Thursday, December 2, 2021

 

2 days ago — Louisville Pharmacist Sentenced to Federal Prison for Health Care Fraud Scheme Involving Pain Cream Prescriptions. November 19, 2021.

 

2 days ago — On appeal, Liberty Mutual argued that the pharmacies misrepresented their pain creams as compounded drugs that are custom-made for each patient, ...

 


BOARD REVISES PROCESS FOR APPROVAL OF PHARMACIST:TECHNICIAN RATIO REQUESTS.  The North Carolina Pharmacy Practice Act provides that “a pharmacist may not supervise more than two pharmacy technicians unless the pharmacist-manager receives written approval from the Board.  The Board may not allow a pharmacist to supervise more than two pharmacy technicians unless the additional pharmacy technicians are certified pharmacy technicians.”  G.S. 90-85.15A(c)).  In light of changes to the North Carolina Pharmacy Practice Act granting qualified pharmacy technicians the authority to administer certain vaccines under pharmacist supervision, and (effective February 1, 2022) expansion of pharmacist’s ability to initiate and modify certain drug therapies, the Board has modified its process for reviewing and approving pharmacist:technician ratio requests.

A pharmacist-manager’s request for a 1:3, 1:4, or 1:5 pharmacist:technician ratio may be allowed by Board staff without formal Board action as long as the pharmacist-manager demonstrates that the pharmacy employs a sufficient number certified technicians to meet the ratio.  A pharmacist-manager’s request for a 1:6 or higher pharmacist:technician ratio must be considered by the full Board.

More detail on the Board’s revised process, as well as instructions on how to submit a pharmacist:technician ratio request, is found here.


quoted from http://www.ncbop.org/

 

4 days ago — Sterile compounding is an essential component of pharmacy practice for pharmacists and pharmacy technicians and efforts to identify and reduce potential ...

 

3 days ago — Compounding expert Dr. Annie Lambert reviews what the proposed FDA draft guidance will mean for your facility.

 

Monday, November 29, 2021

 

6 days ago — FDA received case reports of TASS (Toxic Anterior Segment Syndrome) following intraocular administration of compounded drugs using moxifloxacin as a bulk ...

Tuesday, November 23, 2021

 

10 hours ago — the new rules, a non-resident compounding pharmacy must have an Ohio licensed pharmacist as the responsible person on its Ohio terminal distributor license

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

 

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Lack of sterility assurance
Company Name:
Sagent Pharmaceuticals, Inc.
Brand Name:
Sagent
Product Description:
Levetiracetam Injection

Company Announcement

CHICAGO, IL – November 19, 2021 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.

Risk Statement: Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening.  To date, Sagent has not received reports of any product complaints or adverse events associated with this issue.

Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.  Product was distributed Nationwide from March to November  2021.

Product

Lot
Number

Expiration Date

NDC Number

Distribution Dates

 Levetiracetam Injection, USPB0G85VBJun-202225021-
780-05
May 2021 -
August 2021
B0K88VASep-2022March 2021 -
November 2021
B0K89VASep-2022August 2021 -
November 2021
B1G194AJun-2023October 2021 

Sagent Pharmaceuticals, Inc.  is notifying customers by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product. Customers that have Levetiracetam Injection, USP 500mg per 5 mL, which is being recalled, have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Healthcare/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form to document product information, as well as other information regarding this recall, is available at www.Sagentpharma.comExternal Link Disclaimer.

Consumers or healthcare workers with any questions regarding this recall can contact the customer call center (866) 625-1618 M-F, 8am-7pm CST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Customer Call Center
 (866) 625-1618

Product Photos

 "Nov. 2, 2021: Update – In October 2020, FDA was sued by seven compounding pharmacies in the U.S. District Court for the District of Columbia regarding the final standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products. In September 2021, the Court remanded the MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. FDA is evaluating the Court’s decision.

Before the Court’s decision, FDA extended the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the  final standard MOU, to October 27, 2022.

FDA plans to provide additional updates, as appropriate, with regard to the MOU."


quoted from https://www.fda.gov/drugs/human-drug-compounding/memorandum-understanding-addressing-certain-distributions-compounded-drugs