11794 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

1The term ‘‘extended-release’’ is used in this 

document to include all timed-release products, 

including products labeled as ‘‘sustained-release,’’ 

‘‘controlled-release,’’ ‘‘delayed-release,’’ or ‘‘longacting.’’ (See 21 CFR 310.502(a)(14).) 

2A ‘‘new drug’’ is defined by the FD&C Act as a 

drug that is not generally recognized, by experts 

qualified by scientific training and experience to 

evaluate the safety and effectiveness of drugs, as 

safe and effective for use under the conditions 

prescribed, recommended, or suggested in its 

labeling (section 201 of the FD&C Act (21 U.S.C. 

321(p)). 

3FDA’s regulations at (21 CFR 310.6(b)(1)) 

provide: ‘‘An identical, related, or similar drug 

includes other brands, potencies, dosage forms, 

salts, and esters of the same drug moiety as well as 

of any drug moiety related in chemical structure or 

known pharmacological properties.’’ 

4Section 310.6(b)(2)) provides that when 

qualified experts determine that the findings in a 

DESI notice are applicable to an IRS drug, that IRS 

drug is affected by the DESI notice. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0100] 

Drugs for Human Use; Unapproved 

and Misbranded Oral Drugs Labeled 

for Prescription Use and Offered for 

Relief of Symptoms of Cold, Cough, or 

Allergy; Enforcement Action Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to take enforcement action 

against unapproved and misbranded 

oral drug products that are labeled for 

prescription use and offered for relief of 

symptoms of cold, cough, or allergy and 

persons who manufacture or cause the 

manufacture of such products. These 

drug products are marketed without 

approved applications, and many are 

inappropriately labeled for use in 

infants and young children. These drug 

products must obtain FDA approval of 

a new drug application (NDA) or an 

abbreviated new drug application 

(ANDA), or comply with an FDA overthe-counter (OTC) drug final 

monograph, before marketing. 

DATES: This notice is effective March 3, 

2011. For information about 

enforcement dates, see SUPPLEMENTARY

INFORMATION, section IV. 

ADDRESSES: All communications in 

response to this notice should be 

identified with Docket No. FDA–2011– 

N–0100 and directed to Sakineh 

Walther, Division of New Drugs and 

Labeling Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Sakineh Walther, Division of New Drugs 

and Labeling Compliance, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002, 301– 

796–3349, e-mail: 

sakineh.walther@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Cold, Cough, and Allergy Products 

Covered by This Notice 

This Federal Register notice covers 

certain unapproved and misbranded 

drug products that are available in oral 

form and labeled for prescription use. 

These products are offered for relief of 

symptoms relating to cold, cough, or 

allergy, and include antitussives, 

expectorants, antihistamines, and nasal 

decongestants. This notice covers 

extended-release,1 tannate, and 

immediate-release drug products. 

B. Regulatory History of Products 

Covered by This Notice 

Many of the drug products covered by 

this notice contain active ingredients 

that were introduced into the 

marketplace without prior review for 

effectiveness. When initially enacted in 

1938, the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) required 

that FDA review and approve ‘‘new 

drugs’’ for safety, but not effectiveness, 

before they could legally be sold in 

interstate commerce.2 The FD&C Act 

made it the sponsor’s burden to show 

FDA that its drug was safe through the 

submission of an NDA. Between 1938 

and 1962, if a drug obtained approval, 

FDA considered drugs that were 

identical, related, or similar (IRS) 3 to 

the approved drug to be ‘‘covered’’ by 

that approval, and allowed those IRS 

drugs to be marketed without 

independent approval. 

In 1962, Congress amended the FD&C 

Act to require that new drugs be proven 

effective for their labeled indications, as 

well as safe. This amendment also 

required FDA to conduct a retrospective 

evaluation of effectiveness for all drugs 

approved as safe between 1938 and 

1962. FDA contracted with the National 

Academy of Sciences/National Research 

Council (NAS/NRC) to make an initial 

evaluation of the effectiveness of over 

3,400 products that had been approved 

only for safety between 1938 and 1962. 

