Availability of STI Testing & Treatment Products
- Visit the FDA’s Drug Shortages page for information on all current and resolved drug shortages and discontinuations reported to the U.S. Food & Drug Administration (FDA).
- Notify DSTDP (firstname.lastname@example.org) of any shortage or low inventories of STI treatments in your jurisdiction so CDC can continue monitoring treatment availability.
The FDA has listed penicillin G benzathine injectable suspension products (Bicillin L-A®) on their drug shortage webpage, noting limited supply due to increased demand. In addition, the FDA website includes an expected duration for the shortage. CDC continues to monitor the situation and will post updates as needed.
On 1/16/2024, the FDA announced that they have exercised enforcement discretion for a temporary importation and use of Extencillin (benzathine benzylpenicillin injection, powder, for suspension) to mitigate the effects of the Bicillin L-A® drug shortage. See more in this CDC letter.
Bicillin L-A® is the first-line recommended treatment for syphilis and the only recommended treatment option for some patients.
During this time, programs can see Clinical Reminders during Bicillin L-A® Shortage for priority actions they can take.
On January 21, 2022, the Food and Drug Administration (FDA) reported a shortage of cefixime capsules. Cefixime is an oral medication that can be used as an alternative regimen for the treatment of uncomplicated gonococcal infection of the cervix, urethra, or rectum if the recommended regimen is not available or not feasible. Currently, there is no recommended alternative oral gonorrhea regimen. If cefixime is not available, ceftriaxone, intramuscularly is the recommended treatment. Additional treatment guidance can be found in the CDC’s STI Treatment Guidelines, 2021. For more information regarding the availability of cefixime, visit the FDA Drug Shortage Website.
On July 7, 2022, the Food and Drug Administration (FDA) reported a shortage of erythromycin ophthalmic ointment. Please see the FDA Drug Shortages page about the erythromycin ophthalmic ointment shortage.
Erythromycin 0.5% ophthalmic ointment is the only recommended regimen to prevent ophthalmia neonatorum caused by N. gonorrhoeae.
If erythromycin ointment is unavailable, infants at risk for exposure to N. gonorrhoeae, especially those born to a mother at risk for gonococcal infection or with no prenatal care, can be administered ceftriaxone 25–50 mg/kg body weight IV or IM, not to exceed 250 mg in a single dose.
Other topical medications are not recommended: tetracycline ophthalmic ointment and silver nitrate are no longer available in the United States; gentamicin was associated with chemical conjunctivitis during the last erythromycin shortage; and povidone-iodine has limited data on its benefits and harms.
Most importantly, gonorrhea ocular prophylaxis of newborns is mandated by law in most states and is considered standard neonatal care. This prophylaxis is consistent with USPSTF recommendations.
It is also important to remember that prenatal screening is the best method for preventing gonococcal ophthalmia neonatorum among newborns! Therefore, all pregnant women < 25 years and women > 25 at increased risk should be screened for N. gonorrhoeae at the first prenatal care visit and again in the third trimester if the risk continues during pregnancy. Also, all females treated for gonorrhea should be retested 3 months following treatment.
Additional treatment guidance is available in the CDC’s STI Treatment Guidelines, 2021.
Notify your local health department of any challenges in procuring the product. In addition, current information regarding the availability of erythromycin (0.5%) ophthalmic ointment is available on the FDA Drug Shortage page.
On 7/23/2021, the Food and Drug Administration (FDA) reported a shortage of gentamicin sulfate injection (80mg per 2ml). In combination with azithromycin, Gentamicin is an alternative regimen for use if ceftriaxone unavailable for uncomplicated gonococcal infection of the cervix, urethra, or rectum among adults and adolescents. In addition, gentamicin, combined with azithromycin, can be considered an alternative to ceftriaxone for persons with cephalosporin allergy. Treatment regimens for gonorrhea are outlined in the 2021 STI Treatment Guidelines. The product is available or in limited supply from one of the manufacturers. For more information regarding the availability of gentamicin, visit the FDA Drug Shortage Website