Section 22-B10826. NOTIFICATION BY THE MANUFACTURER TO AFFECTED PERSONS

 

10826.1The notification to the persons specified in § 10823.1(b) shall be in writing and, in addition to other relevant information which the Department may require, shall include:

 

(a) The information prescribed by § 10825.1(a) and (d), as well as instructions with respect to the use of the product pending the correction of the defect;

 

(b) A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply;

 

(c) The following statement:

 

“The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable District of Columbia standard in accordance with a plan to be approved by the Department of Health, the details of which will be included in a subsequent communication to you.”; and

 

(d) Provided, that if at the time the notification is sent, the Department has approved a plan for the repair, replacement, or refund of the product, the notification may include the details of the approved plan in lieu of the above statement.

 

10826.2The envelope containing the notice shall not contain advertising or other extraneous material, and such mailings will be made in accordance with this section.
 

10826.3Number 10 white envelopes shall be used, and the name and address of the manufacturer shall appear in the upper left corner of the envelope.

 

10826.4The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle three and three-fourths inches (3 ¾ in.) wide and two and one-quarter inches (2 ¼ in.) high:

“Important--Electronic Product Radiation Warning”

 

10826.5The statement shall be in three (3) lines, all capitals, and centered. "Important" shall be in thirty six (36) point Gothic Bold type. "Electronic Product" and "Radiation Warning" shall be in thirty six (36) point Gothic Condensed type.

 

10826.6Envelopes with markings similar to those prescribed in this section shall not be used by manufacturers for mailings other than those required by this chapter.
 

10826.7The notification shall be sent:

 

(a)By certified mail to purchasers of the product and to subsequent transferees;
 

(b)By certified mail or other more expeditious means to dealers and distributors; and

 

(c)Where products were sold under a name other than that of the manufacturer of the product, the name of the individual or company under whose name the product was sold may be used in the notification required by this section.

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).