The NAS/NRC reports for these drug 

products were submitted to FDA in the 

late 1960s and early 1970s. The Agency 

reviewed and reevaluated the reports 

and published its findings in Federal 

Register notices. FDA’s administrative 

implementation of the NAS/NRC reports 

was called the Drug Efficacy Study 

Implementation (DESI). DESI covered 

the approximately 3,400 products 

specifically reviewed by the NAS/NRC, 

as well as the even larger number of IRS 

products that entered the market 

without FDA approval.4 Many of the 

drug products covered by this notice 

contain the same active ingredients as 

drug products that were reviewed for 

effectiveness through the DESI process. 

All drugs covered by the DESI review 

are ‘‘new drugs’’ under the FD&C Act. If 

FDA’s final DESI determination 

classifies a drug product as ineffective 

for one or more indications, that drug 

product and those IRS to it can no 

longer be marketed for such indications 

and are subject to enforcement action as 

unapproved new drugs. If FDA’s final 

DESI determination classifies a drug 

product as effective for one or more of 

its labeled indications, the drug, and 

those IRS to it, can be marketed for such 

indications, provided each product is 

the subject of an application approved 

for safety and effectiveness. Those drug 

products with NDAs approved before 

1962 for safety therefore require 

approved supplements to their original 

applications if found effective under 

DESI; IRS drug products require an 

approved NDA or ANDA, as 

appropriate. Furthermore, labeling for 

these drug products may contain only 

those indications for which the DESI 

review found the product effective 

unless the firm marketing the product 

has received approval for additional 

indication(s). 

In the early 1970s, FDA granted 

temporary exemptions from the time 

limits established for completing certain 

phases of the DESI program for certain 

oral prescription drugs offered for relief 

of cold, cough, allergy, and related 

symptoms (38 FR 34481, December 14, 

1973). The exemptions were granted 

because of the close relationship 

between these prescription drugs and 

OTC drugs, which were subject to the 

ongoing OTC drug review. (See 21 CFR 

part 330.) Postponement of final 

evaluations of these DESI prescription 

products enabled the Agency to 

consider the recommendations of the 

OTC review panel in addition to any 

evidence submitted by NDA holders and 

other parties in response to various 

DESI notices covering relevant products. 

II. Safety Concerns With Unapproved 

New Drugs 

Because marketed unapproved new 

drug products have not been through 


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5The definition of ‘‘prescription drug’’ also 

includes a drug that is limited by an approved 

application to use under the professional 

supervision of a licensed practitioner (21 U.S.C. 

353(b)(1)(B)). This prong of the definition obviously 

does not apply to the unapproved extended-release 

drug products covered by this notice. 

6The definition of ‘‘prescription drug’’ also 

includes a drug that is limited by an approved 

application to use under the professional 

supervision of a licensed practitioner (21 U.S.C. 

353(b)(1)(B)). This prong of the definition obviously 

Continued 

FDA’s approval process, there may be 

safety risks associated with them. Some 

unapproved product labeling omits or 

modifies safety warnings or other 

information that is important to ensure 

safe use, such as drug interactions or 

potential adverse experiences. FDA is 

particularly concerned about pediatric 

labeling for these unapproved products. 

Some of the unapproved products 

covered by this notice are labeled and 

marketed for use in children as young 

as 1 month of age. Without reviewing 

applications for these products, FDA 

has no way to assess the scientific 

support, if any, for the use of these 

products in pediatric populations. 

FDA also has concerns regarding the 

manufacturing processes for 

unapproved new drugs and changes in 

the formulations of these products. 

When new drugs are marketed without 

FDA approval, FDA does not have an 

opportunity, prior to product marketing, 

to determine whether the manufacturing 

process for the drugs is adequate to 

ensure that they are of suitable quality. 

