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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 250.500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices

 

BACKGROUND:

Compliance Policy Guide (CPG) Number 7134.01, *(Sec. 230.110)* Registration of Blood Banks and Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products, provides extensive background regarding registration requirements. The purpose of this CPG is to emphasize that plasma brokers are required to register as stated in CPG No. 7134.01 (See Sec 230.110). The agency has not, in the past, focused heavily upon these establishments, however, the number of problem situations involving plasma shipped through brokers has increased. For example, recalls of biological products have occurred in which plasma brokers have been subdistributors. In at least one of these recalls consignees of the suspect products could not be determined due to inadequate or unavailable plasma broker's distribution records.

POLICY:

Plasma brokers that take custody of products are required to register pursuant to 21 CFR Part 607 and must comply with applicable sections of 21 CFR. Sections 606.100 (b)(10) & (18), 606.160 (b)(3)(i) and (iii) and 606.165 are particularly applicable to plasma brokers. Brokers that only handle paperwork and do not take custody of the product are not required to register and, therefore, need only have records showing transfer of the biological product from the manufacturer to the consignee.

REGULATORY ACTION GUIDANCE:

The following represent criteria for direct reference issuance of *Warning* Letters by district offices:

a. The firm is required to register and the establishment file shows that management has been advised of the registration requirement, but has failed to comply. NOTE: The district must contact the *Division of Blood Applications, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER) (HFM-375),* to assure that no registration forms have been received.

or

b. A current inspection of the broker, whether registered or not, shows that the firm has substantive deviations from the area of CGMPRs listed above under "POLICY" such as non-traceability of units in distribution or to original donors; inadequate storage conditions, or any others applicable to the operations in which the firm is engaged.

*Warning* Letters should contain a statement advising the firm that registration is required and include the necessary forms for completion and return to the district within 10 days. Districts should forward completed FD 2830s to *HFM-370* for validation.

If the *Warning* Letter fails to achieve compliance within one week after the response period expires (17 days after issuance), districts should prepare and forward a complaint for injunction [usually a preliminary injunction citing 301(p) of the Federal Food, Drug, and Cosmetic Act] in accordance with Agency procedures.

Deficiencies from standard operation procedures generally would not be a basis for injunction.

If the *Warning* Letter issued cites 501 (a) (2) (B) charges, the district should follow Chapter 8-10 in the Regulatory Procedures Manual.

Copies of all *Warning* Letters issued and responses should be routinely forwarded to the *CBER, Division of Case Management (HFM-610)* and Division of *Compliance Policy (HFC-230)* within 30 days of issuance or receipt.

*Material between asterisks is new or revised*

Issued: 2/1/84
Revised: 3/95