311830_0The biotech and pharmaceutical industries face new changes with proposed rules concerning cGMP (current good manufacturing practice) for combination products. The cGMP proposal (74 Fed. Reg. 48,423) by the FDA’s Office of Combination Products (OCP) won’t create brand-new requirements. However, this proposed rule clarifies confusion applied to devices, drugs and biological products that are used to create combination products. Pharmaceutical consulting firms state that 300 manufacturers will be affected by this new regulation proposal.

What Defines a Combination Product?

A combination product is a product combined with two or more FDA components. FDA regulates drugs and devices under FDCA (Federal Food, Drug, and Cosmetic Act). Biological products are placed under section 351 of PHS Act (Public Health Service Act). HCT/Ps are found under section 361 of the PHS Act.

These FDA regulated components include the following:
•    Drugs
•    Biologics (i.e. blood/blood components)
•    Medical devices
•    Human cell or tissue products (also known as “HCT/Ps”)

Combination products are described as:
•    Physically combined during manufacturing – creates single entities or two separate component in the same package – also known as “co-packaging”
•    Cross labeled – Components are manufactured separately and packaged (but labeled specifically for use with another product)

Clarification of cGMP Requirements

According to the FDA, each product has separate cGMP regulations. When products are combined together, confusion occurs as to which regulations apply to products when they are combined.

These new OCP regulations concerning combination products would clarify the following issues:

•    Reduce confusion regarding cGMP requirements applied to combination products
•    Ensure consistency with applications and enforce necessary requirements

The biggest issue with combination products is when constituents are combined in co-packaging or single entities. Overall, these revised regulations streamline options – avoids establishing duplicate drug and device quality systems.

The FDA reports that compliance with these cGMP regulations would not add extra burdens on manufacturers, and would actually reduce the paperwork hassle associated with co-packaged and single-entity combination products.

In 2004, the OCP issued draft guidance but never finalized it. Instead of finalizing the original draft guidance, the OCP decided to write new regulations that are similar to the proposed draft guidance.

The FDA plans to follow necessary administrative processes. They will finalize comments by the end of December 2009, and make these new regulations effective 180 days from its publication date.  These new rules will ease the confusing issues that both the pharmaceutical and biotech industries have concerning combination products.

Sample Sections of Proposed Regulations

•    Sec 4.3. – Identifies drug cGMP regulations which applies to drug constituents of combination products. (i.e. QSR for devices). It also applies cGMP regulations of constituent parts for combination products created by cross labeling.

•    Sec 4.4. – FDA states that constituent parts of combination products retain regulatory stats (drugs or devices), even after parts are combined. Also, cGMP requirements continue to apply to each constituent part – whether they are in a co-packaged product or physically combined in single entities. The manufacturer adheres to cGMPs for drug constituents and QSR for device constituents.

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