Additionally, there is no opportunity 

prior to marketing for FDA to review 

and approve proprietary names to 

minimize potential safety issues caused 

by product name confusion. In fact, 

FDA has received reports of name 

confusion associated with unapproved 

prescription products covered by this 

notice. Look-alike and sound-alike 

similarities between product names may 

contribute to medication errors and 

adverse events. 

Similarly, the new drug approval 

requirement allows the Agency to 

evaluate proposed changes to approved 

product formulations to ensure that 

such modifications meet FDA standards 

for safety and effectiveness and to 

ensure that formulation changes are 

accompanied, as necessary, by 

appropriate changes in product 

proprietary names or labeling, or other 

measures that may be warranted to 

minimize confusion and risks to 

patients. Modifications of product 

formulations that are not made under 

FDA’s drug approval process thus pose 

an increased risk of confusing 

healthcare practitioners and causing 

harm to consumers, such as underdose 

or overdose, particularly in pediatric 

patients. 

Finally, FDA has specific safety 

concerns about the products covered by 

this notice that are marketed as 

extended-release products. Many of 

these products contain amounts of 

active ingredients that could pose safety 

risks if the same amount of active 

ingredient were contained in an 

immediate-release dosage form. Without 

prior review of applications for these 

products, there is no assurance that the 

firms that market these products have 

established appropriate specifications 

for release of the active ingredients or 

that the products are properly 

formulated and manufactured to release 

their active ingredients to an extent and 

at a rate that is both safe and effective. 

III. Legal Status of Products Identified 

in This Notice 

A. Extended-Release Products 

Some of the products covered by this 

notice are sold as extended-release 

products. Since 1959, FDA has 

concluded that all products in 

extended-release dosage forms are new 

drugs requiring approved NDAs or 

ANDAs before being marketed (24 FR 

3756, May 9, 1959). Agency review of 

individual applications for extendedrelease products is needed to ensure 

that the finished product releases its 

active ingredient to an extent and at a 

rate that is both safe, with a predictable 

and controlled release of the dose, and 

effective, sustaining the intended effect 

over the entire dosing interval. Firms 

submitting applications are required to 

establish appropriate release 

specifications supported by clinical 

evidence, along with data showing that 

the finished product as manufactured by 

the firm releases its active ingredient 

according to those specifications. 

The Agency’s determination that all 

products in timed-release dosage form 

are new drugs requiring approved 

applications is codified at 21 CFR 

310.502(a)(14). Approval of an NDA 

under section 505(b) of the FD&C Act 

(21 U.S.C. 355(b)) or an ANDA under 

section 505(j) of the FD&C Act is 

required as a condition for marketing all 

such products. 

The unapproved extended-release 

drug products subject to this notice are 

all labeled for prescription use. 

Prescription drugs are defined under 

section 503(b)(1)(A) of the FD&C Act (21 

U.S.C. 353(b)(1)(A)) as drugs that, 

because of toxicity or other potentially 

harmful effect, are not safe to use except 

under the supervision of a practitioner 

licensed by law to administer such 

drugs.5 A drug that is labeled as a 

prescription drug but does not meet the 

definition of ‘‘prescription drug’’ under 

section 503(b)(1)(A) of the FD&C Act is 

misbranded under section 503(b)(4)(B) 

of the FD&C Act (21 U.S.C. 353(b)(4)(B)). 

Thus, if an extended-release drug 

covered by this notice is labeled as a 

prescription product, but does not meet 

the definition in section 503(b)(1)(A) of 

the FD&C Act, it is misbranded under 

section 503(b)(4)(B) of the FD&C Act. If 

an extended-release drug subject to this 

notice actually meets the definition of 

‘‘prescription drug’’ under 503(b)(1)(A), 

it is misbranded under section 502(f)(1) 

of the FD&C Act (21 U.S.C. 352(f)(1)), in 

that it fails to bear adequate directions 

for use. An approved prescription drug 

can satisfy the ‘‘adequate directions for 

use’’ requirement if it bears the NDAapproved labeling (§§ 201.100(c)(2) and 

201.115 (21 CFR 201.100(c)(2) and 

201.115)). Because the unapproved 

prescription extended-release drug 

products covered by this notice do not 

have approved applications with 

approved labeling, they fail to bear 

‘‘adequate directions for use,’’ and are 

misbranded under section 502(f)(1) of 

the FD&C Act. 

