Office of Acquisition and Logistics — Federal Supply Schedule Service — Pharmaceuticals
Public Law 102-585, Veterans Health Care Act of 1992
The attached documents represent 1) "Dear Manufacturer" letters sent to contractors that have signed Master and Pharmaceutical Pricing Agreements with VA, pursuant to 38 U.S.C. 8126 (P.L. 102-585, Sec. 603); 2) Letters issued by the VA Office of General Counsel; and 3) Annual report filing instructions from the VA Pharmacy Benefit Management (PBM) Group. The documents deal with various scenarios that have arisen over the years in the administration of the statute, and they contain VA's interpretation of the statute as applied to these situations. The documents have been sent in hard copy form to all "covered drug" manufacturers during the annual Federal ceiling price recalculation periods. However, they they have been issued only in years when there were significant questions of general application that required written resolution. These letters will provide valuable guidance and information. If you have any questions about the policies expressed in the letters, please contact Mr. Mel Noel, Contract Staff Attorney, VA Office of General Counsel, 708-786-5167 or mel.noel@va.gov.
Correspondence may be downloaded in Adobe Acrobat (.pdf) format below.
| Correspondence | File Size |
| Dear Manufacturer of Covered Drugs 10/2009 | 426 kb |
| Dear Manufacturer of Covered Drugs 10/2008 | 114 kb |
| Dear Manufacturer of Covered Drugs 10/2007 | 62 kb |
| Dear Manufacturer of Covered Drugs 10/2006 | 62 kb |
| Dear Manufacturer FAMP Concerns 10/2004 | 77.1 kb |
| Dear Manufacturer of Covered Drugs letter 10/2004 | 33 kb |
| Dear Manufacturer of Covered Drugs 07/2004 | 32.1 kb |
| Office of General Counsel Letter 03/2004 regarding calculation of FCPs for Flu Vaccines |
160 kb |
| Public Law Correspondence Index | 96 kb |
| Annual Guidance 10/2002 | 49 kb |
| Dear Manufacturer Letter 10/2001 regarding who is a manufacturer under a licensing agreement, determination regarding certain purchases by INS, exclusion of sales to § 602 entities at less than the statutory price through their PPV's, and calculation of new covered drug pricing |
171 kb |
| Annual Guidance 10/2001 | 198 kb |
| Annual Guidance 10/2000 | 205 kb |
| Annual Guidance 10/1999 | 481 kb |
| Dear Manufacturer Cover Letter 10/1999 regarding all previous correspondence |
83 kb |
| Annual Guidance 10/1998 | 533 kb |
| Office of General Counsel Letter 05/1998 regarding calculation of FCPs for Flu Vaccines |
99 kb |
| Response to Pharmacia Letter 11/1997 | 131 kb |
| Letter from Pharmacia and Upjohn 10/1997 regarding private label packaging |
131 kb |
| Annual Guidance 10/1997 | 178 kb |
| Dear Manufacturer Letter 10/1997 regarding record retention, 2-step computation, transferring covered drugs from one manufacturer to another, and custom or private label packaging |
198 kb |
| Dear Manufacturer Letter 02/1997 regarding penny prices for single schedule companies |
93 kb |
| Annual Guidance 10/1996 |
178 kb |
| Supplementary Guidance 10/1996 regarding nominal prices, drug samples and TRICARE |
149 kb |
| Annual Guidance 09/1995 | 159 kb |
| Dear Manufacturer Letter 09/1995 conveying common errors observed by the Office of the Inspector General in the computation of the FCPs |
169 kb |
| Annual Guidance 09/1994 | 192 kb |
| Dear I.V. Solutions Manufacturer Letter 10/1993 regarding covered drug status of certain I.V. Solutions |
52 kb |
| Annual Guidance 10/1993 | 210 kb |
| Addition of New Covered Drugs 09/1993 | 139 kb |
| Office of General Counsel Letter 07/1993 regarding delegation of Hearing Responsibility, Title VI, P.L. 102-585, Drug Pricing Agreement |
128 kb |
| Dear Manufacturer Letter 06/1993 regarding sales from "any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico" |
57 kb |
| Office of General Counsel Letter 05/1993 Dear Manufacturer Letter 10/1997 regarding transfer of covered drugs |
79 kb |
| Dear Manufacturer Letter 05/1993 regarding technical amendment to the P.L. (dual pricing) |
234 kb |
| Dear
Member of the I.V. Solutions Industry Letter 04/1993 regarding the covered status of I.V. Solutions |
93 kb |
| Dear
Radiopharmaceutical Industry Member Letter 04/1993 regarding agreement between the Department and the manufacturer that Radiopharmacies will not be considered wholesalers |
80 kb |
| Assistant General Counsel Letter 03/1993 to the Deputy Assistant Secretary for Acquisition and Materiel Management regarding Impact of Public Law 102-585 on FSS Contract Pricing |
200 kb |
| Dear Manufacturer Letter 02/1993 regarding request for increase to the FCP |
137 kb |
| Dear Radiopharmacy Operator Letter 02/1993 regarding whether Radiopharmacies need to enter into Master Agreements |
80 kb |
| Dear Manufacturer Letter 12/1992 regarding request for increase to the FCP |
88 kb |
| Annual Guidance 11/1992 | 85 kb |
| Correspondence Archive | 4866 kb |
