South Carolina Requires a New License for Contract Manufacturers

The South Carolina Board of Pharmacy has introduced a new Non-Resident Contract Manufacturer Permit, and CMOs whose products enter into the state need to take action.

The Board has posted the permit application on its website, and the requirement is already in effect. For any entity that manufactures a finished drug or device according to another party's specifications, including packaging, repackaging, labeling, or relabeling, a separate permit is now required if those products are entering the state of South Carolina.

What Changed and Why It Matters

This requirement has been in the works since mid-2025. At its June 18, 2025 meeting, the South Carolina Board of Pharmacy unanimously approved a motion requiring all contract manufacturers, both domestic and foreign, to obtain a separate license from the Board. Following a full public rulemaking process, the final regulation was published and became effective on May 22, 2026. The adopted rule can be reviewed in the South Carolina State Register, Vol. 50, Issue 5.

South Carolina Code of Regulations Section 99-43 requires a separate permit for each business practice a facility engages in. That means a single Non-Resident Manufacturer/Repackager permit is no longer sufficient for facilities operating across multiple entity types.

The Board now distinguishes between three separate categories:

• Manufacturer, which includes packaging, repackaging, labeling, and relabeling
• Virtual manufacturer
• Contract manufacturer

If your facility operates as a contract manufacturer and is distributing product into South Carolina, a standalone Non-Resident Contract Manufacturer/Repackager Permit is required.

What Currently Licensed Manufacturers Should Know

The South Carolina Board of Pharmacy has informed LighthouseAI that it will be reaching out to currently licensed nonresident manufacturers within the next week with instructions for updating the license to the correct category.

If you hold a nonresident manufacturer license in South Carolina, watch for that communication and act on it promptly.

The resident CMO license is also expected to be posted to the Board's website shortly.

This Applies to International CMOs as Well

A member of the South Carolina Board of Pharmacy confirmed to LighthouseAI that this requirement applies to both domestic and international CMOs. For manufacturers and virtual manufacturers partnering with international contract manufacturers, this is an important consideration.

If those partners are shipping finished product into South Carolina, they will need to obtain this permit. Companies working with international CMOs should factor this into their compliance planning now.

For a deeper look at the regulatory requirements that come with partnering with international manufacturers, see our recently published article: Utilizing Foreign CMOs and Hidden Federal and State Regulatory Requirements.

What Manufacturers and Virtual Manufacturers Should Do

If you partner with a CMO that distributes into South Carolina, this requirement affects you too. A CMO that is not properly licensed in South Carolina creates a compliance gap that can disrupt your ability to distribute product into the state. Now is the time to confirm that your contract manufacturing partners are aware of this requirement and are taking steps to come into compliance.

What to Do Next

CMOs manufacturing products that end up in South Carolina should begin the licensing application process immediately. Applications are available on the South Carolina Board of Pharmacy website at llr.sc.gov/bop/apply.aspx.

The Board has indicated that more information is forthcoming. Keep an eye on the South Carolina Board of Pharmacy website and subscribe to the LighthouseAI Newsletter to stay ahead of any updates as they are released.

Stay Compliant With LighthouseAI

Regulatory requirements across the pharmaceutical and medical device supply chain change constantly, and South Carolina is just one example of how quickly new obligations can emerge.

LighthouseAI provides professional state licensing support to help manufacturers, virtual manufacturers, CMOs, and their partners stay compliant across all 56 US jurisdictions. Our regulatory monitoring software delivers real-time notifications on new and changing licensing requirements so your team is never caught off guard.

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