Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

PhRMA, representing leading biopharmaceutical research companies, opposes the Outsourcing Facilities Association's (OFA) nomination of bulk drug substances for the 503B Bulks List. They argue that the OFA's "en bloc" nomination lacks specific evidence of clinical need, poses significant patient safety risks, and undermines the integrity of the FDA's drug approval process.

Long Grove Pharmaceuticals, LLC, opposes the inclusion of norepinephrine bitartrate on the 503B bulks list, arguing that the drug is "essentially a copy" of their already FDA-approved product. They contend there is no clinical need for compounding from bulk drug substances and express concerns regarding the quality and safety of products from outsourcing facilities.

Zyla Life Sciences opposes the nomination of bulk indomethacin to the FDA's 503B Bulks List, arguing that there is no clinical need for compounding it. The company contends that existing FDA-approved products can meet patient needs and highlights safety concerns regarding the manufacturing process of compounded suppositories.

Eton Pharmaceuticals, Inc. opposes the inclusion of phenylephrine hydrochloride in the 503B Bulks List for use in compounding injectable drug products at concentrations of 0.1 mg/mL or below. The company argues that because they have an FDA-approved product (BIORPHEN®) for this indication, there is no clinical need for compounded versions and that such compounding undermines the new drug approval process.

Merz North America, the authorized U.S. distributor of Asclera® (polidocanol) injection, opposes the inclusion of polidocanol on the 503B Bulk Drug Substance List. They argue that there is no demonstrated clinical need for compounded polidocanol and that compounding the substance from bulk drug material poses significant safety risks, including microbial contamination and inconsistent potency.

MedDay Pharmaceuticals opposes the inclusion of high-dose biotin (greater than 60 mcg) on the 503B Bulks List. They argue that there is no demonstrated clinical need for compounding high-dose biotin and that it presents unique safety risks and impurities compared to lower dosages.

Arnall Golden Gregory LLP, representing a client, argues that intrathecal baclofen is not appropriate for bulk compounding due to significant safety risks, lack of unmet clinical need, and the availability of FDA-approved commercial products. They request that the FDA remove the substance from the interim list of substances under evaluation and formally determine it is not appropriate for the Bulk Substances List.

TerSera Therapeutics LLC, the holder of the NDA for Prialt (ziconotide), opposes the nomination of ziconotide to the 503B Bulk Drug Substance List. They argue that the proposed compounded products pose significant safety risks, lack a demonstrated clinical need, and do not offer any advantages over the existing FDA-approved formulation.

Avedro, Inc., a pharmaceutical and medical device company, opposes the inclusion of Ophthalmic Riboflavin on the FDA's 503B Bulks List. They argue that there is no clinical need for compounded riboflavin because Avedro's own products are the only FDA-approved solutions for treating progressive keratoconus and that the nomination lacks adequate supporting data.

Latham & Watkins LLP, representing their client Par Sterile Products, LLC, opposes the nomination of vasopressin to the FDA's list of bulk drug substances for compounding. They argue that there is no clinical need for a compounded version of the drug, that it poses significant safety risks, and that it would essentially be a copy of an already FDA-approved product (Vasostrict®).