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Pharmacy Affairs & 340B Drug Pricing Program

 

Federal Register Notices

The following Federal Register notices, listed in chronological order, contain guidelines for participation in the 340B Program or have relevance to the 340B Program:

May 7, 1993 (Vol. 58, No. 87, pp. 27289-27293) Guidance Regarding Section 602 of the Veterans Health Care Act of 1992 Limitation on Prices of Drugs Purchased by Covered Entities (Introduction, Covered Entities, Covered Drugs, Calculation of the Drug Price, Manufacturers' Information, Covered Entities' Information, Confidentiality Provisions). 

May 7, 1993 (Vol. 58, No. 87, pp. 27293-27294) Notice Regarding Section 602 of the Veterans Health Care Act of 1992, Duplicate Discounts and Rebates on Drug Purchases (All-Inclusive Rates Per Encounter or Visit, Drug Purchases Not Reimbursed Under All-Inclusive Rate). 

June 23, 1993 (Vol. 58, No. 119, pp. 34058-34059) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Duplicate Discounts and Rebates on Drug Purchases

December 29, 1993 (Vol. 58, No. 248, pp. 68922-68925) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines (Confidential Drug Pricing Information, Duplicate Discount/Rebate Potentital, Eligibility for Retroactive Discounts, Entity Guidelines Regarding Drug Diversion, Audit Requirements, Entity Participation, Group Purchasing, Purchasing Agents, Definition of Covered Outpatient Drug, Dealing Direct or Through a Wholesaler, Manufacturer's Contracts Requiring Entity Compliance).

May 13, 1994 (Vol. 59, No. 92, pp. 25110-25114) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines (Confidential Drug Pricing Information, Duplicate Discount/Rebate Potential, Eligibility for Retroactive Discounts, Entity Guidelines Regarding Drug Diversion, Audit Requirement, Entity Participation, Group Purchasing, Purchasing Agents, Definition of Covered Outpatient Drug, Dealing Direct or Through a Wholesaler, Manufacturer's Contracts Requiring Entity Compliance). 

June 6, 1994 (Vol. 59, No. 107, pp. 29300-29301) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Inclusion of Outpatient Hospital Facilities

June 10, 1994 (Vol. 59, No. 111, pp. 30021-30024) Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Manufacturer Audit Guidelines and Informal Dispute Resolution

September 19, 1994 (Vol. 59, No. 180, pp. 47884-47886) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Outpatient Hospital Facilities

May 26, 1995 (Vol. 60, No. 102, pp. 27983-27984) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing

August 3, 1995 (Vol. 60, No. 149, pp. 39762-39764) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (Covered Entity Status, Entity Participation Requirements, Definition of Eligible Entity "Patient"). 

October 2, 1995 (Vol. 60, No. 190, pp. 51488-51489) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing

November 1, 1995 (Vol. 60, No. 211, pp. 55586-55587) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Contracted Pharmacy Services

August 23, 1996 (Vol. 61, No. 165, pp. 43549-43556) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Guidelines Regarding Contract Pharmacy Services (Revised Final Mechanism, Certification, Anti-kickback Statute, Suggested Contract Provisions). 

October 24, 1996 (Vol. 61, No. 207, pp. 55156-55158) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (Definition of a Patient). 

December 12, 1996 (Vol. 61, No. 240, pp. 65406-65413) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Manufacturer Audit Guidelines and Dispute Resolution Process 0905-ZA-19

August 29, 1997 (Vol. 62, No. 168, pp. 45823-45824) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Rebate Option (State ADAP Section 340B Rebate Option). 

June 29, 1998 Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 -- Rebate Option (State ADAP Section 340B Rebate Option). 

October 22, 1998 (Vol. 63, No. 204, pp. 56656-56658) Notice Regarding HRSA Grant Requirement -- Participation in the 340B Drug Pricing Program

February 9, 2000 (Vol. 65, No. 27, pg. 6383) Notice Regarding HRSA Grant Requirement -- Participation in the 340B Drug Pricing Program

March 15, 2000 (Vol. 65, No. 51, pp. 13983-13984) Notice Regarding the Section 340B Drug Pricing Program -- Program Guidance Clarification (Duplicate Discounts). 

September 21, 2004 (Vol. 69, No. 182, pp. 56433-56445) Statement of Organization, Functions and Delegations of Authority

January 12, 2007 (Vol. 72, No. 8, pp. 1540-1543) Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services

January 12, 2007 (Vol. 72, No.8, pp 1543-1546) Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition of "Patient"

July 9, 2007 (Vol. 72. No. 130, pp 37250-37252) Notice Regarding the 340B Drug Pricing Program; Children's Hospitals