B. Tannates 

Some of the products covered by this 

notice contain active ingredients that 

are in tannate salt form (tannate drugs). 

FDA has reviewed the publicly available 

scientific literature on these ingredients, 

and has determined that unapproved 

oral drugs labeled for prescription use 

and offered for relief of symptoms of 

cold, cough, or allergy that contain the 

following ingredients are not generally 

recognized as safe and effective 

(GRASE): Brompheniramine tannate; 

carbetapentane tannate; carbinoxamine 

tannate; chlorpheniramine tannate; 

dexbrompheniramine tannate; 

dexchlorpheniramine tannate; 

dextromethorphan tannate; 

diphenhydramine tannate; ephedrine 

tannate; phenylephrine tannate; 

pseudoephedrine tannate; pyrilamine 

tannate; and triprolidine tannate. 

Therefore, products containing these 

ingredients are new drugs within the 

meaning of section 201(p) of the FD&C 

Act, and require approved NDAs or 

ANDAs before marketing. 

The unapproved tannate drug 

products subject to this notice are all 

labeled for prescription use. 

Prescription drugs are defined under 

section 503(b)(1)(A) of the FD&C Act as 

drugs that, because of toxicity or other 

potentially harmful effect, are not safe to 

use except under the supervision of a 

practitioner licensed by law to 

administer such drugs.6 A drug that is 


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does not apply to the unapproved tannate drug 

products covered by this notice. 

7 In addition to any other applicable 

requirements, firms that manufacture OTC drugs 

must comply with the labeling requirements at 21 

CFR 201.66. 

8The over 300 products reviewed by FDA 

represent all products in this category that FDA was 

able to identify. 

9The definition of ‘‘prescription drug’’ also 

includes a drug that is limited by an approved 

application to use under the professional 

supervision of a licensed practitioner (21 U.S.C. 

353(b)(1)(B)). This prong of the definition obviously 

does not apply to the unapproved immediaterelease drug products subject to this notice and 

containing ingredients that are included in the final 

OTC Cold Cough monograph, but with indications, 

dosing regimens, or both, that are inconsistent with 

that monograph. 

10The definition of ‘‘prescription drug’’ also 

includes a drug that is limited by an approved 

application to use under the professional 

supervision of a licensed practitioner (21 U.S.C. 

353(b)(1)(B)). This prong of the definition obviously 

does not apply to the unapproved immediaterelease drug products covered by this notice that 

contain active ingredients not included in the final 

OTC Cold Cough monograph. 

labeled as a prescription drug but does 

not meet the definition of ‘‘prescription 

drug’’ under section 503(b)(1)(A) of the 

FD&C Act is misbranded under section 

503(b)(4)(B) of the FD&C Act. Thus, if a 

tannate drug covered by this notice is 

labeled as a prescription product, but 

does not meet the definition in section 

503(b)(1)(A) of the FD&C Act, it is 

misbranded under section 503(b)(4)(B) 

of the FD&C Act. If a tannate drug 

covered by this notice actually meets 

the definition of ‘‘prescription drug,’’ it 

is misbranded under section 502(f)(1) of 

the FD&C Act, in that it fails to bear 

adequate directions for use. An 

approved prescription drug can satisfy 

the ‘‘adequate directions for use’’ 

requirement if it bears the NDAapproved labeling (21 CFR 201.100(c)(2) 

and 201.115). Because the unapproved 

prescription tannate drug products 

covered by this notice do not have 

approved applications with approved 

labeling, they fail to bear ‘‘adequate 

directions for use,’’ and are misbranded 

under section 502(f)(1) of the FD&C Act. 

