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 (stdshortages@cdc.gov) 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.

Since 2022, multiple pharmaceutical companies have discontinued (Padagis US) or decreased manufacturing and distribution (Bausch Health America and Armas Pharmaceutical) of erythromycin ointment (0.5%) in the US. To help mitigate these shortages, the FDA has approved a temporary importation of limited quantities of erythromycin ophthalmic ointment (0.5%) from Canada’s Steri-Med Pharma.

The most important strategy to prevent gonorrhea and chlamydia in neonates is through prenatal screening and treatment during pregnancy. This guidance is intended to be used in addition to prenatal screening and monitoring of all neonates for signs of ophthalmia neonatorum.

Erythromycin 0.5% ophthalmic ointment is the only recommended regimen to prevent ophthalmia neonatorum caused by Neisseria gonorrhoeae. However, alternative options can be considered during this shortage.

If erythromycin ophthalmic ointment (0.5%) is available, please continue to provide ointment to all neonates within 24 hours of birth.

If erythromycin ophthalmic ointment (0.5%) is unavailable, consider one of the following three options:

**Alternative Prevention Method Option #1:** Azithromycin ophthalmic solution 1% can be considered as an alternative regimen, given to all neonates within 24 hours of birth
Azithromycin ophthalmic solution 1%	Place 1-2 drops in the conjunctival sac of each eye, taking care to not touch the vial to the neonate Since this is a solution (and not an ointment), it is important that drops are placed properly

Special considerations:

There are no data on efficacy of this medication for ophthalmia neonatorum prevention; this alternative prevention method is based on available pharmacology data, limited prior use, and expert opinion
Ophthalmia neonatorum prophylaxis is an off-label use of this medication, but should not preclude its use
Azithromycin ophthalmic solution 1% can be costly

**Alternative Prevention Method Option #2:** Test all birthing parents for gonorrhea and chlamydia at time of delivery and provide treatment only to neonates and birthing parents who test positive.
Test all birthing parents at time of delivery and treat all neonates from birth parents who test positive	Ceftriaxone 25–50 mg/kg body weight IV or IM, not to exceed 250 mg in a single dose or Cefotaxime 100 mg/kg body weight IV or IM as a single dose (when ceftriaxone cannot be given: e.g., simultaneous administration of IV calcium)

Note: This option requires communication between the providers who are providing care to the birthing parent and the providers who are providing care to the newborn to ensure follow-up of laboratory tests performed at delivery, and if positive, prompt appropriate treatment of the newborn and birthing parent.

**Alternative Prevention Method Option #3:** Empirically treat all neonates at high risk for exposure to *N. gonorrhoeae* (e.g., neonates born to birthing parents without prenatal care, with a history of sexually transmitted infections during pregnancy, or with a history of substance use).
Empirically treat all neonates at high risk of gonorrhea	Ceftriaxone 25–50 mg/kg body weight IV or IM, not to exceed 250 mg in a single dose or Cefotaxime 100 mg/kg body weight IV or IM as a single dose (when ceftriaxone cannot be given: e.g., simultaneous administration of IV calcium)

Please consider your local populations, resources, and policies when selecting alternative methods of ophthalmia neonatorum prevention.

If you need clinical decision-making support, you can contact the STD Clinical Consultation Network.

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

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Availability of STI Testing & Treatment Products

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