INVESTIGATIONAL DRUG PRODUCTS: REGULATORY CHANGES THAT MAY HAVE IMPLICATIONS FOR YOUR CLINICAL TRIAL CONDUCT SITES — Hancock Daniel
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INVESTIGATIONAL DRUG PRODUCTS: REGULATORY CHANGES THAT MAY HAVE IMPLICATIONS FOR YOUR CLINICAL TRIAL CONDUCT SITES

Navigating compliance requirements in a space co-regulated at both the federal and state level can be complex and challenging. Recent changes in how the Virginia Board of Pharmacy classifies investigational drug products (IDPs) provides an excellent example of the types of challenges posed by co-regulation.  For providers, hospitals and health systems engaged in clinical research activity, keeping abreast of such changes can be as tricky as implementing the required changes themselves.

IDPs are regulated by a myriad of federal and state authorities including the Drug Enforcement Agency (DEA), the US Food and Drug Administration (FDA) and individual state boards of pharmacy. The DEA makes its classification determinations as to whether a product is “controlled” or “scheduled” based upon the active pharmaceutical ingredients (API) (and not upon a product’s designation as an IDP alone). Therefore, for example, a Virginia pharmacy must consider on a drug-by-drug basis whether registration with the DEA is required to dispense the study IDPs. Recent changes in IDP classification in Virginia, however, now eliminate those drug-by-drug registration considerations at the state level.

Quite recently, all IDPs have been drawn under the definition of “schedule VI” drug products by the Virginian Board of Pharmacy (Code of Virginia § 54.1-3455). This bright line classification was made, notwithstanding an IDP having already been FDA approved for other indications, based upon the fact that the IDP “method of use” in trial is not generally recognized among experts qualified by scientific training and experience to evaluate their safety and efficacy as safe for use except by or under the supervision of a practitioner licensed to prescribe or administer such drug. For many clinical investigational sites in Virginia, this change requires an adjustment in how IDPs are dispensed to study participants. Where hospitals are involved in clinical trial conduct, they may want to reconsider having IDPs dispensed directly out of the hospital pharmacy instead of from the hospital research department drug service or from physician investigator offices. If a hospital elects to continue with former practices, the dispensing pharmacist must be covered under the hospital’s license and the department location must be registered as a satellite pharmacy. Accordingly, the pharmacist-in-charge (PIC) of that discreet location would be required to follow all applicable Board of Pharmacy regulatory requirements including providing notice to the Board under 18 VAC 110-20-140 and ensuring compliance with subsections B through G of 18 VAC 110-20-150, 18 VAC 110-20-160, subdivisions 5 and 6 of 18 VAC 110-20-170, 18 VAC 110-20-180 through 18 VAC 110-20-190. Alternatively, where IDPs are dispensed out of a physician’s office or at that satellite location by a physician investigator, that individual would be required to obtain a controlled substance registration (CSR) under Code of Virginia § 54.1-3422 and adhere to strict procedural constraints including (but not limited to):

  • Inspection of the facility by the Board prior to the CSR being issued.
  • Dispensing limited to the physician’s own patients only.
  • Maintenance of dispensing records.
  • Inventory requirements for DEA scheduled drugs (where applicable).
  • Prohibitions against nurse practitioners and physician assistants dispensing IDPs.

If you have any questions about these co-regulatory complexities or to learn more about whether your state-specific IDP requirements have changed, please contact a member of Hancock Daniel’s Life Sciences team.

The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel  & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.