Outsourcing Facilities Association et al v. United States Food and Drug Administration et al
| Outsourcing Facilities Association and North American Custom Laboratories, LLC doing business as Farmakeio Custom Compounding |
| United States Food and Drug Administration and Dr. Robert M Califf |
| 4:2024cv00953 |
| October 7, 2024 |
| U.S. District Court for the Northern District of Texas |
| Mark Pittman |
| Other Statutes: Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 551 Administrative Procedure Act |
| None |
Docket Report
RSS Track this Docket
This docket was last retrieved on May 13, 2025. A more recent docket listing may be available from PACER.
| Document Text |
|---|
Filing 31
ORDER: The Court concludes there is good cause to continue the stay and ORDERS that the Parties file a second joint status report on or before December 19, 2024. (Ordered by Judge Mark Pittman on 11/22/2024) (saw)
|
|
Filing 30
Joint STATUS REPORT filed by United States Food and Drug Administration, Robert M Califf. (McDonald, Oliver)
|
|
Filing 29
ORDER: This case should be, and it is hereby, ADMINISTRATIVELY CLOSED. This case may be reopened, without prejudice, upon motion by either party. The Clerk of Court is DIRECTED to administratively close this case until further notice. (Ordered by Judge Mark Pittman on 10/16/2024) (saw)
|
|
Case Stayed, Hearing/Deadline Modification per 28 Electronic Order: Status Report due by 11/21/2024. The hearing in this case scheduled for October 15, 2024, at 11:00 a.m. is canceled. (jnp) Modified file date and document linkage on 10/15/2024 (jnp).
|
|
Filing 28
ELECTRONIC ORDER granting #27 Defendants' Unopposed Motion for Voluntary Remand and Stay (ECF No. 27). The Court has considered the motion in light of the governing standard. The Court has also taken into account Defendants' representation that they will not take action against Plaintiffs and their members for violations of the Federal Food, Drug, and Cosmetic Act arising from conditions that depend on tirzepatides inclusion on the drug shortage list (i.e., compounding that does not meet the applicable conditions in 21 U.S.C. 353a(b)(1)(D) or 353b(a)(2)(A)(ii) and (a)(5)), from the date of this order through two weeks beyond the new decision on remand and, if Plaintiffs file a motion for preliminary injunction regarding the new decision, through the Courts resolution of that motion. It is hereby ORDERED that: 1. The case is stayed and the challenged decision is remanded to the United States Food and Drug Administration for reconsideration; 2. The parties shall file a joint status report by November 21, 2024; 3. The hearing in this case scheduled for October 15, 2024, at 11:00 a.m. is canceled. (Ordered by Judge Mark Pittman on 10/11/2024) (JRG)
|
|
Filing 27
Unopposed MOTION to Remand to U.S Food and Drug Administration and to Stay Case filed by Robert M Califf, United States Food and Drug Administration with Brief/Memorandum in Support. (Attachments: #1 Proposed Order) (McDonald, Oliver)
|
|
Filing 26
NOTICE of Attorney Appearance by Oliver McDonald on behalf of Robert M Califf, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (McDonald, Oliver)
|
|
Filing 25
ORDER: Before the Court is Plaintiffs' Emergency Motion for a Temporary Restraining Order. ECF No. #7 . The Court finds it necessary to set a hearing on the matter. The Court hereby SETS the Motion for a hearing at 11:00 a.m. on October 15, 2024, in the Fourth Floor Courtroom of the Eldon B. Mahon United States Court, 501 W 10th St., Fort Worth, Texas, 76102. All counsel for Parties are ORDERED to attend. (Ordered by Judge Mark Pittman on 10/10/2024) (saw)
|
|
Filing 24
NOTICE of Attorney Appearance by Jeremy B Kustoff on behalf of Outsourcing Facilities Association. (Filer confirms contact info in ECF is current.) (Kustoff, Jeremy)
|
|
Filing 23
NOTICE of Attorney Appearance by David Hixson on behalf of Robert M Califf, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (Hixson, David)
|
|
Filing 22
NOTICE of Attorney Appearance by Kimberly Ruthsatz Stephens on behalf of Robert M Califf, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (Stephens, Kimberly)
|
|
Filing 21
ELECTRONIC ORDER granting #18 Application for Admission Pro Hac Vice of Marc N. Wagner. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Mark Pittman on 10/9/2024) (WRA)
|
|
Filing 20
ELECTRONIC ORDER granting #17 Application for Admission Pro Hac Vice of Renee M. Knudsen. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Mark Pittman on 10/9/2024) (WRA)
|
|
Filing 19
ELECTRONIC ORDER granting #16 Application for Admission Pro Hac Vice of Richard B. Raile. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Mark Pittman on 10/9/2024) (WRA)
|
|
Filing 18
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Marc N. Wagner (Filing fee $100; Receipt number ATXNDC-14978871) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit A - Certificate of Good Standing) (Doyle, Tyler)
|
|
Filing 17
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Renee M. Knudsen (Filing fee $100; Receipt number ATXNDC-14978625) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit A - Additional Courts, #3 Exhibit B - Certificate of Good Standing) (Doyle, Tyler)
