Specialized compounding for clinical trial medications and research

Clinical Trial Medications and Specialized Preparations

Boulevard Pharmaceutical Compounding Center has experience in the preparation of medications for clinical trials and specialized preparations. We will facilitate the processing of quantities desired in blinded or open-label formats of the study medication. We are able to achieve this in various forms, including capsules, sterile injections, sterile preservative-free eye drops, nasal sprays, transdermal creams and gels, topical sprays, suppositories, and sublingual drops. If you need additional variables in drug delivery, our team will work with you to address the challenges you face in these critical research study situations. We custom compound medication forms with active or placebo dosage forms.

We can provide these medications in inpatient trial kits with patient information or other required documentation. For blinded trial medications, both the study medication and placebo will be appropriately labeled for the study coordinator's key reference.


All formulas and samples must be designated “For Investigational Use Only”.
The master formula should include:

  • Product name or number (NIH)
  • Study identification name or number
  • Dosage strength
  • Dosage form
  • Ingredient name and quantity
  • Total theoretical weight if applied
  • Approval date and signature

Compounding record (all that is in the master formula record):

  • Compounding instructions
  • Ingredients
  • Weight
  • Manufacturer
  • Lot numbers
  • Expiration dates
  • Order of addition
  • Equipment used
  • Temperature is important
  • Mixing speeds and times
  • Storage conditions
  • Test results if needed
  • Certificate of analysis on all ingredients
  • MSDA if applicable
  • Calibration test on equipment

Notes: Precautions, safety issues, measures taken in adverse events.
Packaging: Blister pack dosage cards of 30 or 60 capsules with weeks/months dosages pre-loaded may be added to the study.

Pricing: Based on individual study and dependent on Pharmacists' hours and certified techs' hours needed to complete the study.

Still have questions or concerns? Contact our pharmacist today for more information.

For more questions and other concerns, you may reach out to us here.