16158 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 

H–2B Final Rule also includes a new 

registration process, to precede the 

filing of applications. 

Applications filed under Labor 

Certification Process and Enforcement 

for Temporary Employment in 

Occupations Other Than Agriculture or 

Registered Nursing in the United States 

(H–2B Workers), and Other Technical 

Changes, 73 FR 78020, Dec. 19, 2008 

(the current regulation), must be sent to 

the Office of Foreign Labor 

Certification’s (OFLC’s) Chicago 

National Processing Center (CNPC) and 

postmarked no later than midnight 

April 22, 2012, the last day before the 

effective date of the H–2B Final Rule. 

An application filed up to the effective 

date of the H–2B Final Rule must still 

comply in full with the requirements of 

the current regulations. Applications 

postmarked on or after April 23, 2012 

will be adjudicated in accordance with 

the requirements described in the H–2B 

Final Rule. 

Any application filed under the 

current regulation that is postmarked on 

or after April 23, 2012 or later will be 

rejected, and the employer (and its agent 

or attorney) will be informed of the need 

to file a new application in accordance 

with the provisions of the new H–2B 

Final Rule. 

To ensure a smooth transition from 

the current regulation and allow the 

OFLC to make the necessary changes to 

its program operations to accommodate 

the new planned registration process, 

the Department noted in the H–2B Final 

Rule, at 20 CFR 655.11(j), that it would 

announce in the Federal Register a 

separate transition period for the 

registration process. Employers who file 

H–2B applications with a start date of 

need before October 1, 2013 will not be 

required to obtain the pre-approved H– 

2B registration under 20 CFR 655.15, 

and the Department will continue to 

adjudicate temporary need during the 

processing of applications by reviewing 

the employer’s statement of temporary 

need in Section B of the ETA Form 

9142. Employers filing H–2B 

applications on or after April 23, 2012 

with a start date of need on or after 

October 1, 2013, must comply with all 

the requirements contained in the 

registration process unless the OFLC 

publishes additional guidance in the 

Federal Register. 

Employers with questions are 

encouraged to submit such questions to 

H–2B.Regulation@dol.gov. The 

Department will provide responses in 

the form of Frequently Asked Questions 

(FAQs) on its Web site. 

Signed in Washington, this 14th day of 

March, 2012. 

Jane Oates, 

Assistant Secretary, Employment and 

Training Administration. 

[FR Doc. 2012–6580 Filed 3–19–12; 8:45 am] 

BILLING CODE 4510–FP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 211 

[Docket No. FDA–1997–N–0518] (formerly 

97N–0300) 

Current Good Manufacturing Practice 

in Manufacturing, Processing, Packing, 

or Holding of Drugs; Revision of 

Certain Labeling Controls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

packaging and labeling control 

provisions of the current good 

manufacturing practice (CGMP) 

regulations for human and veterinary 

drug products by limiting the 

application of special control 

procedures for the use of cut labeling to 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons. FDA is also permitting the use 

of any automated technique, including 

differentiation by labeling size and 

shape, that physically prevents incorrect 

labeling from being processed by 

labeling and packaging equipment when 

cut labeling is used. This action is 

intended to protect consumers from 

labeling errors more likely to cause 

adverse health consequences, while 

eliminating the regulatory burden of 

applying the rule to labeling unlikely to 

reach or adversely affect consumers. 

This action is also intended to permit 

manufacturers to use a broader range of 

error prevention and labeling control 

techniques than permitted by current 

CGMPs. 

DATES: This final rule is effective on 

March 20, 2013, except for the 

amendment adding § 211.122(g)(4), 

which is effective April 19, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Brian Hasselbalch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4364, 

Silver Spring, MD 20993–0002, 301– 

796–3279, email: 

brian.hasselbalch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 29, 

1997 (62 FR 40489) (the proposed rule), 

FDA proposed to amend the packaging 

and labeling control provisions of the 

CGMP regulations for human and 

veterinary drug products by limiting the 

application of special control 

procedures for the use of cut labeling to 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons, and to permit the use of any 

automated technique, including 

differentiation by labeling size and 

shape, that physically prevents incorrect 

labeling from being processed by 

labeling and packaging equipment when 

cut labeling—single labels for 

individual drug products that are ‘‘cut’’ 

from a sheet or roll of labels—is used. 

