February 5, 2016
Stephen Ostroff, M.D.
Acting Commissioner
Food and Drug Administration
Room 5266, White Oak Office Building 51
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Ostroff:
ASHP is grateful for the extension of enforcement discretion granted by the Food and Drug Administration (FDA) to dispensers until March 1, 2016, under Title II of the Drug Quality and Security Act. ASHP members are committed to ensuring that our supply chain for pharmaceutical products remains the safest in the world, and that medications administered in hospitals and health systems are of the highest quality. In preparation for the upcoming end date of the enforcement discretion, ASHP would like to meet with you to discuss remaining unanswered compliance questions with respect to the Drug Quality and Security Act (DQSA) and to ensure our interpretations of the dispenser requirements under the law are accurate.
Title II of the DQSA lays out a framework for the tracking of certain prescription drug data through the supply chain, from manufacturer to end user, or dispenser. The law requires that dispensers collect and store for up to six years transaction information, transaction history, and a transaction statement for prescription drugs not exempt under the law. As we indicated in a June 2015 letter, our members have questions about the exemptions from passing the transaction information, transaction statement, and transaction history (3T), with respect to certain products.
For example, hospitals and health systems frequently need to transfer drugs from one dispenser to another to serve a patient-specific need, a transfer that ASHP understands is exempt from the requirement to provide the 3T information. ASHP believes that, in order to fulfill this important function, a dispenser needs to have the ability to charge the receiving dispenser for this provision of patient-specific medications in order to accommodate for the cost of the drug. ASHP believes this does not require the dispenser to comply with any wholesaler requirements in the DSCA (assuming the volume of transactions does not exceed any state regulatory volume restrictions). ASHP would like to confirm this interpretation with the FDA.
ASHP has produced frequently asked questions (FAQs) for our members to support their implementation and compliance with the DQSA. One of these FAQs addresses the supply of medications to first responders. We would like to continue this discussion with the FDA. We realize there are various ambulance service arrangements in the United States, and we would like to ensure that the need to supply first responders is not inadvertently mixed in with other non-emergent ambulance providers. This would include the need to supply first responders with naloxone in the states and jurisdictions where it is being approved.
Further, ASHP would like to bring to the attention of FDA several areas where we believe additional guidance is needed. Those areas in question are investigational drug services (IDS), state-run vaccine programs, local- and state-managed disaster medication programs (i.e., atropine and 2-PAM autoinjectors), exemptions of certain intravenous fluids, and the FDA’s expectations and/or communications with state boards of pharmacy regarding their plans for enforcement of the DQSA. ASHP would also like to request that FDA consider a follow-up meeting or workshop, aimed specifically at IDS experts and related stakeholders, to study the various models on how study drugs and the adjunct medications, both in human and animal research studies, should be handled. Again, ASHP believes that additional guidance may be needed in this area. Finally, ASHP would like to obtain clarification from FDA that state vaccine and disaster medication programs are not covered transactions within DQSA but rather are exempt from the requirements of the act.
Our members have also brought to our attention questions about whether certain other drugs are covered under the DQSA. The products in question include blood products and blood components (i.e., IVIG, albumin, RhoGAM) and prescription devices such as prefilled syringes, skin adhesives, and glues. Our members have asked whether these products are exempt from the DQSA given their unique composition.
For the reasons outlined above, ASHP is requesting an opportunity to discuss remaining questions our members have with respect to DQSA compliance. If we cannot obtain answers to these questions soon, we believe that FDA will need to once again consider extending the compliance deadline.
Sincerely,
Kasey K. Thompson, Pharm.D., M.S., M.B.A.
Senior Vice President and Interim Chief Operating Officer
Office of Policy, Planning and Communications
Cc: Ilisa B.G. Bernstein, Pharm.D., J.D., Deputy Director, Program Operations, Office of Compliance
Connie T. Jung, RPh, PhD, Associate Director for Policy and Communication, Office of Compliance