Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices, and/or medicated cosmetics must register with the Department of Health unless otherwise noted as a designated exemption.
Regulations/Statutes
- Pennsylvania Controlled Substance, Drug, Device and Cosmetic Act
- Pennsylvania Controlled Substance, Drug, Device and Cosmetic Regulations
- Pennsylvania Non-Controlled Substances (List I) Registration and Reporting Act
- Generic Drug Substitution/Equivalency Overview of Laws/Regulations
- Pennsylvania State Board of Pharmacy
- Narrow Therapeutic Index General Information
- Federal Requirements for Electronic Orders and Prescriptions
- Pennsylvania Wholesale Prescription Drug Distributors License Act
National Precursor Log Exchange (NPLEx) Information and Resources
- NPLEx – National Precursor Log Exchange
- House Bill 602 Act 53 of 2013
- PA NPLEx Registration Instructions
- Letter of Notification for Act 53 of 2013
Contact Us
Pennsylvania Department of Health
Attn: Drug & Device Program
2525 North 7th Street
Suite 210D
Harrisburg, PA 17110
Phone: (717) 787-4779
Fax: (717) 231-4790
Send email correspondence to: ra-ddc@pa.gov
Harrisburg, PA 17110
Phone: (717) 787-4779
Fax: (717) 231-4790
Send email correspondence to: ra-ddc@pa.gov