Persistent problems with drug 

product mislabeling and subsequent 

recalls led FDA in 1987 and in 1990 to 

review labeling procedures and product 

recalls. The review identified gangprinted and cut labeling as a leading 

cause of labeling mixups. Gang-printed 

labeling is defined in § 210.3(b)(22) (21 

CFR 210.3(b)(22)) as labeling derived 

from a sheet of material on which more 

than one item of labeling is printed. 

Each sheet includes labeling for a 

variety of products and, because of this, 

labeling for individual drug products 

must be separated from the labeling for 

other products. When labels are gangprinted, the labels for different drug 

products or different strengths for the 

same drug product are processed 

together, making them especially 

susceptible to mixups. Similarly, cut 

labeling is commonly placed in separate 

stacks before being transported to 

packaging and labeling lines for 

application to appropriate products. 

FDA found that stacks of labeling of 

similar size, shape, and color could 

easily be intermixed and, if the printer 

or manufacturer did not detect the error, 

incorrect labeling could be applied and 

a mislabeled drug product distributed. 

To reduce the frequency and likelihood 

of such mislabeling, FDA, in the Federal 

Register of August 3, 1993 (58 FR 

41348), amended the packaging and 

labeling control provisions of the CGMP 

regulations in part 211 (21 CFR part 

211) to provide specific conditions for 

the use of all gang-printed and cut 

labeling. Under § 211.122(f), use of 

gang-printed labeling for different drug 

products, or different strengths or net 


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contents of the same product, is 

prohibited unless the labeling from 

gang-printed sheets is adequately 

differentiated by size, shape, or color. 

Under § 211.122(g), packaging and 

labeling operations must use one of 

three special control features if cut 

labeling is used: (1) Packaging and 

labeling lines must be dedicated to each 

different strength of each different drug 

product; (2) appropriate electronic or 

electromechanical equipment must be 

used to conduct a 100 percent 

examination for correct labeling during 

or after completion of finishing 

operations; or (3) where labeling is 

hand-applied, use of visual inspection 

to conduct a 100 percent examination 

for correct labeling during or after 

completion of finishing operations must 

be performed by one person and 

independently verified by a second 

person. 

To further limit the potential for 

mislabeling, FDA also required written 

procedures for the identification and 

handling of filled drug product 

containers not immediately labeled 

(§ 211.130(b)). FDA also amended 

§ 211.125(c) to exempt manufacturers 

that use automated 100 percent 

examination for correct labeling from 

the label reconciliation requirements. 

FDA also defined gang-printed labeling 

at § 210.3(b)(22). The final rule applied 

to all types of labeling, including 

product inserts, multiunit containers 

packaged in individual containers, and 

shipping containers. 

In May 1994, FDA received two 

citizen petitions from several trade 

associations requesting, among other 

things, that FDA consider additional 

comments on the application of 

§ 211.122(g) to items of labeling other 

than the immediate container label, and 

requesting additional time to obtain, 

install, or validate equipment necessary 

to comply with the August 3, 1993 final 

rule. In response to these requests, FDA 

extended the compliance date to 

August 3, 1995, for § 211.122(g) as it 

applies to labeling other than immediate 

container labels, and opened the 

administrative record for comments on 

the scope of § 211.122(g). All other 

provisions of the August 3, 1993, final 

rule became effective on August 3, 1994. 

To adequately assess comments 

received during the extended comment 

period and provide industry additional 

time to comply with the regulation, FDA 

published several notices extending the 

compliance date for § 211.122(g), as it 

applies to labeling other than immediate 

container labels, to August 2, 1996, to 

August 1, 1997, and, in the July 29, 

1997, Federal Register (62 FR 40447), 

until the effective date of this final rule. 

