FDA compounding status
Methylcobalamin
Also listed as Methyl B12, Mecobalamin.
Methylcobalamin is in FDA's Category 1 for both 503A pharmacies and 503B outsourcing facilities. Category 1 means FDA is still evaluating the substance and has said it does not intend to take action against compounding with it while its interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Compounded methylcobalamin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
FDA lists it as "Methylcobalamin" in 503A Category 1 and as "Methylcobalamin/Methyl B12" in 503B Category 1.
Checked against the primary sources on .
The record
- FDA status
- FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
- Compounding basis
- 503A pharmacy (Category 1, interim policy)Compounded by a state-licensed 503A pharmacy against a patient-specific prescription. The substance is in FDA's 503A Category 1: FDA has said it does not intend to take action while the substance is under evaluation, if the interim policy's conditions are met. This is enforcement discretion, not the bulks list.
- 503B outsourcing facility (Category 1, interim policy)Compounded by a 503B outsourcing facility registered with FDA and inspected on a risk-based schedule. The substance is in FDA's 503B Category 1, under FDA's interim policy for substances under evaluation. This is enforcement discretion, not the bulks list.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Not named on the WADA 2026 Prohibited List.
- Offered by PEPLUX
- Yes, as Methylcobalamin B12
- Checked on
Offered by PEPLUX
Methylcobalamin B12
PEPLUX offers methylcobalamin as Methylcobalamin B12. The product page covers what it is, its risks, and how prescribing and pricing work.
Status as offered
In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.
Basis
What this status traces to.
FDA's 503A categories document (updated May 14, 2026) lists "Methylcobalamin" in Category 1, bulk drug substances under evaluation. FDA's 503B categories document (updated March 21, 2025) lists "Methylcobalamin/Methyl B12" in Category 1. Methylcobalamin is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDABulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Not named on the WADA 2026 Prohibited List.
Pending or unconfirmed
FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing methylcobalamin.
Common questions
Methylcobalamin, answered plainly.
- What is the FDA compounding status of Methylcobalamin?
- Methylcobalamin is in FDA's Category 1 for both 503A pharmacies and 503B outsourcing facilities. Category 1 means FDA is still evaluating the substance and has said it does not intend to take action against compounding with it while its interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Compounded methylcobalamin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
- What does the status of methylcobalamin trace to?
- FDA's 503A categories document (updated May 14, 2026) lists "Methylcobalamin" in Category 1, bulk drug substances under evaluation. FDA's 503B categories document (updated March 21, 2025) lists "Methylcobalamin/Methyl B12" in Category 1. Methylcobalamin is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway. Checked against the primary sources on October 13, 2026.
- Does PEPLUX offer methylcobalamin?
- PEPLUX offers methylcobalamin as Methylcobalamin B12. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.
- Is methylcobalamin prohibited in sport?
- Not named on the WADA 2026 Prohibited List.
- Is anything about the status of methylcobalamin pending or unconfirmed?
- FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing methylcobalamin.