What is the legal basis for compounded medications in the United States?
When a drug is in shortage, compounders can prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. Click here to see the list of drugs currently on the FDA drug shortage list.
Former Ro.co's Chief Medical Officer Dr. Tzvi Doron provides a GLP-1 agonist update to CareValidate's 50-state provider network. Skip to the 40 minute mark in the video for the segment on compounded GLP1's.
What is the CareGLP Compounding Pharmacy Network?
CareValidate Inc. operates a nationwide network of over fifty 503a and 503b compounding pharmacies. Powered by the SOC2, HIPAA, GDPR and CCPA, Third Party Certified CareGLP API and Platform compounded medications are safely dispensed and shipped to patients.
What is the difference between a 503a and 503b compounding pharmacy?
The FDA has designated 503A compounding pharmacies as those that compound according to prescriptions specific to particular patients and are required by state boards of pharmacy to comply with USP and other guidelines.The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only. Unlike a 503A facility, 503B compounding pharmacies must validate every process according to CGMP. 503A pharmacies must comply with USP <795> and <797> along with state board of pharmacy regulations and perform Environmental Monitoring every six months. Beyond Use Dating (BUD) may be assigned based on internal or external scientific literature showing stability. 503B pharmacies must comply with USP <795> and <797> along with state board of pharmacy regulations and 21 CFR Part 210 and 211 (CGMP), among several other regulations and guidelines.
What is CareValidate's Compliance Check protocol for compounding pharmacies that want to join the CareGLP Compounding Pharmacy Network.
CareValidates compliance team consists of physicians, pharmacists and legal experts. For every application their review consists of, but is not limited to:
Pharmacy Public Address
Duration in Business
Number of Entity Names
State Pharmacy Board Citations
Credential Information with Supervision
List of Current Employees
CDS Schedules and Restrictions
Pharmacist Licensure
Prior Board Orders to Pharmacist (s)
Certificate of Analysis for API's
Stability Studies used for establishing beyond-use dating (BUD)
FDA or DEA Inspection Reports
Independent Lab Reports
Adverse Drug Event Reporting Procedure
Drug Recall Procedures
FDA Registration (503b)
Site Visit (503b)
How does the patient experience differ between compounded vs. branded medications?
To promote patient access and choice, the pharmacies in the CareGLP network offer both compounded and branded medications. The comparison table below shows the major differences between the two choices.
| Patient experience | Compounded | Branded |
|---|---|---|
| Regular consultations with a licensed medical provider | ☑️ | ☑️ |
| Anytime messaging to ask questions or report side effects | ☑️ | ☑️ |
| Educational resources | ☑️ | ☑️ |
| Cash pay option | ☑️ | ☑️ |
| Medication delivered directly to patient's home | ☑️ | Picked up at preferred pharmacy or mail order |
| Insurance coverage option | ⓧ | Dependent on plan inclusion and prior authorization |
| Doses taken via prefilled injection pens (auto injectors) | ⓧ | ☑️ |
| Doses taken via multi-dose vial and sterile syringes | ☑️ | ⓧ |
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