C. Immediate-Release Products 

The remaining unapproved oral 

products covered by this notice are 

immediate-release products labeled for 

prescription use and offered for relief of 

symptoms associated with cold, cough, 

or allergy. The immediate-release 

products fall into the following three 

categories: 

1. Drugs Inappropriately Labeled for 

Prescription Use 

A small number of the immediaterelease products covered by this notice 

conform to the requirements of the final 

OTC monograph at 21 CFR part 341, 

‘‘Cold, Cough, Allergy, Bronchodilator, 

and Antiasthmatic Drug Products for 

Over-the-Counter Human Use’’ (the final 

OTC Cold Cough monograph), except 

that they are labeled for prescription use 

only. Section 503(b)(1) of the FD&C Act 

establishes the definition of a 

‘‘prescription drug.’’ Drug products that 

do not meet the definition of a 

prescription drug but are labeled for 

prescription use are misbranded under 

section 503(b)(4)(B) of the FD&C Act. If 

these drugs conform to the requirements 

of the final OTC Cold Cough 

monograph, they are not new drugs and 

they do not require an approved NDA or 

ANDA in order to be legally marketed 

OTC.7

2. Drugs Containing Ingredients 

Included in the Final OTC Cold Cough 

Monograph But Labeled With 

Nonconforming Indications or Dosing 

Regimens 

The majority of the immediate-release 

products covered by this notice are 

labeled for prescription use and contain 

ingredients that are included in the final 

OTC Cold Cough monograph, but have 

indications, dosing regimens, or both, 

that are inconsistent with that 

monograph. FDA has reviewed the 

indications and dosing regimens (dosing 

intervals and dosage amounts) in the 

labeling of over 300 such products, and 

has reviewed the publicly available 

scientific literature for studies of these 

products.8 In no case did FDA find 

literature sufficient to support a 

determination that one of these products 

was GRASE for relief of symptoms of 

cold, cough, or allergy. Therefore, these 

products are all ‘‘new drugs’’ within the 

meaning of section 201(p) of the FD&C 

Act, that require approved NDAs or 

ANDAs before marketing. 

The unapproved immediate-release 

drug products subject to this notice that 

contain ingredients that are included in 

the final OTC Cold Cough monograph, 

but with indications, dosing regimens, 

or both, that are inconsistent with that 

monograph, are all labeled for 

prescription use. Prescription drugs are 

defined under section 503(b)(1)(A) of 

the FD&C Act as drugs that, because of 

toxicity or other potentially harmful 

effect, are not safe to use except under 

the supervision of a practitioner 

licensed by law to administer such 

drugs.9 A drug that is labeled as a 

prescription drug but does not meet the 

definition of ‘‘prescription drug’’ under 

section 503(b)(1)(A) of the FD&C Act is 

misbranded under section 503(b)(4)(B) 

of the FD&C Act. Thus, if an immediaterelease drug covered by this notice is 

labeled as a prescription product, but 

does not meet the definition in section 

503(b)(1)(A), it is misbranded under 

section 503(b)(4)(B). If an immediaterelease drug covered by this notice does 

meet the definition of ‘‘prescription 

drug’’ in 503(b)(1)(A), it is misbranded 

under section 502(f)(1) of the FD&C Act, 

in that it fails to bear adequate 

directions for use. An approved 

prescription drug can satisfy the 

‘‘adequate directions for use’’ 

requirement if it bears the NDAapproved labeling (§§ 201.100(c)(2) and 

201.115). Because the unapproved 

prescription immediate-release drug 

products subject to this notice that 

contain ingredients that are included in 

the final OTC Cold Cough monograph, 

but with indications, dosing regimens, 

or both, that are inconsistent with that 

monograph, do not have approved 

applications with approved labeling, 

they fail to bear ‘‘adequate directions for 

use,’’ and are misbranded under section 

502(f)(1). 

