Pharmaceuticals - Lentocilin and Extencilline
Waiver type - Procurement: Nonavailability
Agency: INDIAN HEALTH SERVICE (7527) • Product Service Code (PSC) : 6505 | Last Modified: 08/07/2025
Procurement Summary
The FDA has announced a shortage of Bicillin L-A (Penicillin G Benzathine Injection) with complete unavailability with the next delivery from Pfizer (domestic source) not being available until October 2025 and full recovery of March 2026. Bicillin L-A is used for the treatment of syphilis and being the sole treatment vector for infant syphilis. The FDA has approved the emergency importation and approval during the shortage of Lentocilin and Extencilline. Lentocilin is imported from Portugal and sold through Cost Plus Drug Company and Extencilline is imported from France through Prove Pharm. This procurement will allow for the National Supply Service Center to stockpile an emergent amount of the drugs through the continuity of the shortage. This will include stockpile and supply to all Indian Health Service facilities, tribally run facilities, and other Federal customers.
Waiver Rationale Summary
This waiver is only for the length of the FDA determined shortage of Penicillin G Benzathine Injection, Bicillin L-A, Injection, 1200000 [iU]/2 mL (NDC 60793-701-10). This is estimated to be remedied in March 2026. The National Supply Service Center has determined that 12,000 doses will be sufficient to reach that date and provide care to the American Indian/Alaska Native population.
Yes
No
Pending
DRUGS AND BIOLOGICALS
325412 - Pharmaceutical Preparation Manufacturing
08/07/2025
N/A
N/A
Pre-solicitation
Between 6 months and 1 year
Individual Waiver
INDIAN HEALTH SERVICE