here's the latest consumer protection saga. i'll mostly be including emails and letters i have sent in the last 24 hours, since they speak for themselves. the super quick summary is this: i bought some over the counter antifungal medication from a (Waysafe) store that was expired. now, since this seemed to be to be highly sketchy, i was somewhat miffed. and unfortunately, i bought it in Colorado, but here in SunnySouthernCalifornia, we don't have Waysafe stores (we have their sister store, Novs, but i didn't feel like hassling with them, trying to get them to take a return just because they are owned by the same holding company.)

so, i decided to see what i could get the PTB (Powers That Be) to do about it: or at least to see if they care. i mean, isn't that the eseence of consumer protection?

results thus far: they don't care. yet.

Email 1: (really, it was a web page comment submission), to the FDA (which i have a distinct sense might have been more helpful before the a certain fascist corporate administration took office a little under four years ago...)

Comments: I write to enquire what regulation is done regarding retailers selling OTC drugs which are past their expiration date. (I purchased a container of DrugBrandname AF on September 26, 2004, at a Waysafe store, which I later realized was labelled with an expiration date of July 2004.)

I have searched through the FDA website, but have been unable to find specifically what I should do about this, and if/how it should be reported.

Thank you for your assistance.

here is the pitiful response this garnered:

From: "CDER DRUGINFO"
To: "'myemail@yahoo.com'"
Subject: RE: DrugInfo Comment Form FDA/CDER Site
Date: Wed, 27 Oct 2004 11:25:56

Thank you for your message to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).

The FDA regulates manufacturers, not pharmacies or retailers that sell drugs. This store should not have sold you an expired medication. You can report this to your State Board of Pharmacy. Here is a link with state contact information: http://www.nabp.net/whoweare/boards3.asp

I hope this information is helpful.

Sincerely,
Drug Information CY

Disclaimer: This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

actually, no: this information was NOT helpful. in fact, it was mostly misleading, and the Disclaimer in their signature was more substantive than the text of the email. nevertheless, being the good crusader for consumer i am, i trudged on, and proceeded to look up the Colorado State Board of Pharmacy. i wrote a similar message to them, with a little more detail:

Hello,

The FDA recommended I write to you with my inquiry. (Their response, from DRUGINFO@cder.fda.gov, is included below.)

On September 26, 2004, I purchased a container of DrugBrandname AF (drug chemical name) from a Waysafe store in Colorado Springs, at 123 Somewhere Street, 809**. It has not been particularly effective despite my using it consistent with the package directions, and I have since noticed that it is labelled with an expiration date of July 2004. I do still have the original packaging, drug container, and receipt.

To be clear, this was an over-the-counter drug, purchased off the shelf from an aisle in the Waysafe, not the pharmacy. However, it seems that the FDA believes it nevertheless falls under your purview.

I couldn't find anything in the Board of Pharmacy regulations which treats this. If it is the case that you do not regulate it, I would appreciate suggestions that you might have as to who would I should contact.

Thank you very much for any assistance you can offer.

Sincerely,

and received this almost-as-unhelpful response:

Mr. (me)

Since the product is OTC, the Colorado State Board of Pharmacy does not regulate it. You may wish to contact the Consumer Protection Division at the Colorado Department of Public Health and Environment. Their phone number is 303-***-****.

(signed, Jane Doe)

The Colorado State Board of Pharmacy
1560 Broadway, Ste. 1310
Denver, CO 80202-5146
303-***-****
jane.doe@dora.state.co.us

so i contacted the Consumer Protection Division at the Colorado Department of Public Health and Environment (CDPHE). and i was getting a little tired of the run-around, so i decided to go legal on their ass:

27 October 2004

To: Colorado Department of Public Health and Environment (CDPHE)
Consumer Protection Division

To whom it may concern:

I write to you with a consumer protection complaint, regarding the holding and sale of over the counter (OTC) medications in retail stores. If this complaint/request for assistance must be submitted in writing, and/or directly to the Attorney General's Consumer Protection division, please so advise me, and I will be happy to do so.

On September 26, 2004, I purchased a container of DrugBrandname AF (drug chemical name), an over the counter (OTC) medication, from a Waysafe store in Colorado Springs: 123 Somewhere Street, Colorado Springs, Colorado 809**. I have since noticed that it is labeled with an expiration date of July 2004. I do still have the original packaging, drug container, and receipt, and would be happy to provide photocopies of these things if you desire them.

I hope that you will pardon me for the extensive legal language that appears below; in pursuing this issue, I have been bounced from the FDA, to the Colorado Board of Pharmacy, to the CDPHE. As a result, I thought I would provide my research on the topic, in an attempt to assist in resolution of my complaint/request for assistance.

It seems to be that Safeway's holding for sale of expired medications violates C.R.S. sec. 25-5-403, the Pure Food and Drug Law:

25-5-403(1) The following acts and the causing thereof within this state are prohibited:
(a) The manufacture, sale, or delivery or the HOLDING or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded... (emphasis added)

I believe this product to be "adulterated" within the meaning of the Pure Food and Drug Act, specifically C.R.S. sec. 25-5-414(1)(c):

(c) If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or HOLDING do not conform to or are not operated or administered in conformity with current good manufacturing practice ... (emphasis added)

"current good manufacturing practice", as defined in the Code of Federal Regulations, regulating the U.S. Food and Drug Administration, specifies that "current good manufacturing practice" for finished pharmaceuticals includes expiration dating. (See 21 C.F.R. sec. 211.137). Thus, ipso facto, products beyond their expiration dates should not be sold to the public.

I am writing to you because authority for enforcement of the Pure Food and Drug Act is vested in the Department of Public Health and Environment, per C.R.S. sec. 25-5-420.

Thank you very much for any assistance you can offer. Please feel free to contact me by email, telephone, or letter.

Sincerely,
my*name*********

+++++++++++++++++++++++++++++++++++
my*name*********, Attorney at Law
(***)...-.... * myemail@yahoo.com
1234 My Street
Sunny City, CA 99999
Member of the Bar:
Colorado Supreme Court
U.S. District Court, Colorado
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
This electronic mail message may be protected by attorney-client
privilege, or other legal privileges. If you are not the intended
recipient, please inform ***************, Attorney at Law, and
delete the message without copying it. Thank you.
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

no response yet. updates will follow.

good night!