The Rockefeller University Hospital Research Pharmacy space is being upgraded in order to keep pace with Investigators’ needs and stay ahead of the rapidly changing regulatory environment.
The Pharmacy currently serves the Hospital inpatient unit and Heilbrunn Outpatient Research Center by preparing and providing all pharmaceutical products (i.e., both investigational and FDA approved). The Pharmacy also provides drug formulation services and drug development guidance to Rockefeller investigators seeking to transition their discoveries from the laboratory to the clinic.
The existing Pharmacy space was built at a time when Rockefeller investigators and employees required the pharmacy to prepare topical products (cream, ointments, coal tar preparation), dispense investigational controlled/limited distribution substances (methadone, 100% ethyl alcohol), and provide a retail dispensing service for employees. To provide those services the design included a very large safe and floor-to-ceiling shelves and drawers, which are accessible only by ladder, for the many mortars, pestles, bottles, Bunsen burners, funnels, and ointment slabs; it even had space for the coal tar barrel!
Investigators now require a different set of services involving drug dispensing, drug information services, and inventory management. In addition, many investigational products are biologics that require special storage conditions, and are commonly administered by injection or infusion. So the tools of the trade are now computers, printers, labels, paper, databases, refrigerators, freezers, and most importantly, cleanroom technology.
The renovation will include a state-of-the-art cleanroom for preparation of sterile products. New York State and federal regulations governing sterile product preparation have changed significantly since the 1990s, starting with Congress passing the FDA Modernization Act of 1997. Pharmacies that prepare sterile products must now meet the stringent requirements of the Federal Food, Drug, and Cosmetic Act, Section 503A. As an indication of the pace of regulatory change in the past 10 months a number of new FDA guidance documents have been issued on this topic (page 8).
The standards and procedures to be followed when compounding sterile products, recognized by FDA and State Pharmacy Boards, are developed and issued by the United States Pharmacopeia (USP), and are commonly referred to as “USP<797>”. The active USP chapter <797>, which issued in 2008, has been undergoing revision since 2010, and currently has a number of revisions pending that likely will become effective over the next two years. Those revisions are provided in table 2 (page 8). The New York State Board of Pharmacy issued rules for Compounded Sterile Products in 2010. The renovations planned for the Hospital pharmacy will incorporate features that anticipate adoption of these currently drafted standards, which are likely to come into effect over the next 2 years. Of the many requirements set forth in these guidance documents and standards, a number are of particular interest to clinical investigators who are formulating new products for early phase studies. These are summarized in Table 3. Although such products are guided by IND Chemistry Manufacturing and Controls (CMC) regulations and related guidances and standards, they share some characteristics with compounded medications. For example, they are prepared in small batches (lots), and whenever possible simple formulations are prepared since the primary objective is to demonstrate proof of principle, and thus higher level formulation-related attributes such as ease and convenience in administration are of a lesser importance.
During the renovation of the current pharmacy space, the pharmacy will move into a temporary home on the second floor of the Hospital building. Once the renovations of the original space are complete, the pharmacy will move back into its original space on the first floor of the Hospital building. During the entire renovation period, all services will be provided in an uninterrupted manner.