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The purpose of this section is simply to prove/establish that there are numerous FDA Grandfathered-control substances [note the "C" on the given labels]. Thus one must ask the question; "Why should Medical Cannabis be treated any differently?" According the FDA original rejection letter: “FDA notes that marihuana is currently listed in Schedule 1 under the Controlled Substances Act (21 U.S.C. 812(c). 21 CFR 1308.11(d)(19). The labeling for all Schedule 1 drugs is required to bear the “C-1” symbol (21 CFR 1302.03). FDA would regard the inclusion of the ”C-1” symbol on a product as a labeling change regarding the conditions of its use. This would be true even if marihuana were rescheduled and placed in Schedules 2 through 5: the inclusion of the “C” symbol on the product would be viewed as a labeling change regarding the conditions of its use.“ [Dennis E. Baker - Associate Commissioner for Regulatory Affairs] The following is a Generic Letter (very similar to one) sent out to various present-day pharmaceutical manufacturers. Subject: Request for Assistance:The following are selected responses received from various pharmaceutical manufacturers of these products. Note due to various confidential disclaimers [those things that look as follows]: "DISCLAIMER: The information transmitted is intended only for the person(s) or entity to which it is addressed and may contain confidential and/or legally privileged material. Delivery of this message to any person other than the intended recipient(s) is not intended in any way to waive privilege or confidentiality. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by entities other than the intended recipient is prohibited. If you receive this in error, please contact the sender and delete the material from any computer."Only bits and pieces of those e-mails can be shown on this website.
OPIUM & BELODONA Grandfather Drug - Note the "C" on the Label Belladonna alkaloids/opium alkaloids 16.2 mg / 30 mg rectal suppositories B&O Supprettes 15A (NDC 61451-5015-07). Grandfather Drug - Note the "C" on the Label Belladonna alkaloids/opium alkaloids 16.2 mg / 60 mg rectal suppositories B&O Supprettes 16A (NDC 61451-5016-07) PADDOCK LABORATORIES, INC. 3940 QUEBEC AVENUE NORTH MINNEAPOLIS, MINNESOTA 55427 [Product is Grandfathered as per Oral telephone and the following e-mail conversion] From: [Name withheld][*]- Pictures used here are used without permission of the picture takers, if there is a problem, please let us know and we will take them off. COCAINE HYDROCHLORIDE Grandfather Drug - Note the "C" on the Label Cocaine Hydrochloride Topical Solution (Roxane) - is granfathered -- As per an oral Telephone conversation with the manufacturer. Roxane Labs. Columbus, Oh. [*]- Picture here is used without permission of the picture taker, if there is a problem, please let us know and we will take it off. CODEINE SULFATE TABLETS Grandfather Drug - Note the "C" on the Label [Product is Grandfathered as per the following e-mail conversion] Subject: Codeine Sulfate Tablets USP[*]- Picture here is used without permission of the picture taker, if there is a problem, please let us know and we will take it off. CODEINE PHOSPHATE Although CODEINE sounds a lot like Cocaine, it is actually an opium derivate. Because, because of the fact that Codeine Phosphate is used in numerous cough syrups, it would be all but impossible to document ALL the FDA Grandfather clause drugs out in the market today. The following, Robitussin AC is probably the best known of all these Grandfathered Cough Syrups. Grandfather Drug - Note the "C" on the Label Trivia: Robitussin AC as well as Robitussin DAC syrups were taken off the market in 2001, apparently due NOT to their effectiveness, but because of the bad publicity given them by cartoonists. NO joke, just look up Robitussin on the internet, to this day you still see numerous cartoons showing (ah) troubled people chucking the stuff down. However, as can be seen, by all the other “tussins” out there, the only thing that went away was the name. MONARCH - CODEINE PHOSPHATE [Product is Grandfathered as per the following e-mail conversion] [With reference to our inquiries regarding the following drugs containing CODEINE PHOSPHATE ] 1- Nucofed Capsules (Monarch) 2- Nucofed Pediatric Expectorant Syrup (Monarch) Subject: Nucofed(R) capsules [Codeine Phosphate-Pseudoephedrine Hydrochloride] PHARMACEUTICAL ASSOCIATES - CODEINE PHOSPHATE Pharmaceutical Associates Greenville, SC Manufacturers of the following drugs containing CODEINE PHOSPHATE] 1- Acetaminophen and Codeine Phosphate Oral Solution USP 2- Proimthazine Hydrochloride and Codeine 3- Guaifenesin Syrup with Codeine C-5 or CV Grandfather drug over the counter [Product is Grandfathered as per the following e-mail conversion] Subject: FDA Approved DrugsDue to the number of grandfathered cough syrups, it would be impossible to even attempt to list them all. Below are some pictures of products that we think fall into the category of Grandfathered approved control substances. In all cases note the "C" on the label: Pictures are used here without permission of the picture takers. If there is a problem, please let us know and we will take it off. MORPHINE SULFATE WARNING: In terms of FDA standards, Morphine (in general) is sort of a funny drug. Morphine sulfate itself although a grandfathered drug, it received regular FDA approval in the 1980's. So it is sort of both a grandfathered drug as well as a regular FDA approved drug. In either case, it is a control substance. BAXTER Co.Note: The Orange Book is actually a series of FDA publications, which for reasons unknown are collectively known as the Orange Book and can be downloaded as a group via the internet. It consists of various listings of FDA approved drugs, however, no references to FDA grandfathered drugs are made. FDA General correspondence [The following e-mail was received in reply to our inquireries about grandfather clause drugs] Subject: RE: DrugInfo Comment Form FDA/CDER SiteNOTE: We physically looked over the USP DI (vol. 3) and could find NO reference, lists to FDA grandfather clause drugs. THIS DOES NOT mean that such a list is not there, only that the petitioners could not find it; which means that it's probably not there. Additionally, we have contacted the U. S. Pharmacopeia which also has no listing of FDA grandfathered claused drugs. WANT TO KNOW MORE: ===================== Due to space / download time considerations, only selected materials are displayed. If you would like to obtain more information, feel free to contact the museum. All our material is available (at cost) on CD-Rom format. CONTACT PAGE
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