Texas Adopted & Proposed Rules

 

Adopted and Proposed Rules

Several TSBP Board Rules were adopted and proposed during the Board meeting on February 4, 2025.

View a summary of adopted and proposed rules.

Compounders sue FDA again over declaring end of shortage for Novo's semaglutide

 Compounders sue FDA again over declaring end of shortage for Novo's semaglutide

 

02/18/2025	02/06/2025	Tyche Industries Ltd	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/18/2025	02/05/2025	Jagsonpal Pharmaceuticals Limited	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceutical/Adulterated
02/18/2025	01/29/2025	AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
02/18/2025	02/10/2025	ABR Laboratory LLC	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceutical/Adulterated
02/18/2025	02/13/2025	Zenzi Pharmaceutical Industries Pvt. Ltd.	Center for Drug Evaluation and Research (CDER)	Refusal to Provide Access to and Copying of Records

 

02/11/2025	01/30/2025	Strukmyer LLC dba Strukmyer Medical	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
02/11/2025	02/04/2025	Wuhu Nuowei Chemistry Co., Ltd.	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/11/2025	02/04/2025	ISOThrive, Inc.	Center for Drug Evaluation and Research (CDER)	Clinical Investigator
02/11/2025	02/05/2025	Chengdu Innovation Pharmaceutical Co., Ltd.	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/04/2025	01/16/2025	Global Calcium Pvt. Limited	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/04/2025	01/28/2025	Shantou Kangjie Daily Chemical Industry Co., Ltd	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
02/04/2025	01/13/2025	Talla Imports, LLC	Office of Inspections and Investigations	Foreign Supplier Verification Program (FSVP)
02/04/2025	01/23/2025	Center for Instrumental Analysis of China Pharmaceutical University	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/04/2025	01/27/2025	Imperial Palace Commodity -Dongguan- Co., Ltd.	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterat

 

The Board of Pharmacy Specialties Announces Revised ...

Board of Pharmacy Specialties

https://bpsweb.org › 2025/01/30 › bps-announces-revise...

Jan 30, 2025 — The revised eligibility criteria will go into effect August 1, 2025. Eligibility criteria for board certification in Compounded Sterile Preparations Pharmacy ...

 

FDA releases guidance for compounding pharmacies

NCPA - National Community Pharmacists Association

https://ncpa.org › newsroom › qam › 2025/01/13 › fda-r...

Jan 13, 2025 — The FDA released revised guidance governing what substances pharmacies can compound. Under the guidance, 503A compounding pharmacies can continue to compound ...

 

Compounded Drug Guidance for Hospital and Health ...

JAMA Network

https://jamanetwork.com › journals › jama › fullarticle

by R Rubin · 2021 — The FDA would allow a hospital or health system pharmacy to distribute compounded drugs to health care facilities owned and operated by the same entity that ...

 

Integrating Analytical Procedures in Routine Practices ...

National Institutes of Health (NIH) (.gov)

https://pubmed.ncbi.nlm.nih.gov › ...

by RP Aquino · 2025 — Therefore, the residual compounded drugs are considered waste and a cost item that negatively affects the healthcare system. In the context of the ever- ...

 

Navigating the FDA's Final Interim Policy on Compounding ...

Buchanan Ingersoll & Rooney PC

https://www.bipc.com › ...

Jan 22, 2025 — The U.S. Food and Drug Administration (FDA or “the Agency”) has issued a final interim guidance on compounding practices involving bulk drug substances.

 

Terminal Distributor Requirements for Prescribers Engaged in ...

Ohio Board of Pharmacy (.gov)

https://www.pharmacy.ohio.gov › compoundrenew

PDF

Jan 13, 2025 — Compounding is defined as the “preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, ...