FDA evaluated the comments 

received during the extended comment 

period, met with industry 

representatives, reviewed recall data to 

determine the danger to consumers from 

errors in different types of drug product 

labeling, and surveyed packaging and 

labeling control technology. On July 29, 

1997, FDA issued a proposed rule to 

narrow the scope of § 211.122(g) and to 

expand the permissible control 

procedures. This rule finalizes the July 

29, 1997, proposed rule. As described in 

more detail in section II of this 

document, the final rule adopts the 

proposed codified without change. 

II. Description of the Final Rule 

A. Scope of § 211.122 

The first sentence of current states: ‘‘If 

cut labeling is used, packaging and 

labeling operations shall include one of 

the following special control 

procedures.’’ The final rule amends the 

first sentence of § 211.122(g) to state: ‘‘If 

cut labeling is used for immediate 

container labels, individual unit 

cartons, or multiunit cartons containing 

immediate containers that are not 

packaged in individual unit cartons, 

packaging and labeling operations shall 

include one of the following special 

control procedures.’’ Thus, instead of 

applying to all types of labeling as 

required in the August 3, 1993, final 

rule, the control procedures specified in 

revised § 211.122(g) apply only to cut 

labeling used for immediate container 

labels, individual unit cartons, or 

multiunit cartons containing immediate 

containers that are not packaged in 

individual unit cartons. This 

amendment is intended to protect 

consumers from labeling errors that are 

more likely to cause adverse health 

consequences, while eliminating the 

regulatory burden of applying the rule 

to labeling unlikely to reach or 

adversely affect consumers. As 

explained in the proposed rule, the 

immediate container label is most likely 

to be read by consumers. The individual 

unit carton labeling is the outermost 

container in which a drug product is 

commonly marketed at retail, and many 

consumers read this labeling when 

deciding whether to purchase a product. 

When using multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons (for example, sterile dosage 

forms in tray packs in which immediate 

containers lack unit cartons), consumers 

and health professionals are more likely 

to rely on labeling on the outer 

multiunit container than to examine the 

labeling on the individual drug product 

immediate containers. 

B. Special Control Procedures 

Currently, there are three control 

procedures delineated in § 211.122(g)(1) 

through (g)(3): (1) Dedication of labeling 

and packaging lines to each different 

strength of each different drug product; 

(2) use of appropriate electronic or 

electromechanical equipment to 

conduct a 100 percent examination for 

correct labeling during or after 

completion of finishing operations; or 

(3) use of visual inspection to conduct 

a 100 percent examination for correct 

labeling during or after completion of 

finishing operations for hand-applied 

labeling. The visual inspection must be 

performed by one person and 

independently verified by a second 

person. The final rule amends 

§ 211.122(g) to add a fourth alternative 

special control procedure for packaging 

and labeling operations when cut 

labeling is used that provides for more 

flexibility in determining adequate 

controls. The fourth control, added at 

§ 211.122(g)(4), states: ‘‘Use of any 

automated technique, including 

differentiation by labeling size and 

shape, that physically prevents incorrect 

labeling from being processed by 

labeling and packaging equipment.’’ As 

noted in the proposed rule (62 FR 40489 

at 40491), this additional control 

procedure is being added because FDA 

believes that this will provide 

manufacturers with the widest possible 

latitude in selecting appropriate labeling 

control technologies. It will permit the 

use of a number of automated 

techniques that will physically prevent 

incorrect labeling from being processed 

by packaging and labeling equipment. A 

labeling control method using size and 

shape as part of an automated technique 

that prevents incorrect labeling from 

being processed by labeling and 

packaging lines provides equivalent 

labeling control protection, through 

prevention, as do the other special 

control procedures through surveillance 

or dedication of labeling and packaging 

lines. An acceptable automated 

technique will allow labeling and 

packaging operations to operate only if 

correct labeling unique to a given 

product (for example, a specific size) is 

used. 

