- Drugs Establishment Registration Status
- Drug Facilities Registration Status
- Drug Establishments Registration
- Drug Establishment Database
- Drugs Commercial Distribution
- Structured Product Labeling
- Drug Establishments
- Drug Facilities Registration
- Drug Facilities Status
Drug Establishment Annual Registration Status
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.
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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).
About this Dataset
John Snow Labs; Food and Drug Administration (FDA);
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Drug Establishments Registration, Drug Establishment Database, Drugs Commercial Distribution, Structured Product Labeling, Drug Establishments, Drug Facilities Registration, Drug Facilities Status
Drugs Establishment Registration Status, Drug Facilities Registration Status
|FEI_Number||The Facility FEI (FDA Establishment Identifier) Number data element is a number assigned by the FDA for tracking inspections.||integer||level : Nominal|
|DUNS_Number||The Dun & Bradstreet D‑U‑N‑S Number is a unique identifier for businesses.||integer||level : Nominal|
|Firm_Name||Firms name that sends their initial or annual registrations||string||required : 1|
|Operations||Operations of the firm||string||-|
|FEI Number||DUNS Number||Firm Name||Address||Operations|
|117507545||Perfect Medics Inc.||800 Via Somonte, Palos Verdes Estates, California (CA) 90275, United States (USA)||LABEL|
|117508985||CANNAX USA, LLC||8465 W Sahara Ave Unit 1036, Las Vegas, Nevada (NV) 89117, United States (USA)||MANUFACTURE|
|117328269||MBK GROUP LLC||426 NW 10th AVE UNIT 426, HOMESTEAD, Florida (FL) 33030, United States (USA)||MANUFACTURE|
|81120876||F&A Specialty Foods, Inc.||2nd Fl E 53rd St, Chicago, Illinois (IL) 60707, United States (USA)||MANUFACTURE|
|801478103||WIZARD CREATIONS, INC||2765 W CYPRESS CREEK RD STE B, FORT LAUDERDALE, Florida (FL) 33309, United States (USA)||MANUFACTURE|
|405.0||988899845||Baxter Healthcare S.A.||Moneen Road, Castlebar, County Mayo F23 XR63, Ireland (IRL)||ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE|
|1073.0||690535893||Alps Pharmaceutical Ind. Co., Ltd.||2-10-50, FURUKAWACHOMUKAIMACHI, Hida-shi, Gifu 509-4241, Japan (JPN)||API MANUFACTURE|
|1379.0||313113144||Dynamit Nobel GmbH Explosivstoff- und Systemtechnik||Kalkstr. 218, Leverkusen, 51377, Germany (DEU)||ANALYSIS; API MANUFACTURE|
|1463.0||291538267||Sanofi Chimie||Vertolaye, Vertolaye, 63480, France (FRA)||ANALYSIS; API MANUFACTURE|
|6898.0||810432484||Baxter, S.A. de C.V.||Av. de Los 50 Metros No. 2, Jiutepec, Morelos 62578, Mexico (MEX)||ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; STERILIZE|