e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

e-CFR data is current as of July 10, 2020

Title 21Chapter ISubchapter DPart 310Subpart D → §310.306

Title 21: Food and Drugs
Subpart D—Records and Reports

§310.306   Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.

(a) Applicability. Marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application are subject to this section.

(b) Notification of a permanent discontinuance or an interruption in manufacturing. The manufacturer of each product subject to this section must make the notifications required under §314.81(b)(3)(iii) of this chapter and otherwise comply with §314.81(b)(3)(iii) of this chapter. If the manufacturer of a product subject to this section fails to provide notification as required under §314.81(b)(3)(iii), FDA will send a letter to the manufacturer and otherwise follow the procedures set forth under §314.81(b)(3)(iii)(e).

(c) Drug shortages list. FDA will include on the drug shortages list required by §314.81(b)(3)(iii)(d) drug products that are subject to this section that it determines to be in shortage. For such drug products, FDA will provide the names of each manufacturer rather than the names of each applicant. With respect to information collected under this paragraph, FDA will observe the confidentiality and disclosure provisions set forth in §314.81(b)(3)(iii)(d)(2).

[80 FR 38938, July 8, 2015]

Need assistance?