How FDA's latest compounding guidance affects ...

VIN

https://news.vin.com › ...

7 days ago — Preparing a compounded preparation may begin with FDA-approved finished drug products; or active pharmaceutical ingredients, commonly called bulk drug ...

Bulk Drug Substances Currently Under Review

Food and Drug Administration (.gov)

https://www.fda.gov › animal-drug-compounding › b...

4 days ago

Bulk Drug Substance (BDS)	Species	Nomination
Acepromazine maleate	dog, cat, horse	FDA‑2018‑N‑4626‑0114
Acetyl‑D‑glucosamine	dog, horse	FDA‑2018‑N‑4626‑0104
Actinomycin D	dog, cat	FDA‑2018‑N‑4626‑0106

 

FDA Approves First Generic Flumethasone for Certain Anti-inflammatory Responsive Diseases in Cats, Dogs and Horses

Today the U.S. Food and Drug Administration approved Bimasone Injectable Solution, the first generic flumethasone, for certain diseases that cause inflammation in horses, dogs, and cats. Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states that are known to be responsive to anti-inflammatory drugs (i.e., corticoids) in these species.

Bimasone is a corticosteroid drug. It contains the same active ingredient (flumethasone) in the same concentration and dosage form as the approved brand name drug product, Flucort, which was first approved for use in horses, dogs, and cats on October 21, 1965.

 

• American Bangster Optimum Formula 3000 contains hidden drug ingredient
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503B Outsourcing Facilities Batting 1 for 11 in This Round ...

Lachman Consultants

https://www.lachmanconsultants.com › Blog

2 days ago — The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be ...

 

Drug Supply Chain Security Act (DSCSA) – Key Terms

Cardinal Health

https://www.cardinalhealth.com › web › literature

2 days ago — implementation of the Drug Supply Chain Security Act (DSCSA). ... certain intravenous product, any medical gas, homeopathic drugs or compounded drugs

 

RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE

Ohio.gov

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

3 days ago — license in state where pharmacy is located and. Ohio RPH license if shipping compounded medications. May include compounding. Non-Resident. (OAC 4729:5-8).

Irvine pharmacist sentenced 15 years for her role in $11- ... Los Angeles Times https://www.latimes.com › daily-pilot › news › story › ir... 4 days ago — Compounded drugs are tailor-made products doctors may prescribe whe

 

Irvine pharmacist sentenced 15 years for her role in $11- ...

Los Angeles Times

https://www.latimes.com › daily-pilot › news › story › ir...

4 days ago — Compounded drugs are tailor-made products doctors may prescribe whe

15 year sentence for pharmacist involved in compounded drug scheme

 

Orange County pharmacist sentenced to 15 years for her ...

Orange County Register

https://www.ocregister.com › 2023/04/03 › orange-co...

4 days ago — Compounded drugs are tailor-made products doctors may prescribe when the Food and Drug Administration-approved alternative does not meet the health needs of a ...

 

How FDA's latest compounding guidance affects ...

VIN

https://news.vin.com › ...

2 hours ago — In addition to curtailing office-stock use of medications compounded from bulk drug substances, the FDA guidance calls for more documentation when such drugs .

 

List of Bulk Drug Substances for Which There Is a Clinical ...

Federal Register (.gov)

https://www.federalregister.gov › 2023/04/06 › list-of-...

1 day ago — Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, .