III. Responses to Comments on the 

Proposed Rule 

FDA received three comments on the 

proposed rule which raised a limited 

number of issues. The specific issues 

raised by the commenters are described 

in this section III. 

(Comment 1) One comment said that 

the final rule should permit all effective 

means of label control, whether they 


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involve automated systems or 

nonautomated systems. The comment 

said that FDA has indicated that both 

automated and nonautomated systems 

of label control are equally effective in 

preventing label mixups. The comment 

cited the June 23, 1989, proposed rule 

and the August 3, 1993, final rule, and 

noted that FDA said that three label 

control practices were not involved in 

any of the recalls attributed to label 

mixups (i.e., the use of labels 

differentiated by size, shape, or color; 

the use of dedicated packaging lines; 

and the use of electronic label 

verification systems that validate the 

labeling of each product during 

finishing operations (100 percent label 

inspection)). The comment said that 

these label control practices include 

both automated (the use of electronic 

label verification systems that validate 

the labeling of each product during 

finishing operations) and nonautomated 

(use of labels differentiated by size, 

shape, or color and the use of dedicated 

packaging lines) methods. 

The comment also said that industry’s 

experiences with certain electronic and 

electromechanical control systems have 

shown inconsistent results, and 50–60 

percent of the electronic systems that 

were installed during the recent past 

(the comment was submitted in 1997) 

could not be used because of lack of 

reliability against the zero-defect 

standard. The comment said that some 

automated systems are not robust 

enough to identify ‘‘bad’’ labels 100 

percent of the time, at certain line 

speeds and under certain conditions, 

and the systems erred with 

unacceptable levels of false positives 

(that is, flagging ‘‘good’’ labels as 

‘‘bad’’). 

The comment said the special control 

procedures under proposed § 211.122(g) 

should be modified to allow companies 

to document a system of control that 

best fits the unique abilities of each 

particular company, without requiring 

any one particular control system (for 

example, electronic or 

electromechanical controls) to be used 

across the entire industry. The comment 

said this approach would allow the 

implementation of technology 

appropriate for the individual plants 

involved. 

The comment noted that many 

companies currently use multiple layers 

of control in their labeling operations 

that have yielded very robust systems of 

total control, and they should not be 

required to add another special layer of 

control that may not improve their total 

system. The comment stated that FDA 

should permit additional automated and 

nonautomated methods of control for 

items of labeling within the scope of 

§ 211.122(g). Differentiation by size, 

shape, or color or by any other effective, 

validated means should be permitted, 

whether automated or not. The 

comment described other types of layers 

of control that should be permitted, 

including labeling design to minimize 

mixups, using labeling suppliers that 

have excellent internal control, using 

label control rooms, proper purging of 

labeling lines, using computerized 

material requirements planning systems, 

online checks of operations, and 

reconciliation of labeling. 

Another comment said that the 

proposed rule would limit industry’s 

choice of control measures, and too 

great an emphasis was placed on ‘‘high 

tech’’ electronic verification systems. 

The comment stated that traditional 

methods of label control have proven to 

be just as effective. The comment said 

that industry is largely operating using 

traditional label control measures along 

with some high tech electronic 

verification systems as part of an overall 

system of label control. These 

traditional systems consist of multilevel 

control measures that work together to 

ensure that label mixups are avoided. 

The comment said that the use of 

electronic systems alone will not 

provide this level of assurance, because 

electronic systems are not 100 percent 

effective and often give false alarms in 

labeling operations that can lead to 

operator complacency and/or inefficient 

line operation. The comment expressed 

doubt that the use of electronic 

verification systems would improve 

systems currently in place at its 

company. The comment recommended 

other control measures as part of an 

overall system for label control that 

should be considered by FDA, 

including: (1) An ongoing program to 

assess the label supplier’s operations 

and controls; (2) labeling designed to 

avoid mixups such as differentiation by 

size, shape, and color; (3) procedures 

addressing art/label approval; (4) a 

multilevel control system that 

incorporates personnel training, label 

inspection, line clearance, and other 

control procedures designed to avoid 

mixups; and (5) a validation of such 

systems that gives assurance that label 

controls are acceptable. 