3. Drugs Containing Ingredients Not 

Included in the Final OTC Cold Cough 

Monograph 

The remaining immediate-release 

products covered by this notice are 

labeled for prescription use and contain 

active ingredients that are not included 

in the final OTC Cold Cough 

monograph. FDA has reviewed the 

publicly available scientific literature on 

these ingredients, and has determined 

that the products covered by this notice 

and offered for relief of symptoms of 

cold, cough, or allergy that contain the 

following ingredients are not GRASE: 

Atropine; carbetapentane; 

cyproheptadine; dyphylline; 

hyoscyamine; methscopolamine nitrate; 

phenyltoloxamine; potassium 

guaiacosulfonate; promethazine; and 

scopolamine. Therefore, products 

covered by this notice containing these 

ingredients and marketed for relief of 

symptoms of cold, cough, or allergy are 

new drugs within the meaning of 

section 201(p) of the FD&C Act, and 

require approved NDAs or ANDAs prior 

to marketing. 

The unapproved immediate-release 

drug products that are subject to this 

notice and that contain active 

ingredients not included in the final 

OTC Cold Cough monograph are all 

labeled for prescription use. 

Prescription drugs are defined under 

section 503(b)(1)(A) of the FD&C Act as 

drugs that, because of toxicity or other 

potentially harmful effect, are not safe to 

use except under the supervision of a 

practitioner licensed by law to 

administer such drugs.10 A drug that is 


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11A ‘‘person’’ includes individuals, partnerships, 

corporations, and associations (21 U.S.C. 321(e)). 

12The Agency’s general approach for dealing with 

these products in an orderly manner is spelled out 

in the Marketed Unapproved Drugs CPG. That CPG, 

however, provides notice that any product that is 

being marketed illegally, and the persons 

responsible for causing the illegal marketing of the 

product, are subject to FDA enforcement action at 

any time. 

13For purposes of this notice, the term 

‘‘commercially used or sold’’ means that the product 

has been used in a business or activity involving 

retail or wholesale marketing and/or sale. 

14 If FDA finds it necessary to take enforcement 

action against a product covered by this notice, the 

agency may take action relating to all of the 

defendant’s other violations of the FD&C Act at the 

same time. For example, if a firm continues to 

manufacture or market a product covered by this 

notice after the applicable enforcement date has 

passed, to preserve limited agency resources, FDA 

may take enforcement action relating to all of the 

firm’s unapproved drugs that require applications at 

the same time. (See, e.g., United States v. Sage 

Pharmaceuticals, 210 F.3d 475, 479–480 (5th Cir. 

2000) (permitting the Agency to combine all 

violations of the act in one proceeding, rather than 

taking action against multiple violations of the act 

in ‘‘piecemeal fashion’’).) 

labeled as a prescription drug but does 

not meet the definition of ‘‘prescription 

drug’’ under section 503(b)(1)(A) is 

misbranded under section 503(b)(4)(B) 

of the FD&C Act. Thus, if an immediaterelease drug covered by this notice is 

labeled as a prescription product, but 

does not meet the definition in section 

503(b)(1)(A), it is misbranded under 

section 503(b)(4)(B). If a drug covered by 

this notice meets the definition of 

‘‘prescription drug’’ in 503(b)(1)(A), it is 

misbranded under section 502(f)(1) of 

the FD&C Act, in that it fails to bear 

adequate directions for use. An 

approved prescription drug can satisfy 

the ‘‘adequate directions for use’’ 

requirement if it bears the NDAapproved labeling (§§ 201.100(c)(2) and 

201.115). Because the unapproved 

prescription immediate-release drug 

products covered by this notice that 

contain active ingredients not included 

in the final OTC Cold Cough monograph 

do not have approved applications with 

approved labeling, they fail to bear 

‘‘adequate directions for use,’’ and are 

misbranded under section 502(f)(1) of 

the FD&C Act. 

IV. Notice of Enforcement Action 

Although not required to do so by the 

Administrative Procedure Act, the 

FD&C Act, or any rules issued under its 

authority, or for any other legal reason, 

FDA is providing this notice to 

persons 11 who are marketing 

unapproved and misbranded oral drug 

products labeled for prescription use 

and offered for relief of symptoms 

relating to cold, cough, or allergy that 

the Agency intends to take enforcement 

action against such products and those 

who manufacture them or cause them to 

be manufactured or shipped in 

interstate commerce. 

