E6-18892. Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; delay of applicability date.

SUMMARY:

The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a “health care entity.” In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments.

As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of § 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

DATES:

The applicability date for § 203.3(q) to the wholesale distribution of blood derivatives by health care entities is delayed until December 1, 2008.

FOR FURTHER INFORMATION CONTACT:

Denise Sánchez, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

The PDMA (Pub. L. 100-293) was enacted on April 22, 1988, and was modified by the PDA (Pub. L. 102-353, 106 Stat. 941) on August 26, 1992. The PDMA, as modified, amended the Federal Food, Drug, and Cosmetic Act (the act) to, among other things, prohibit, with certain exceptions, the sale, purchase, or trade (or offer to sell, purchase, or trade) of prescription drugs that were purchased by hospitals or other health care entities (section 503(c)(3)(A)(ii)(I) of the act (21 U.S.C. 353(c)(3)(A)(ii)(I))). Section 503(c)(3) of the act also states that “[f]or purposes of this paragraph, the term ‘entity’ does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law * * *.”

On December 3, 1999, the agency published final regulations in part 203 (21 CFR part 203) implementing PDMA (64 FR 67720) that were to take effect on December 4, 2000. Most of the provisions of the final rule took effect on this date. Certain provisions of the final rule, including § 203.3(q) which defines the term “health care entity,” were delayed on account of concerns raised by the affected parties. The agency received several letters on, and held several meetings to discuss, the implications of the final rule for blood centers that distribute blood derivative products and provide health care to hospitals and patients. Under the final rule as written, blood establishments functioning as health care entities would not be allowed to engage in wholesale distribution of prescription drugs except for blood and blood components intended for transfusion, which are exempted from the regulations under § 203.1. As discussed in the preamble to the final rule (64 FR 67720 at 67725 to 67727), blood derivatives are not blood components. Therefore, under the final rule as written, registered blood establishments that qualify as health care entities could not distribute blood derivatives. Based on comments from interested parties, FDA decided to delay the applicability of § 203.3(q), until October 1, 2001, and reopened the administrative record to give interested persons until July 3, 2000, to submit written comments on this provision (65 FR 25639, May 3, 2000).

FDA has delayed the applicability date of § 203.3(q) four more times, most recently until December 1, 2006. On these occasions, the applicability date was delayed to give the agency time to consider whether regulatory changes were warranted (66 FR 12850, March 1, 2001; 67 FR 6645, February 13, 2002; 68 FR 4912, January 31, 2003; 69 FR 8105, February 23, 2004). In the Federal Register of February 1, 2006 (71 FR 5200), FDA issued a proposed rule that would amend the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. FDA has received substantive comments on the proposed rule from affected parties. Today, FDA is further delaying the applicability of § 203.3(q) to the wholesale distribution of blood derivatives by health care entities to give FDA additional time to address comments on the proposed rule and consider the appropriate regulatory changes.

FDA has examined the impacts of this delay of the applicability date under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this action is consistent with the regulatory philosophy and principles identified in the Executive order. This action will ease the burden on industry by delaying the applicability of § 203.3(q) to the wholesale distribution of blood derivatives by health care entities while FDA continues to address comments on the proposed rule and consider regulatory changes. Thus, this action is not a significant action as defined by the Executive order.

To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, the agency's implementation of this action without opportunity for public comment, effective immediately upon publication today in the Federal Register, is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Seeking public comment is impracticable, unnecessary, and contrary to the public interest. Given the imminence of the current December 1, 2006, compliance date, seeking prior public comment on this delay is contrary to the public interest in the orderly issuance and implementation of regulations.

This action is being taken under FDA's authority under 21 CFR 10.35(a). The Commissioner of Food and Drugs finds that this delay of the applicability date is in the public interest.

Dated: October 31, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.