Tuesday, May 14, 2024

 

Specialty lab exec gets 10-year prison term for 11 deaths ...

4 days ago — ... pharmacy executive Barry Cadden was sentenced to ... Compounding Center in Framingham, Massachusetts ... FBI, DOJ warn against threatening election workers .

PCCA's Motion to Dismiss for Want of Prosecution denied

 

in the united states district court

May 3, 2024 — Compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an ...

Court denies PCCA's Motion for Summary Judgment

 

Case 5:14-cv-00212-XR Document 218 Filed 04/30/24 ...

Apr 30, 2024 — The fraudulently reported ingredient prices were far more than the actual prices at which the Defendants sold ingredients to compounding pharmacies frequently ..

Maida Pharmacy, Inc. Agrees to Pay $25,000 to Resolve Allegations of Inadequate Recordkeeping

 BOSTON – The U.S. Attorney’s Office has reached a $25,000 settlement with the Arlington-based retail and compounding pharmacy Maida Pharmacy, Inc. (Maida) to resolve allegations that it failed to maintain adequate records of controlled substances and improperly disposed of controlled substances. 

 The Controlled Substances Act (the Act) regulates the manufacturing, purchasing, distribution and maintenance of certain controlled substances. Pursuant to the Act, Maida was required to keep records and follow security protocols for its controlled substances. 

As part of the settlement, Maida admitted that during an inspection, the Drug Enforcement Administration found that Maida did not have in place proper security protocols or maintain appropriate records for controlled substances. Maida also admitted that it had not conducted its mandatory inventory accountability audit and failed to maintain an appropriate security system for its controlled substances. Additionally, Maida admitted that, on several occasions, its employees disposed of Ketamine by placing it in the curbside trash, rather than properly destroying it in a manner consistent with the Act. 

Acting United States Attorney Joshua S. Levy and Brian D. Boyle, Special Agent in Charge of the Drug Enforcement Administration, Boston Field Division made the announcement today. Assistant U.S. Attorney Julien M. Mundele of the Affirmative Civil Enforcement Unit handled the case.

Updated May 1, 2024

 

Kentucky Board of Pharmacy

May 2, 2024 — Amendment filed April 15, 2024: This amendment creates a new type of pharmacist license for non-resident pharmacists. This is a limited license with a $50 ...

 

Compounded drug, not otherwise classified J7999 - HCPCS

Apr 22, 2024 — HCPCS Code J7999 for Compounded drug, not otherwise classified as maintained by CMS falls under Drugs, Not Otherwise Classified.

 

FDA, doctors warn about compounded Ozempic. What we ...

Apr 25, 2024 — The FDA says improperly compounded versions of the drug can have serious consequences. Channel 2 Action News went to several weight loss clinics across metro 

 

Bulk Drug Substances Reviewed and Not Listed

Apr 19, 2024 — Oral suspension, tablets, and capsules are on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals and ...

 

Intellectual Property Challenges for 503A Pharmacy ...

Apr 19, 2024 — ... compounded in large batches and not compounded in quantities beyond what is considered 'anticipatory' compounding. The pharmacy cannot be engaged in false ...

 

Guide: 503A Compounding

Apr 16, 2024 — The ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies provides an overview of FDA regulations and guidance necessary ...