(Response) First, the Agency believes 

that it is important to emphasize that 

one of the special controls listed in 

§ 211.122(g) must be used only when 

cut labeling is used for the types of 

labeling described in § 211.122(g). 

Manufacturers have significant 

additional flexibility to use different 

labeling controls for other types of 

labeling. 

When cut labeling is used for the 

identified types of labeling, at least one 

of the special controls in § 211.122(g) 

must be used. The final rule permits the 

choice of a special control from one of 

four options specified in § 211.122(g)(1) 

through (g)(4). Two are nonautomated 

controls: dedication of lines (paragraph 

(g)(1)) and visual inspection for hand 

applied labels (paragraph (g)(3)). Two 

are automated controls: Electronic or 

electromechanical examination to 

conduct a 100-percent examination for 

correct labeling during or after 

completion of finishing operations 

(paragraph (g)(2)), and use of any 

automated technique that physically 

prevents incorrect labeling from being 

processed by labeling and packaging 

equipment (paragraph (g)(4)). This 

provides industry with a number of 

options, including manual, electronic, 

electromechanical, and automated 

systems. It also permits broad discretion 

to industry to select appropriate 

electronic or automated systems for this 

purpose, and to ‘‘layer’’ different 

controls, if desired, as long as at least 

one of the options listed in paragraph (g) 

is used as one of the layers. 

However, FDA disagrees that 

additional nonautomated special 

controls, in addition to dedicated lines 

or visual inspection, should be added to 

paragraph (g). As we noted in the 

proposed rule (62 FR 40489 at 40491), 

nonautomated (i.e., manual) 

differentiation of size and shape as a 

labeling control does not provide 

adequate protection from labeling 

mixups when cut labeling is used. It is 

the increased opportunity for human 

error afforded by the process of cutting, 

sorting, and subsequent handling of 

different items of labeling that has 

caused labeling mixups and recalls. One 

of the goals of this rulemaking is to 

reduce the likelihood for such human 

error through the increased use of 

automated labeling control systems and 

through the elimination of manual label 

differentiation by size and shape. In 

addition, in response to the 

commenter’s concern that electronic 

systems are not sufficiently reliable, we 

believe that development and use of 

advanced code scanning equipment has 

made many current electronic 

verification systems accurate and 

reliable. For example, all prescription 

drug products (with limited exceptions), 

biological products, and certain overthe-counter (OTC) drug products are 

now required by 21 CFR 201.25 to bear 

on the label a bar code containing, at a 

minimum, the drug’s NDC (National 

Drug Code). Electronic systems can use 

these codes to scan the labels as part of 


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the label controls. These and other 

advanced scanning techniques have 

made current electronic systems reliable 

to the 100 percent standard. 

If cut labeling is used, the choice of 

one of the four special control 

procedures listed above should allow 

manufacturers to document a system of 

control that best fits the unique abilities 

of each particular manufacturer without 

requiring any one particular control 

system to be used. The final rule 

permits manufacturers considerable 

latitude under § 211.122(g)(1) through 

(g)(4) in establishing control procedures 

over cut labeling, and is sufficiently 

flexible to permit technological 

innovation in automated labeling 

inspection systems. For example, under 

the final rule, a labeling control method 

designed by an individual manufacturer 

could incorporate electronic or 

electromechanical equipment or the use 

of a visual inspection to conduct a 100 

percent examination for correct labeling. 

Moreover, manufacturers are free to use 

one of the specifically enumerated 

special controls in § 211.122(g) in 

combination with any other special or 

general labeling controls. The rule 

merely establishes that, at a minimum, 

one of the four enumerated special 

controls must be used when the 

identified types of cut labeling are used. 