|
|
Filing 16
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Richard B. Raile (Filing fee $100; Receipt number ATXNDC-14978610) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit A - Additional Courts, #3 Exhibit B - Certificate of Good Standing) (Doyle, Tyler)
|
|
Filing 15
ELECTRONIC ORDER granting #13 Application for Admission Pro Hac Vice of Andrew M. Grossman. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Mark Pittman on 10/9/2024) (JRG)
|
|
Filing 14
ELECTRONIC ORDER denying #12 Motion for Leave to proceed without local counsel. (Ordered by Judge Mark Pittman on 10/9/2024) (JRG)
|
|
Filing 13
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Andrew M. Grossman (Filing fee $100; Receipt number ATXNDC-14978198) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit A - Additional Courts, #3 Exhibit B - Certificate of Good Standing) (Doyle, Tyler)
|
|
Filing 12
MOTION for Leave to File /Waive Local Counsel Requirement filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association with Brief/Memorandum in Support. (Attachments: #1 Proposed Order) (Doyle, Tyler)
|
|
Filing 11
NOTICE of Compliance (Transmission of Briefing Schedule to Defendants) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Doyle, Tyler)
|
|
Filing 10
ORDER: Before the Court is Plaintiffs' Emergency Motion for a Temporary Restraining Order. ECF No. #7 . It is ORDERED that Defendants' response is due on or before Friday, October 11, 2024, and Plaintiffs' reply is due on or before Tuesday, October 15, 2024. (Ordered by Judge Mark Pittman on 10/8/2024) (saw)
|
|
Filing 9
Appendix in Support filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association re #7 Emergency MOTION for Temporary Restraining Order and Preliminary Injunction (Doyle, Tyler)
|
|
Filing 8
Brief/Memorandum in Support filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association re #7 Emergency MOTION for Temporary Restraining Order and Preliminary Injunction (Doyle, Tyler)
|
|
Filing 7
Emergency MOTION for Temporary Restraining Order and Preliminary Injunction filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order (TRO), #2 Proposed Order (Preliminary Injunction)) (Doyle, Tyler)
|
|
Filing 6
Summons issued as to Robert M Califf, United States Food and Drug Administration, U.S. Attorney, and U.S. Attorney General. (saw)
|
|
Filing 5
New Case Notes: A filing fee has been paid. File to: Judge Pittman. Pursuant to Misc. Order 6, Plaintiff is provided the Notice of Right to Consent to Proceed Before A U.S. Magistrate Judge. Clerk to provide copy to plaintiff if not received electronically. Attorneys are further reminded that, if necessary, they must comply with Local Rule 83.10(a) within 14 days or risk the possible dismissal of this case without prejudice or without further notice. (saw)
|
|
Filing 4
CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by North American Custom Laboratories, LLC d/b/a Farmakeio Custom Compounding, Outsourcing Facilities Association. (Clerk QC note: Affiliate entry indicated). (Doyle, Tyler)
|
|
Filing 3
Request for Clerk to issue Summons to Dr. Robert M. Califf filed by North American Custom Laboratories, LLC d/b/a Farmakeio Custom Compounding, Outsourcing Facilities Association. (Doyle, Tyler)
|
|
Filing 2
Request for Clerk to issue Summons to United States Food and Drug Administration filed by North American Custom Laboratories, LLC d/b/a Farmakeio Custom Compounding, Outsourcing Facilities Association. (Doyle, Tyler)
|
|
Filing 1
COMPLAINT against Robert M Califf, United States Food and Drug Administration filed by Outsourcing Facilities Association, North American Custom Laboratories, LLC d/b/a Farmakeio Custom Compounding. (Filing fee $405; Receipt number ATXNDC-14973162) Plaintiff will submit summons(es) for issuance. In each Notice of Electronic Filing, the judge assignment is indicated, and a link to the # Judges Copy Requirements and # Judge Specific Requirements is provided. The court reminds the filer that any required copy of this and future documents must be delivered to the judge, in the manner prescribed, within three business days of filing. Unless exempted, attorneys who are not admitted to practice in the Northern District of Texas must seek admission promptly. Forms, instructions, and exemption information may be found at www.txnd.uscourts.gov, or by clicking here: # Attorney Information - Bar Membership. If admission requirements are not satisfied within 21 days, the clerk will notify the presiding judge. (Attachments: #1 Cover Sheet, #2 Exhibit A, #3 Exhibit B) (Doyle, Tyler)
|
Access additional case information on PACER
Use the links below to access additional information about this case on the U.S. Court's PACER system. A subscription to PACER is required.
Access this case on the Texas Northern District Court's Electronic Court Filings (ECF) System
- Search for Party Aliases
- Associated Cases
- Attorneys
- Case File Location
- Case Summary
- Docket Report
- History/Documents
- Parties
- Related Transactions
- Check Status
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
