Compounding Specialists

Our 503A compounding facility, laboratory and clean room environments are outfitted with advanced technology, enabling us to meet ever-increasing demand for personalized medications. 

Discover the safety, quality and excellence behind our premium compounded formulas that CRE8 Compounding Pharmacy can provide for your patients. Fully customized products according to any specific need – start with us today!

Regulatory Compliance

USP
CRE8 Pharmacy is compliant with USP chapters <795> and <797> for non-sterile and sterile compounding practices. We comply with new USP <800> guidelines for the handling of Hazardous Drugs (HD’s).

DRUG QUALITY AND SECURITY ACT
Signed into law in November 2013, the DQSA is an important step forward in improving the safety of the national drug supply. We adhere to the guidance provided under section 503A of the Food, Drug, and Cosmetics Act (FDCA). Compounded medications must comply with the following:

  • Chemicals used have USP/NF monographs
  • Chemicals are approved for human use
  • Chemicals must be on an approved list
  • Medications must be compounded for a patient-specific prescription

STATE LICENSES
CRE8 Pharmacy holds non-resident licenses throughout the U.S. Please contact us with any inquiries.

Quality Assurance

API PURITY & BULK INGREDIENT SAFETY
“Lives depend on a job well done”
The Professional Compounding Centers of America (PCCA) is the industry leader in API (Active Pharmaceutical Ingredient) quality and purity. This premium ingredient quality is what separates our finished compounded medications from the competition. Learn more about API quality:
http://www.pccarx.ca/about-pcca/pcca-quality

In order to ensure supply chain integrity, all active chemicals, bases, excipients and raw materials must comply with the following quality standards:
• USP/NF monograph
• Obtained from FDA approved manufacturers and wholesalers
• Certificates of Analysis for all active pharmaceutical ingredients
• Chemicals sourced from reputable distributors with 100% traceability (pedigree)

FINAL PRODUCT SAFETY & TESTING
Components and finished preparations undergoing end-preparation testing remain in quarantine until third party test results are obtained and reviewed by a Pharmacist prior to release. Testing includes pH, particulate, endotoxin, sterility, potency and method suitability. Labeling is compliant to reflect all ingredients and appropriate Beyond Use Dates (BUD’s).

*All testing is performed by an independent FDA registered laboratory.

REGULAR SITE INSPECTIONS
We are inspected by the Florida State Board of Pharmacy, DEA, FDA and the Verified Pharmacy Program (VPP) under the National Association of Boards of Pharmacy (NABP).

CONTINUING EDUCATION
Qualified technicians, pharmacists and support staff are required to successfully complete ongoing courses and examinations throughout the year. These include procedure evaluations, employee training and validation along with regular SOP adherence verifications.

CUSTOMER SERVICE
We put every effort in creating a client experience that is clear, prompt and solution oriented. The following resourcesare available to you:

• Dedicated Practitioner Liaison
• On-site customer support staff
• Pharmacist available for consult

Laboratory Environment

OUTFITTED WITH cGMP COMPLIANT EQUIPMENT & ISO CLASS CLEANROOMS

• Biological Safety Cabinets: LabcultureClass II, Type A2 for all compounding.
• ISO 5 positive pressure non-HD cleanroom for sterile compounding
• ISO 7 negative pressure HD cleanroom equipped with a vented Bio Safety Cabinet Labculture Class II, Type A2 for sterile hazardous drug compounding.
• State-of-the-art lyophilizer providing quality freeze-dried powders for reconstitution
• Jetstream Air shower using ULPAfiltered air jets
• Hydrogen Peroxide fogger for decontamination and disinfection of clean rooms to ensure sterility after each use.

ENVIRONMENTAL MONITORING & BACKUP SYSTEMS
• All controlled environments are equipped with High Efficiency Particulate Air (HEPA) filters.
• 24/7 real-time monitoring for temperature, air pressure and humidity
• Semi-annual certifications of biological safety cabinets and clean rooms
• Dedicated Secure Server (HIPAA)
• Automated generator backup

PHARMACY SOFTWARE – PioneerRx
• Barcode tracking for start-to-end traceability
• Compatible with e-prescribing portals such as SureScripts, LifeFile etc.

STANDARD OPERATING PROCEDURES (SOP’s)
We adhere to all SOP requirements as outlined in USP <795> <797> and <800> chapters. CRE8 Pharmacy utilizes a formal QA program which encompasses all aspects of preparation and testing. This ensures compliance by all pharmacy personnel in training, handling of raw materials and completed compounds, and requirements for all controlled environments.

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