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FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling

A

ariannas

#1
I am having trouble understanding part of the FDA Labeling regulation (21 CFR 801). Specifically, there are two paragraphs that I have read several times, but as far as I can tell, they say the same things with different words.

My usual strategy when I run into problems like this is to read the commentary in the associated Federal Register. But that's not an option since FR copies from 1976 aren't available online.

I would be very grateful to anyone who can tell me what the difference between paragraphs 801.109(c) and (d) are below (I have aggressively trimmed preceding text for brevity). Barring that, if there is some super-secret part of the Internet where I can pick up a copy of 41 FR 6896 (Feb 13 1976...)


...
§ 801.109 - Prescription devices.

A device ....shall be exempt from section 502(f)(1) of the act if all the following conditions are met:


(a) The device is: ... in the possession of [licensed practitioners and various other sorts] and is to be sold only [to practitioners]


(b) The label of the device, other than surgical instruments, bears...The statement "Caution: Federal law restricts this device to sale by or on the order of a ____" and ... The method of its application or use.

(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.


(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder--piece labeling which calls attention to the name of the device but does not include indications or other use information.
...

Any help or comments would be much appreciated!

Arianna
:frust:
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: 801.109(c) vs (d): prescription labelling

(c) pertains to on/with/in-product labels and IFU inserts.

(d) pertains to marketing materials and advertising.

Obviously these are overlapping categories in many instances; but not always, thus the two statements.
 
K

Katalina

#4
Warnings - both device label and IFU

Regarding a professional use only device - I recently corrected a packaging engineer who told me that if a device warning is contained within the product IFU, it does not need to appear on the label. I said yes, this warning of possible allergic reaction also had to be contained on the label of the device itself. Not only do users not refer to the IFU if they have used the product before, but having the statement on the label is protection for the company. But because "labeling" includes both the label and the IFU, I am having trouble finding this in print to show him - that a warning must be included on the device label as well as in the device IFU. Can anyone assist me with this?
 
M

MIREGMGR

#5
The written rules are minimums. It's fine to meet minimum requirements for some information categories. I wouldn't see it as at all device-safety-prudent/liability-exposure-sensible to do just the minimum in regard to an allergy warning...especially given that some users do not/will not read the IFU.

Especially if, as I think your post implies, this is a change in the device's materials or performance that will not be apparent to a previous user of the device.

Does the on-product label contain an ISO-symbolic-for-MDD/text-for-FDA statement that the user must review the IFU?
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Does the on-product label contain an ISO-symbolic-for-MDD/text-for-FDA statement that the user must review the IFU?
In terms of liability, I think the reference to the IFU (symbolic or textual, as appropriate for the regulatory domain) would suffice. If the user fails to follow, it's their responsibility.

In terms of risk management / usability ("real need", "common sense"), the risk of the user not being aware of a contraindication should be evaluated based on the most up to date and relevant facts, and acted upon accordingly.

Cheers,
Ronen.
 
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