| The biotech and pharmaceutical industries face new | | | | Components are manufactured separately and |
| changes with proposed rules concerning cGMP | | | | packaged (but labeled specifically for use with |
| (current good manufacturing practice) for combination | | | | another product) |
| products. The cGMP proposal (74 Fed. Reg. 48,423) | | | | Clarification of cGMP Requirements |
| by the FDA's Office of Combination Products (OCP) | | | | According to the FDA, each product has separate |
| won't create brand-new requirements. However, this | | | | cGMP regulations. When products are combined |
| proposed rule clarifies confusion applied to devices, | | | | together, confusion occurs as to which regulations |
| drugs and biological products that are used to create | | | | apply to products when they are combined. These |
| combination products (CP). Pharmaceutical consulting | | | | new OCP regulations concerning combination products |
| firms state that 300 manufacturers will be affected | | | | would clarify the following issues:o Reduce confusion |
| by this new regulation proposal. | | | | regarding cGMP requirements applied to combination |
| What Defines a Combination Product? | | | | productso Ensure consistency with applications and |
| A CP is a product combined with two or more FDA | | | | enforce necessary requirements |
| components. FDA regulates drugs and devices under | | | | The biggest issue with CP is when constituents are |
| FDCA (Federal Food, Drug, and Cosmetic Act). | | | | combined in co-packaging or single entities. Overall, |
| Biological products are placed under section 351 of | | | | these revised regulations streamline options - avoids |
| PHS Act (Public Health Service Act). HCT/Ps are | | | | establishing duplicate drug and device quality systems. |
| found under section 361 of the PHS Act. | | | | The FDA reports that compliance with these cGMP |
| These FDA regulated components include the | | | | regulations would not add extra burdens on |
| following:o Drugso Biologics (i.e. blood/blood | | | | manufacturers, and would actually reduce the |
| components)o Medical deviceso Human cell or tissue | | | | paperwork hassle associated with co-packaged and |
| products (also known as "HCT/Ps") | | | | single-entity CPs. |
| Combination products are described as:o Physically | | | | In 2004, the OCP issued draft guidance but never |
| combined during manufacturing - reates single entities | | | | finalized it. Instead of finalizing the original draft |
| or two separate component in the same package - | | | | guidance, the OCP decided to write new regulations |
| also known as "co-packaging"o Cross labeled - | | | | that are similar to the proposed draft guidance. |