Section 22-B10317. OTHER EXEMPTIONS - MEDICAL DEVICES: PROCESSING, LABELING, OR REPACKING

 

10317.1Except as provided by §§ 10317.2 and 10317.3, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of 21 U.S.C. §§ 352(b) and (f) if:

 

(a)The person who introduced such shipment or delivery into interstate  commerce is the operator of the establishment where such device is to be  processed, labeled, or repacked; or

 

(b)In case such person is not such operator, such shipment or delivery is  made to such establishment under a written agreement, signed by and  containing the post office addresses of such person and such operator, and  containing such specifications for the processing, labeling, or repacking,  as the case may be, of such device in such establishment as will ensure, if  such specifications are followed, that such device will not be adulterated  or misbranded within the meaning of the Act upon completion of such  processing, labeling, or repacking. Such person and such operator shall  each keep a copy of such agreement until two (2) years after the final  shipment or delivery of such device from such establishment, and shall  make such copies available for inspection at any reasonable hour to any  officer or employee of the Department who requests them.

 

10317.2An exemption of a shipment or other delivery of a device under § 10317.1(a) shall not apply if, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the Act when so removed.

 

10317.3An exemption of a shipment or other delivery of a device under § 10317.1(b) shall not apply with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by § 10317.1(b).

 

10317.4An exemption of a shipment or other delivery of a device under § 10317.1(b) shall expire:

 

(a)At the beginning of the act of removing such shipment or delivery, or any  part thereof, from such establishment if the device comprising such  shipment, delivery, or part is adulterated or misbranded within the  meaning of the Act when so removed; or

 

(b)Upon refusal by the operator of the establishment where such device is to  be processed, labeled, or repacked, to make available for inspection a copy  of the agreement, as required by § 10317.1(b).

 

10317.5Because of common industry practice to manufacture or assemble, package, and fully label a device as sterile at one (1) establishment and then ship such device in interstate commerce to another establishment or to a contract sterilizer for sterilization, the Department of Health will initiate no regulatory action against the device as misbranded or adulterated when the non-sterile device is labeled sterile, provided all the following conditions are met:

 

(a)There is in effect a written agreement which:

 

(1)Contains the names and post office addresses of the firms involved  and is signed by the person authorizing such shipment and the  operator or person in charge of the establishment receiving the  devices for sterilization;

 

(2)Provides instructions for maintaining proper records or otherwise  accounting for the number of units in each shipment to ensure that  the number of units shipped is the same as the number received  and sterilized;

 

(3)Acknowledges that the device is non-sterile and is being shipped  for further processing; and

 

(4)States in detail the sterilization process, the gaseous mixture or  other media, the equipment, and the testing method or quality  controls to be used by the contract sterilizer to assure that the  device will be brought into full compliance; and

 

(b) Each pallet, carton, or other designated unit is conspicuously marked to  show its non-sterile nature when it is introduced into and is moving in  interstate commerce, and while it is being held prior to sterilization.  Following sterilization, and until such time as it is established that the  device is sterile and can be released from quarantine, each pallet, carton,  or other designated unit is conspicuously marked to show that it has not  been released from quarantine (for example, "sterilized--awaiting test  results" or an equivalent designation).

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).