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ASHP Comments on FDA Proposed Exclusions from 503B Bulks List

Food and Drug Administration

October 29, 2018

[Submitted electronically via]
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

RE: Docket No. FDA-2018-N-3240 — List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

ASHP is pleased to submit comments to the U.S. Food and Drug Administration (FDA) on the proposed exclusion of bumetanide, nicardipine hydrochloride, and vasopressin from the 503B bulks list. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s 45,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.

ASHP advocates for a strong compounding framework. We believe that a robust 503B outsourcing facility program is essential to realizing the goals of the Drug Quality and Security Act (DQSA). For many of our members, 503Bs are a vital link in their compounding supply chain. ASHP appreciates FDA’s efforts to clarify the types of products 503B outsourcing facilities can permissibly compound under 503B.

To provide FDA with useful input, ASHP asked members about the need for bumetanide, nicardipine hydrochloride, and vasopressin products compounded from bulk by 503B outsourcing facilities. Member responses indicate that there is a need for bulk compounding of these products. In particular, if tablets are the only formulation available and an oral solution is required for a patient (this is particularly likely for pediatric patients), starting with bulk product yields better results than crushing tablets and does not require having to control for excipients.

Regarding the issue of “clinical need” for 503B products compounded from bulk generally, ASHP would like to take this opportunity to reiterate our previous request that FDA broaden its definition of clinical need. In the March 2018 guidance regarding evaluation of substances for the 503B bulks list, FDA notes that “supply issues, such as backorders” are not considered clinical need. ASHP remains concerned that a narrow focus on the FDA Shortage List will not adequately address the potential impact of shortages on care. Specifically, in cases where patients cannot obtain a drug, and it does not appear on the FDA Shortage List, we encourage the agency to consider other sources of shortage information, including the ASHP Drug Shortages List. Because FDA’s shortage determinations are based on national drug production and utilization data, they do not always accurately reflect real-time, point-of-care shortage status. In particular, the FDA Shortage List may not reflect low allocation of shortage drugs by distributors to entities with limited buying power, contractual obligations prohibiting or strictly limiting off-contract purchasing or selling, limited distribution systems, and/or geographic areas with only one distributor or wholesaler. Thus, a comprehensive picture of shortages requires the use of multiple lists. If the FDA’s intent is that 503Bs should help address all shortages, the additional information offered by other sources such as the ASHP Drug Shortages List will be essential to mitigating shortages throughout the country.

ASHP appreciates the opportunity to provide FDA with feedback on the 503B bulks list. We look forward to continuing to work with FDA to develop a workable and effective compounding regulatory framework, including a comprehensive 503B bulks list. Please contact me at [email protected] or (301)-664-8698 if you have any questions or wish to discuss our comments further.


Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs