Catalent currently manufactures approved prescription drugs under contract agreements serving as a Contract Manufacturing Organization (CMO) to our customers (Application Holder) who hold approved applications (NDA/ANDA/BLA) with the Food and Drug Administration (FDA).

As a CMO of approved prescription drugs, Catalent's business operations include manufacturing, labeling, packaging, and analytical testing activities.

Catalent’s customers (Application Holder) or their co-licensed partners set pricing for the prescription drug products they distribute and or market; Catalent as a CMO does not participate in distribution/marketing nor price-setting thereof. 

The VA Emergency Regulation 12VAC5-219. Prescription Drug Price Transparency Regulation (adding 12VAC5-219-10 through 12VAC5-219-140) requires manufacturers to register with the NDSO [12VAC5-219-20. Registration] and provide information [12VAC5-219-70. Manufacturer reporting requirements] that only an approved Application Holder or their co-licensed partners would have readily available.

Likewise, the VA Code at § 32.1-23.4. (Effective January 1, 2022) Prescription drug price transparency; civil penalty and § 54.1-3442.02. (Effective January 1, 2022) Prescription drug price transparency requires manufacturers to report information that only an approved Application Holder or their co-licensed partners would have readily available. The definition of “manufacturer” in this regulation is the same as defined in § 54.1-3401 and means “every person who manufactures, a manufacturer's co-licensed partner, or a repackager,” and “manufactures” means “the production, preparation, propagation, conversion, or processing of any item regulated by this chapter, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container.”

Therefore, we recommend that the regulation explicitly exclude CMOs [and similar organizations] who manufacture but do not participate in marketing or price-setting activities from registering and reporting under VA Emergency Regulation 12VAC5-219.  Instead, we recommend the regulation explicitly adopt the Drug Supply Chain Security Act (DSCSA) definition for Manufacturer which refers to an approved Application Holder or their Co-Licensed Partner (as both terms are defined therein). The approved Application Holder or their Co-Licensed Partner who markets a prescription drug product that is subject to reporting under this regulation and/or who sets pricing for such prescription drug are the appropriate entities to register and report under the VA Emergency Regulation 12VAC5-219 and VA Code at § 32.1-23.4 and § 54.1-3442.02.