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CHRONOLOGY OF EVENTS CONCERNING DRB'S POSITION ON ANTISUBSTITUTION LAWS

11 July 1973 Joint meeting of PMA and DRB representatives. At this meeting it was suggested that the DRB might help defend existing drug anti-substitution laws.

30 November 1973 - Joint meeting of PMA and DRB. At this meeting Drs. Kinney and Pittman proposed the original resolution completely endorsing existing antisubstitution laws.

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25 March 1974 - Regular meeting of the DRB. At this meeting the proposed resolution (drafted November 30) was disputed by Dr. Penna and tabled, pending further consideration in a joint meeting of representatives from APhA and DRB.

21 June 1974 Joint meeting of APhA and DRB. At this meeting Drs. Hussey and Pittman learned more about the position of the APhA on the question of antisubstitution laws and were impressed by the data presented concerning brand names and their relation to drug products. A markedly revised resolution for consideration by DRB was then prepared by Drs. Pittman and Hussey following this meeting.

26 September 1974 - Joint meeting of DRB-PMA-APhA. At this meeting a draft was written, distributed, and reworked to attempt to find the most reasonable position for the DRB to take with regard to drug antisubstitution laws.

25 October 1974 - Regular meeting of the DRB. The resolution emanating from the foregoing meetings was further reworked, the wording and phrasing changed to make it more substantial and explicit, then it was passed by all 13 of the 14 members present, Dr. Crout abstaining because of his position in the government and Dr. Calabresi, Drill, Hodges, and Papper being absent.

28 October 1974, and thereafter - Various interpretations of the resolution, some without giving the resolution itself, appeared in various news media and journals. 19 November 1974 - DRB's resolution was approved by NAS/NRC Assembly of Life Sciences and limited distribution was begun.

21 November 1974 - Mr. Trexler sent a memorandum to all DRB members notifying them of ALS action and sending them copies of the resolution.

20 December 1974 - Mr. Trexler sent a memorandum to members of DRB announcing approval of the resolution by Assembly of Life Sciences and stating that a press release on it may be made soon.

21 January 1975 - NAS/NRC press release was made and was given wide distribution, entitled "Drug Board Urges Change in Drug Substitution Laws."

26 February 1975 - Regular meeting of Committee on Problems of Drug Safety. Resolution was discussed under heading "The Anti-Substitution Resolution of the Drug Research Board."

14 March 1975 - Regular meeting of DRB. Despite prior assurances that the matter of the resolution had been concluded and that no substantive new information relevant to it had been presented for discussion, a concerted effort to obtain repeal or major modification of the resolution was made. The press release of 21 January was criticized, and a "clarifying statement" was drafted and approved. In addition, an attempt was made to prepare a draft of another proposed press release to publicize the "clarifying statement."

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Ipsatol DM

Ipecac, Ammonium Chloride Davies Rose Hoyt Tolu Balsam

Ipecac, Ammonium Chloride Davies Rose Hoyt Tolu Balsam and

Dextromethorphan

Lakeside

Lakeside

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Vi-Synecal

Acidophiluş

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Oxyphenbutazone

Desipramine

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Mono and dibasic

potassium phosphate

Digitalis

Imipramine

Quinidine Sulfate

Chlorthalidone and reserpine

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Diethylpropion HCI

National

Trimethcbenzamide HCI

Roche

Racepin HCI

USV

Isoproterenal Sulfate

USV

Multivit & min

USV

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These products were acquired by either Ciba-Geigy or USV in a non-exclusive agreement by which the products will be available under different trade names from both manufacturers. The older trade name is listed in parentheses.

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