The Museums
FDA GRANDFATHER
Clause Petition
VARIOUS FDA GRANDFATHERED CONTROLLED SUBSTANCES

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:
"I need to know if any of the following controlled substances were originally given or had FDA grandfather clause approval in or around 1970, when the Controlled Substances Act took effect:
  -   Codeine
  -   Opium
  -   Morphine
  -   cocaine
According to various pharmaceutical catalogs, the following drugs were on sale on Jan 1938:
  -   Codeine Alkaloid
  -   Codeine phosphate
  -   Codeine Sulfate
  -   Morphine Sulfate
  -   Morphine Alkaloid
  -   Cocaine Alkaloid USP
  -   Cocaine Hydrochloride
  -   Opium
And thus I must assume that they were grandfathered in.   However, for technical reasons, I need to know if they indeed were.   Specifically, if they were FDA approved via the grandfather clause. . . [more] . . ."

Andrew Garret
Museum Curator
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.

WARNING:   Although every effort has been taken to present technically accurate information ; Still, as no one over here has any medical training, some very minor technical errors or miscommunications could have slipped in.   However the petitioners are of the believe that ALL information presented here is technically correct.


OPIUM & BELODONA

Opium
[Belladonna-Opium*]
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).

Opium
[Belladonna-Opium*]
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]
Subject: Belladonna and Opium Suppositories
Date: September 30, 2009
Cc: [Name(s) withheld]

Dear Mr. Garret,
Thank you for contacting Paddock Laboratories.   Our Belladonna and Opium Suppositories are grandfathered products; they have not been evaluated by the FDA.   We only have pictures on the box or the finished suppositories in the plastic mold (similar to what you've found on the Internet).   Please explain the purpose of the petition again.

Best regards,
[Name withheld]
Professional Affairs Manager
[*]- 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


Cocain
[Cocaine Hydrochloride*]
Grandfather Drug - Note the "C" on the Label


Cocain
[Very Old Cocaine Ad - Note Roxane = Boehringer]


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

codeinesulfate
[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
Date: 5 Mar 2007
From: [name withheld]

Mr. Garrett,
Reference is made to your request for information regarding our Codeine Sulfate Tablets, USP.

Our Codeine Sulfate Tablets USP are considered a "grandfathered" product by the FDA. If you have any additional questions, please call me at (800) . . . . and select option 2.

Kind Regards,
[name withheld]
Technical Product Information
Bochringer Ingelheim Roxane, Inc.
[More contact info]
[*]- 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.

Robins
[Robitussin AC]
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]
Date: 7, Mar 2007
From: "ProdInfo" [name withheld] @kingpharm.com

We have consulted our regulatory affairs department and were informed that nucofed(R) products were "Grandfathered" in as far as FDA approval.

MONARCH
Bristol, Tn

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 Drugs
Date: 6 Mar 2007
From: [name withheld]

Andrew,
Acetaminophen & Codeine Phosphate Oral Solution USP and Promethazine HCl & Codeine Phosphate Syrup are FDA approved drugs.   Pharmaceutical Associates, Inc. currently holds ANDA approval for these two products.

Guaifenesin with Codeine Phosphate is a grandfathered drug.

If you go to this website, http://www.fda.gov/cder/ob you will be able to locate all the drugs that the FDA has ever approved.

Hope this info helps.
[name withheld]
Customer Service Manager
Pharmaceutical Associates, Inc.
1700 Perimeter Road
Greenville, SC 29605
[More contact information]
Website: www.paipharma.com
Due 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:

Tusso Tussi Cough

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.
Subject: Re: morphine inquiry
From: [name withheld]@baxter.com
Date: 8 Mar 2007

Mr. Garret,
Thank you for your quick response.   I was hoping we could speak so I could explain the situation in detail but I will do my best with this method of communication.

The FDA has website where this information can be accessed by anyone.   It is open to the public at no charge should you have other drugs you would also like to investigate.   The URL is http://www.fda.gov/cder/ob/default.htm.   It is the Electronic Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations.   Per the Orange Book, Duramorph PF has an approval date of 091884. Infumorph has an approval date of 071991.   The morphine sulfate dosette manufactured by Baxter Healthcare Corporation does not have a rating listed in the orange book because of the "grandfather" clause.   If you would like to request verification from the FDA, the address for inquiries is Druginfo@CDER.FDA.GOV.

Wyeth would have to provide any information about the discontinued morphine sulfate tubex product.   I hope this information has been helpful.

[name withheld], RN
Clinical Affairs Manager
Clinical Affairs/Medication Delivery
[more contact info] . . . @baxter.com
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 Site
Date: 26 Sep 2006
From: "CDER DRUG INFO"

Dear Andrew,
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The FDA does not have such specific information.   You may obtain a copy of a text called the USP DI Volume III approved Drug Products and Legal Requirements, where there is a list of grandfathered drugs.   This text book is often in most community pharmacies.   Or you may contact the U.S. Pharmacopeia at 800-822-8772 for more information on obtaining of list of grandfathered drugs.

Then you can see which of those were made from controlled substances.

Best regards,
Drug Information CC
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute and advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
NOTE: 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.  
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