Drug Establishment Annual Registration Status

$179 / year

The Drug Establishments Registration Site (DERS) is a database of information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S.Establishments must be registered within 5 days of beginning operations.

Complexity

Firms that send their initial or annual registrations from October 1st to December 31st period are considered registered until the end of the following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31.

Example 1: a new, updated or annual establishment registration Structured Product Labeling (SPL) is received on October 1. Registration is current through December 31, of the following year.

Example 2: a new, updated or annual establishment registration SPL is received on September 30, 2013. Registration is current through December 31, that same year. The renewal for the next period must be submitted between October 1 and December 31.

Regarding the effective time field in the annual establishment registration SPL, it should contain a reference to the year that is the same as the year you are submitting your SPL file.
For example, if a firm sends in an Establishment Registration SPL for 2014 on November 1, 2013 then the effective time field should be “20131101”.
21 Code of Federal Regulations (CFR) 207.21(a) and 207.40 and the United States Federal Food, Drug, and Cosmetic (FD&C) Act sections 510(c), (d), & (i)). In addition, establishments must renew registration annually between October 1st and December 31st of each year. (FD&C Act sections 510(b) & (i).

Date Created

2016-01

Last Modified

2017-02-03

Version

2017-02-03

Update Frequency

Irregular

Temporal Coverage

2017

Spatial Coverage

United States

Source

John Snow Labs; Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Drug Establishments Registration, Drug Establishment Database, Drugs Commercial Distribution, Structured Product Labeling, Drug Establishments, Drug Facilities Registration, Drug Facilities Status

Other Titles

Drugs Establishment Registration Status, Drug Facilities Registration Status

NameDescriptionTypeConstraints
FEI_NumberThe Facility FEI (FDA Establishment Identifier) Number data element is a number assigned by the FDA for tracking inspections.integerlevel : Nominal
DUNS_NumberThe Dun & Bradstreet D‑U‑N‑S Number is a unique identifier for businesses.integerlevel : Nominal
Firm_NameFirms name that sends their initial or annual registrationsstringrequired : 1
AddressFacility Addressstring-
OperationsOperations of the firmstring-
FEI_NumberDUNS_NumberFirm_NameAddressOperations
690359963Chrio Korea Co., Ltd2F, Anyang, - 431-060, KoreaMANUFACTURE
689846410Bekeikorea120 Toegye-ro, Jung-gu, Seoul, 04631, KoreaRELABEL
558528988MAMIBA33 Demeshk Street, Giza, 12411, Egypt (EGY)MANUFACTURE
689517176Yes Miracle Ltd40, Imi-ro, Uiwang, Gyeonggi 437120, KoreaRELABEL
270199391IFTSrue Marcel Pagnol, Foulayronnes, 47510, France (FRA)ANALYSIS
689060277HAIRJOY9 Dangjeongyeok-ro, Gunpo, Gyeonggi 15851, KoreaMANUFACTURE
689059857Herbearth104 Myeongdeok-ro, Nam-gu, Daegu, 42403, KoreaMANUFACTURE
480227248Ricola AgBaselstrasse 31, Laufen, 4242, Switzerland (CHE)MANUFACTURE
689846922NSB CO., LTD.36 Jandeung-ro, Dong-gu, Daegu, 41260, KoreaMANUFACTURE
689605985EDP Inc.291 Daehak-ro, Yuseong-gu, Taejon, Taejon 34141, KoreaRELABEL