Md. Code Regs. 10.34.22.03-1

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.34.22.03-1 - Minimum Application Requirements for Virtual Manufacturers

The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requirements:

A. Provides a list of drug or device products it distributes;

B. Provides a list of the NDA or ANDA numbers associated with each drug it distributes;

C. Provides a list of the UDI numbers, as available, associated with each device it distributes;

D. Provides the name and facility address of the contract manufacturer for each drug or device product it distributes;

E. Provides verification of current FDA registration for each contract manufacturing facility listed;

F. If the contract manufacturer distributes into this State, provides the wholesale distributor permit number for the contract manufacturer;

G. If the contract manufacturer does not distribute into this State, provides name and Maryland's wholesale distributor permit number for the entity that physically distributes the product into this State;

H. Provides a statement affirming that the virtual manufacturer does not contract the manufacture or distribution for drugs or devices other than those for which it owns the NDA, ANDA, or UDI numbers;

I. Provides an attestation by the owner of the virtual manufacturer that it does not hold product;

J. Provides a copy of existing licensure from the state in which it is located, if applicable; and

K. Has valid federal licensure or registration, as verified by the Board.

Md. Code Regs. 10.34.22.03-1

Regulations .03-1 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulations .03-1 adopted effective April 7, 2008 (35:7 Md. R. 748)
Regulations .03-1, adopted effective 41:10 Md. R. 561, eff.7/1/2014