Manufacturing or shipping the drug 

products covered by this notice can 

result in enforcement action, including 

seizure, injunction, or other judicial or 

administrative proceeding. Consistent 

with policies described in the Agency’s 

guidance entitled ‘‘Marketed 

Unapproved Drugs—Compliance Policy 

Guide’’ (the Marketed Unapproved 

Drugs CPG) (http://www.fda.gov/

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

UCM070290.pdf), the Agency does not 

expect to issue a warning letter or any 

other further warning to firms marketing 

drug products covered by this notice 

prior to taking enforcement action. The 

Agency also reminds firms that, as 

stated in the Marketed Unapproved 

Drugs CPG, any unapproved drug 

marketed without a required approved 

application is subject to Agency 

enforcement action at any time. The 

issuance of this notice does not in any 

way obligate the Agency to issue similar 

notices or any notice in the future 

regarding marketed unapproved 

drugs.12

As described in the Marketed 

Unapproved Drugs CPG, the Agency 

may, at its discretion, identify a period 

of time during which the Agency does 

not intend to initiate an enforcement 

action against a currently marketed 

unapproved drug solely on the ground 

that it lacks an approved application 

under section 505 of the FD&C Act. 

With respect to drug products covered 

by this notice, the Agency intends to 

exercise its enforcement discretion for 

only a limited period of time because 

there are safety issues with respect to 

the products covered by this notice and 

numerous marketed products that have 

approved applications or comply with 

the applicable OTC drug final 

monograph are offered to treat 

symptoms relating to cold, cough, and 

allergy. Therefore, the Agency intends 

to implement this notice as follows. 

For the effective date of this notice, 

see the DATES section of this document. 

FDA intends to take enforcement action 

against any drug product covered by 

this notice that is not listed with the 

Agency in full compliance with section 

510 of the FD&C Act (21 U.S.C. 360) 

before March 2, 2011, and is 

manufactured, shipped, or otherwise 

introduced or delivered for introduction 

into interstate commerce by any person 

on or after March 3, 2011. FDA also 

intends to take enforcement action 

against any drug product covered by 

this notice that is listed with FDA in full 

compliance with section 510 of the 

FD&C Act but is not being commercially 

used or sold 13 in the United States on 

March 2, 2011 and that is manufactured, 

shipped, or otherwise introduced or 

delivered for introduction into interstate 

commerce by any person on or after 

March 3, 2011. 

However, for drug products covered 

by this notice that are commercially 

used or sold in the United States, have 

a National Drug Code (NDC) number 

listed with FDA, and are in full 

compliance with section 510 of the 

FD&C Act before March 2, 2011 

(‘‘currently marketed and listed’’), the 

Agency intends to exercise its 

enforcement discretion as follows. FDA 

intends to initiate enforcement action 

against any currently marketed and 

listed product covered by this notice 

that is manufactured on or after June 1, 

2011 or that is shipped on or after 

August 30, 2011.14 Further, FDA intends 

to take enforcement action against any 

person who manufactures or ships such 

products after these dates. Any person 

who has submitted or submits an 

application for a drug product covered 

by this notice but has not received 

approval must comply with this notice. 

The Agency, however, does not 

intend to exercise its enforcement 

discretion as outlined previously if the 

following apply: (1) A manufacturer or 

distributor of drug products covered by 

this notice is violating other provisions 

of the FD&C Act, including, but not 

limited to, violations related to FDA’s 

current good manufacturing practices, 

adverse drug event reporting, labeling or 

misbranding requirements other than 

those identified in this notice or (2) it 

appears that a firm, in response to this 

notice, increases its manufacture or 

interstate shipment of drug products 

covered by this notice above its usual 

volume during these periods. 

