FDA Drug Shortage: Acetaminophen; Oxycodone Hydrochloride Tablet (To Be Discontinued)

FDA reported on January 15, 2025 that Acetaminophen; Oxycodone Hydrochloride Tablet is in shortage and will be discontinued. Wholesale drug distributors and specialty pharmacy operations should prepare for supply chain adjustments as manufacturers exit this product line.

Background

FDA maintains the Drug Shortages Database under Section 506C-1 of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) in 2012 and further strengthened by the Coronavirus Aid, Relief, and Economic Security (CARES) Act in 2020. The agency tracks shortages of medically necessary drugs and biologics, focusing on products where a disruption would significantly impact patient care.

Acetaminophen with Oxycodone Hydrochloride is a Schedule II controlled substance under the Controlled Substances Act (21 U.S.C. 812). Wholesale distributors handling this product must maintain DEA registration and comply with both FDA wholesale distributor requirements under 21 CFR Part 205 and DEA security and recordkeeping requirements under 21 CFR Part 1301.

Key Details

Product Identification:

• Generic Name: Acetaminophen; Oxycodone Hydrochloride
• Dosage Form: Tablet
• Shortage Status: To Be Discontinued
• Report Date: January 15, 2025

Supply Status:

FDA classifies this as a discontinuation rather than a temporary shortage. Manufacturers have notified FDA of their intent to cease production. Current inventory levels and specific discontinuation timelines were not disclosed in the public shortage report.

Alternative Products:

Other manufacturers produce Acetaminophen; Oxycodone Hydrochloride tablets in various strengths. FDA has not indicated that the discontinuation will result in a market-wide shortage, suggesting sufficient alternative supply exists. Distributors should verify alternative manufacturer availability and confirm active FDA establishment registrations for substitute products.

Impact Assessment

For Wholesale Drug Distributors:

Entities holding inventory of the discontinued product must manage controlled substance inventory drawdown in compliance with DEA regulations. Under 21 CFR 1301.76, registrants must conduct biennial controlled substance inventories and maintain perpetual records for Schedule II substances. Discontinued product inventory must be reconciled against DEA 222 forms (or CSOS electronic orders) and either distributed to licensed purchasers or returned to manufacturers before the product becomes unavailable.

State boards of pharmacy may require notification when a distributor can no longer supply a previously stocked controlled substance. Distributors should review jurisdiction-specific reporting requirements.

For Specialty Pharmacy Operations:

Specialty pharmacies dispensing combination opioid products must coordinate with distributors to transition to alternative manufacturers. This requires verifying that substitute products carry the same NDC-based prior authorization approvals and meet payer formulary requirements. Patient continuity protocols should be established before current stock depletes.

For 3PLs and Cold Chain Providers:

While Acetaminophen; Oxycodone Hydrochloride tablets are not cold chain products, 3PLs providing warehousing for controlled substances must ensure discontinued inventory is handled according to client instructions and DEA security requirements under 21 CFR 1301.71-76. Physical inventory reconciliation becomes critical during product phase-outs to prevent diversion risk.

DSCSA Implications:

Under the Drug Supply Chain Security Act (21 U.S.C. 360eee), wholesale distributors must maintain transaction history, transaction information, and transaction statements for the discontinued product until the later of six years or the product's expiration date. Discontinuation does not eliminate DSCSA traceability obligations for units already in the distribution chain.

Distributors should confirm whether manufacturers will continue accepting returns of expired or damaged product after discontinuation. DSCSA product identifiers (serialized NDCs) must remain traceable through the returns process. For comprehensive DSCSA compliance requirements, see the DSCSA compliance checklist for wholesale distributors.

What ColdChainCheck Data Shows

ColdChainCheck tracks 1,275 wholesale drug distributors, 3PLs, and cold chain providers across 51 jurisdictions. Of these entities, 1,234 hold current FDA establishment registrations — the baseline requirement for handling prescription drug products, including discontinued controlled substances like Acetaminophen; Oxycodone Hydrochloride tablets.

The directory's average compliance score of 51/100 places the industry in the "Fair" tier, meaning most entities maintain basic licensure and registration but lack comprehensive accreditation signals. Only 63 entities hold NABP accreditation (formerly VAWD), which includes enhanced verification of controlled substance handling procedures. For entities managing Schedule II product discontinuations, NABP accreditation provides an additional compliance signal beyond state licensure.

73 entities in the ColdChainCheck directory have at least one FDA recall or enforcement action on record. While not all recalls relate to controlled substance handling, the presence of enforcement history indicates compliance gaps that may complicate inventory reconciliation during product phase-outs. Distributors sourcing alternative Acetaminophen; Oxycodone products should verify trading partners' FDA registration status and enforcement history.

Practical Compliance Actions:

• Verify trading partner registrations: Use the ColdChainCheck directory to confirm that alternative product suppliers hold active FDA establishment registrations and state wholesale drug distributor licenses in relevant jurisdictions. Filter by state to identify licensed entities.

• Check enforcement history: Review whether potential substitute suppliers have FDA warning letters, recalls, or state board actions related to controlled substance handling. Entities with clean records reduce supply chain risk during product transitions.

• Document due diligence: DSCSA requires wholesale distributors to verify trading partner legitimacy before transacting. Discontinuation-driven product switches trigger this verification obligation. ColdChainCheck compliance scores provide a standardized starting point for vendor qualification documentation.

• Monitor state-specific requirements: Some state boards of pharmacy impose additional reporting when a distributor discontinues a controlled substance product line. Check jurisdiction-specific guidance through state board links in entity profiles.

ColdChainCheck tracks FDA establishment registrations, state licenses, NABP accreditation status, and enforcement actions across all entities. For ongoing coverage of drug shortage impacts and wholesale distributor compliance requirements, see the compliance guides section.

Disclaimer: This article provides informational content based on publicly available FDA data as of January 15, 2025. It is not legal or regulatory advice. Wholesale drug distributors should consult legal counsel and verify current requirements with FDA, DEA, and relevant state boards of pharmacy.