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503B outsourcing facilities permitted in South Carolina must now meet a new Pharmacist-in-Charge (PIC) requirement under updated rules published in the South Carolina State Register on May 22, 2026.
The updated rules amend R.99-43 Facility Permit Classifications by revising the permit requirements for both non-resident and resident outsourcing facilities operating in the state. The updated rules also add section R.99-48 regarding Compounding.
The most notable update is a new Pharmacist-in-Charge (PIC) requirement. South Carolina 503B Outsourcing Facility Permit applicants must now provide the name, title, and active South Carolina pharmacist license number for their designated PIC. The PIC for the non-resident outsourcing facility must also be the PIC in the facility's resident state.
LighthouseAI confirmed directly with the South Carolina Board of Pharmacy that currently licensed outsourcing facilities have until their next renewal deadline, June 30, 2027, to bring their PIC into compliance with this requirement. All new applications must have a South Carolina licensed PIC in place at the time of application.
In addition to the PIC requirement, outsourcing facility permit applicants must now submit written policies and procedures covering a range of operational areas including shipping refrigerated products, temperature and humidity monitoring, quality control and assurance, product recalls, complaint handling, employee training, aseptic process validation, and environmental and personnel monitoring.
Non-resident applicants face additional documentation requirements at both initial application and renewal, including copies of their resident state outsourcing facility permit, DEA registration if applicable, FDA establishment inspection reports including any 483s and responses, and operational inspection reports from the last two years.
The PIC is responsible for notifying the South Carolina Board of Pharmacy within 30 days of any disciplinary action issued by other states or the FDA, any FDA-issued 483s or warning letters and the facility's response, and any recalls issued by the outsourcing facility.
The May 22, 2026 rulemaking also introduced a new Non-Resident Contract Manufacturer Permit requirement in South Carolina. Contract manufacturers distributing finished drug or device products into the state must now hold a separate permit under R.99-43. For more information, see our article: South Carolina Requires a New License for Contract Manufacturers.
The updated rules have been published in the South Carolina State Register, Vol. 50, Issue 5, R.99-43 and R.99-48, May 22, 2026, and will be posted to the South Carolina Board of Pharmacy website shortly. The State Register can be accessed at scstatehouse.gov/state_register.php.
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's Selective Notifications deliver automated regulatory monitoring alerts tailored to your license portfolio, so your team is always informed of new and changing requirements across all 56 US jurisdictions before they affect your operations.
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About the Author
Jennifer Falkenrath is the Director of Regulatory & Legislative Tracking at LighthouseAI. Previous to this role, she was a Bureau Manager with Utah’s Division of Occupational and Professional Licensing, overseeing nine professional licensing Boards, including pharmacy. She has also been a licensed pharmacy technician since 2005.
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