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You are a healthcare provider dedicated to delivering the best possible care to your patients, and we are here to help you.
We understand the importance of personalized treatment plans tailored to each individual's unique needs. Specializing in sterile and non-sterile compounding, our pharmacy creates customized medication solutions across a wide range of specialties, from women’s and men's health to hormone therapy, anti-aging treatments, weight management, dermatology, and beyond.
Our Commitment to Quality
We prioritize safety and quality in every medication we compound. Our commitment to excellence allows us to offer your patients medications that provide them with personalized paths to better health and improved outcomes. Here’s how we ensure that each medication meets the highest standards of safety and efficacy:
- Potency, sterility, and endotoxin testing to ensure each medication is safe and reliable.
- Adhering to USP 795, 797, and 800 standards ensures that our medications meet the highest quality and safety requirements.
- Our sterile and non-sterile labs undergo testing and certification by a third-party company.
Dosage Forms
Pure Pharmacy offers a diverse range of dosage forms and delivery methods tailored to meet your patient's needs. We ensure convenient administration and absorption by offering a variety of topical preparations, oral medications in various forms, suppositories, nasal sprays, and injectables. We are committed to providing comprehensive solutions for individual patient requirements.
FAQs
Here are some frequently asked questions about Pure Pharmacy's quality assurance measures and standards.
Quality assurance is our top priority at Pure Pharmacy. Our designated team of quality specialists oversees every aspect of pharmacy operations, including certification, sourcing, quality control, facilities, production, safety, training, and testing in order to ensure we meet the expectations of patients, providers, and industry regulators, alike.
As a licensed 503A compounding pharmacy, we are compliant with USP Chapters <795>, <797>, and <800>. These guidelines set the national standards for non-sterile compounding, sterile compounding, and hazardous drug compounding, respectively. All aspects of our compounding operations – including ingredient sourcing, safety, training, production, and product testing – meet or exceed the requirements of these guidelines.
We invest in the ongoing internal and external training and competency evaluation of all sterile and non-sterile compounding personnel. By ensuring that our team members are equipped with the latest knowledge and skills, we maintain a culture of excellence and continuous improvement.
New employees undergo a structured training process, starting with shadowing experienced staff, progressing to hands-on training with a trainer, followed by supervisor observation before they are deemed capable of working independently. Additionally, all compounding technicians are required to complete ACPE -accredited annual compounding training. External training is also provided, with all sterile compounding technicians attending an offsite ACPE- & PTCB-accredited Sterile Compounding Course within one year of hire, regardless of prior experience or training.
Yes! Our sterile compounding laboratory meets all USP Chapter <797> requirements. This ensures that our compounding processes meet the industry standards of cleanliness and safety, providing peace of mind to both patients and providers. The custom-built, state-of-the-art lab undergoes rigorous testing by third-party NSF and CNBT-accredited certifiers to meet or exceed USP specifications.
Additionally, we employ a vigorous environmental monitoring program in the laboratories to continuously protect the integrity of our products.
At the core of our day-to-day operations is a robust quality control system. All compounds undergo a formula-specific quality control review before they are released from the laboratory for dispensing.
In accordance with USP <797>, a sample of each sterile compound batch is sent to a third-party ISO-17025 accredited laboratory for Sterility Testing (USP <71>) and Endotoxin Testing (USP <85>). Each batch must pass these tests before it is released for dispensing.
The foundation of a quality compound starts with the raw ingredients we use. All active pharmaceutical ingredients (APIs) used at Pure Pharmacy are sourced from FDA-registered facilities. All new APIs are vetted by our quality specialists to make sure they not only meet regulatory requirements, but also our strict patient safety standards.
After approval, all ingredients we receive must be accompanied by a certificate of analysis (COA). The COA proves that it meets the potency testing and specifications of the USP-NF monograph or other applicable standards. Each COA is closely inspected by one of our compounding supervisors before use.
- We conduct several types of internal audits to identify areas for improvement and ensure compliance with quality standards. This includes six-month compounder competency observations, monthly laboratory walkthroughs, and audits of our vendors and third-party laboratories.
- We do not just rely on our internal oversight. Pure Pharmacy proudly maintains several national certifications to demonstrate our commitment to quality and safety:
- Pharmacy Compounding Accreditation Board (PCAB):
- Non-sterile Pharmacy Compounding Accreditation
- Sterile Pharmacy Compounding Accreditation
- Hazardous Drug Handling Accreditation
- National Association of Boards of Pharmacy (NABP)
- Verified Pharmacy Program (VPP) Inspection
- Pharmacy Compounding Accreditation Board (PCAB):
These national non-for-profit organizations hold us to higher standards and perform stringent inspections on a regular basis.
We are compliant with USP Chapters <795>, <797>, and <800>.
Contact Information
For prescription submissions, please access our convenient provider portal. If you have any inquiries or need assistance, feel free to reach out to us at [email protected]. We're here to support you in delivering the best care to your patients.
