by the Food and Drug Administration (FDA) and be accompanied by a valid Certificate of Analysis (COA). Lastly, 503A compounding pharmacies cannot compound drugs that have been removed from the market or have been proven unsafe or ineffective by the FDA.
A 503B compounding pharmacy is designated as an outsourcing facility.
A 503B compounding pharmacy produces large batches of compounded drugs with or without prescriptions to be sold to healthcare facilities for in-office use only.
The Benefits of Being a 503A Compounding Pharmacy
VLS Pharmacy is a 503A compounding pharmacy. But how does this designation affect you? As a prescriber, you enjoy the following benefits:
- We take a patient-first individualized approach. By working closely with our prescribers to design a customized medication, we take into account the patient’s allergies, comorbidities, and concurrent drugs. Plus, we personally reach out to every patient to educate them on the usage and side effects of each compound.
- We never compromise on quality. Additionally, we follow stringent quality control measures when it comes to garbing and gowning. We also apply the same International Organization for Standardization (ISO) guidelines for equipment.
- We strive to deliver value through our longstanding relationships. To do so, we don’t produce large quantities of medications in advance and only compound based on patient needs. Furthermore, because we have been serving our communities for over three decades, we are able to pass along savings from our established wholesalers directly to patients.
Our Attention to Detail Allows You to Focus on Patient Care
Now that we’ve established the meaning and benefits of being a 503A compounding pharmacy, let’s take a closer look at what sets us apart from our competitors.
First and foremost, VLS Pharmacy and New Drug Loft apply meticulous measures to guarantee the safety, stability, purity, sterility (where applicable), and quality of each formulation. From preparation to administration, all compounded formulas are created with high quality, pharmaceutical-grade APIs sourced directly from PCCA, the leader of superior APIs thanks to their high standards and lot testing against the COA, USP, NF, EP, FCC, and ACS. Moreover, VLS Pharmacy meets USP <797> sterile compounding standards and USP <795> non-sterile guidelines. Plus, we are home to one of the first labs built to the USP <800> chapter for handling hazardous drugs.
Next, our formulas undergo third-party potency and stability testing. We also enforce high-sensitivity rapid endotoxin detection in-house, which allows for quicker delivery times to patients without undermining our results. Additionally, we guarantee an extra level of preformulation testing because we receive APIs directly from PCCA. There, all ingredients complete 14 high-level checks and reviews in order to pass inspection.
Our Diverse Selection of Compounding Solutions and Personalized Customer Experience
Given the broad needs of our prescribers and your patients, we offer both sterile and non-sterile compounding solutions. Our preparations range from transdermal gels and oral capsules to intramuscular injections, ophthalmic preparations, and more.
Additionally, we are proud to offer the most diverse array of custom formulation options in an effort to meet any medical or lifestyle requirement. A one-size-fits-all approach is not the best answer given possible therapeutic needs. Whether it’s nutritional intravenous therapy to combat vitamin deficiencies, bioidentical hormone replacement (BHRT) for aging patients, or a topical treatment to address dermatological needs, VLS Pharmacy and New Drug Loft delivers medications specialized to each specific patient.
Finally, our customer experience — from placing an order to collaborating on a formula or refill — is personalized and seamless. Our team is always available to offer our prescribers and your patients expert advice and support.
Maintaining Outstanding Standards of Quality and Control for 2022
Despite the current challenges facing the pharmaceutical industry, like global supply chain delays and high demand, we are committed to maintaining our outstanding standards of quality and control for 2022. In order to do so, we have incurred significant cost increases.
In response to this inflation, VLS Pharmacy and New Drug Loft will be implementing price increases, as needed and effective immediately. As always, our priority is to provide you and your patients with premium science, service, and compounded solutions, and we remain dedicated to this pledge during these unprecedented times.
In an effort to offset delayed shipping in the coming months, we encourage you to:
- Start thinking about what you need and make a quarterly plan.
- Order early to avoid “ASAP timelines.” Quick turn-arounds aren’t currently possible unless you are prescribing a life-saving medication.
- Write and submit prescriptions early. If possible, 90-day supplies are best.
VLS Pharmacy and New Drug Loft
As a 503A compounding pharmacy specializing in sterile and non-sterile compounding, we will support you and your patients by creating safe, individualized, and effective pharmaceutical therapies. For men and women at any age, feeling healthy, conﬁdent, and comfortable is of the utmost importance. Therapeutic needs may change with each life stage. As such, they require an adaptive and personalized treatment plan. By working with a trusted compounding pharmacy like VLS Pharmacy and New Drug Loft, you are expanding the possibilities for successful and sustainable care for your patients.
Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients.
All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
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