Nothing in this notice, including 

FDA’s intent to exercise its enforcement 

discretion, alters any person’s liability 

or obligations in any other enforcement 

action, or precludes the Agency from 

initiating or proceeding with 

enforcement action in connection with 

any other alleged violation of the FD&C 

Act, whether or not related to a drug 

product covered by this notice. 

Similarly, a person who is or becomes 

enjoined from marketing unapproved or 

misbranded drugs may not resume 

marketing of such products based on 

FDA’s exercise of enforcement 

discretion that is set forth in this notice. 

Drug manufacturers and distributors 

should be aware that the Agency is 

exercising its enforcement discretion as 

described previously only in regard to 


srobinson on DSKHWCL6B1PROD with NOTICES
11798 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

drug products covered by this notice 

that are marketed under an NDC number 

listed with the Agency in full 

compliance with section 510 of the 

FD&C Act before March 2, 2011. As 

previously stated, drug products 

covered by this notice that are currently 

marketed but not listed with the Agency 

on the date of this notice must, as of the 

effective date of this notice, have 

approved applications prior to their 

shipment in interstate commerce. 

Moreover, any person or firm that has 

submitted or submits an application but 

has yet to receive approval for such 

products is still responsible for full 

compliance with this notice. 

V. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the FD&C Act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

Agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

NDC number(s), and stating that the 

product(s) has (have) been 

discontinued. The letter should be sent 

to Sakineh Walther (see ADDRESSES). 

Firms should also update the listing of 

their products under section 510(j) of 

the FD&C Act to reflect discontinuation 

of products covered by this notice. FDA 

plans to rely on its existing records, 

including its drug listing records, or 

other available information when it 

targets violations for enforcement 

action. 

This notice is issued under the 

Federal Food, Drug, and Cosmetic Act 

(sections 502 and 505 (21 U.S.C. 352 

and 355)) and under authority delegated 

to the Assistant Commissioner for 

Policy under section 1410.21 of the FDA 

Staff Manual Guide. 

Dated: February 22, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4703 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Organ 

Transplantation; Notice of Meeting 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice; correction. 

SUMMARY: The Health Resources and 

Services Administration published a 

notice in the Federal Register of 

February 9, 2011 (76 FR 7223–7224) 

announcing an Advisory Committee on 

Organ Transplantation meeting on 

March 8, 2011. The type of meeting, 

time and place have been changed. 

Correction 

In the Federal Register of February 9, 

2011, in FR Doc. 2011–2839, on page 

7223, 2nd column, under the heading 

Department of Health and Human 

Services, Health Resources and Services 

Administration, Advisory Committee on 

Organ Transplantation; Notice of 

Meeting, change the Times and Place to 

read: 

The meeting will be an Audio 

Conference Call on March 8, 2011, from 

12 noon to 4 p.m. EST. To access the 

conference call, call the USA Toll Free 

Number 888–469–1090 and enter the 

Passcode 2741198. The conference call 

leader is Patricia A. Stroup. Participants 

should call no later than 11:45 a.m. EST 

in order for logistics to be set up. 

Participants are asked to register for the 

conference call by contacting Brittany 

Carey, HRM/Professional and Scientific 

Associates (PSA), the logistical support 

contractor for the meeting, at (703) 889– 

9033 or b_carey@team-psa.com. The 

registration deadline is March 7, 2011. 

The Department will try to 

accommodate those wishing to 

participate in the call. 

The next face-to-face ACOT meeting 

is planned for August 2011. Details 

regarding an August meeting will be 

published in a subsequent Federal 

Register notice. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–4755 Filed 3–2–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Member 

Conflict. 

Date: March 15, 2011. 

Time: 9 a.m. to 10 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C212, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Ramesh Vemuri, PhD, 

Chief, Scientific Review Branch, National 

Institute on Aging, National Institutes of 

Health, 7201 Wisconsin Avenue, Suite 2C– 

212, Bethesda, MD 20892, 301–402–7700, 

rv23r@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: February 25, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–4826 Filed 3–2–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 


srobinson on DSKHWCL6B1PROD with NOTICES