Accordingly, many of the alternative 

special and general controls discussed 

by the commenters could also be used 

in conjunction with one of the 

enumerated special controls. 

The comments suggest that this rule 

will mandate that manufacturers who 

currently have effective label control 

systems but are not currently using one 

of the controls enumerated in 

§ 211.122(g)(1) through (g)(4) must 

change their system to include one of 

the four special controls. FDA points 

out that this would only be true for 

situations where cut labeling is 

currently being used for those labels 

subject to the enforcement discretion 

period (labels other than immediate 

container labels) if the manufacturer is 

not currently voluntarily using one of 

the enumerated special controls. 

Processes using cut labeling for 

immediate containers labels (the bulk of 

the labels covered by this change) were 

not subject to enforcement discretion 

and would already be required to use 

one of the three special controls in 

current § 211.122(g)(1) through (g)(3). 

The only change made by this rule for 

those labeling processes would be the 

addition of a new option to meet the 

requirement of subsection (g). Those 

lines would not be required to make any 

change by this final rule. 

(Comment 2) One comment said that 

the controls for cut labeling used for 

multiunit cartons containing immediate 

containers that are not packaged in 

individual unit cartons (§ 211.122(g)) 

should not apply to OTC drug product 

shelf-packs. The comment explained 

that OTC drug products are sometimes 

packaged in what could be called 

multiunit cartons containing immediate 

containers that are not packaged in 

individual unit cartons. These are often 

called ‘‘shelf-packs’’ or ‘‘trays.’’ The 

comment gave the following examples: 

antacid tablets packaged in individual 

rolls and placed in a tray near the 

checkout of a drugstore or supermarket; 

bottles of sunscreen products displayed 

in an end-unit in a store for convenience 

and added display space; and analgesic 

powders in printed envelopes placed in 

a tray to keep them upright on the store 

shelf. The comment noted that for these 

products the immediate containers are 

not packaged in individual unit cartons. 

However, complete labeling is on the 

individual packages, and neither 

consumers nor health professionals rely 

on the information on the tray or endunit to purchase or use the product. The 

comment said that the proposed rule 

could be interpreted to apply to OTC 

shelf-packs, trays, or end units, but that 

special control procedures are not 

needed for these products because their 

labeling is not relied on to purchase the 

products. In addition, because the 

labeling on the shelf pack, tray, or end 

unit itself does not accompany the 

product to its point of use, it is not 

relied on by the consumer to use the 

product. Therefore, the comment said, 

no significant additional protection to 

the public health and safety would 

result from special control procedures 

for these products. The comment 

recommended that proposed 

§ 211.122(g) be revised to read: ‘‘* * * 

multiunit cartons containing immediate 

containers of prescription drugs that are 

not packaged in individual unit cartons 

* * *.’’ 

(Response) FDA does not agree that 

the final rule should specifically 

exclude OTC shelf-packs. First, FDA 

disagrees with the assertion that 

consumers and health professionals do 

not rely on the information on the tray 

or end-unit to purchase or use the 

product. Although mislabeling of 

immediate containers poses the most 

obvious threat to public health and 

safety, a considerable danger is also 

posed by errors in the labeling that 

influences consumer selection of the 

product at the time of purchase. Indeed, 

we believe that, in the context of shelfpacks, these requirements are more 

important for OTC drugs for which there 

is not necessarily a health care 

professional involved to help ensure 

proper product selection. FDA does not 

agree that the rule would significantly 

affect the use of shelf-packs because 

shelf-packs rely on other packaging and 

labeling operations and infrequently use 

cut labeling. To the extent that OTC 

shelf-packs do use cut labeling, the 

special control procedures allow 

manufacturers considerable latitude in 

establishing appropriate controls. 

(Comment 3) One comment said the 

rule should not apply to drug products 

in preprinted immediate containers 

such as tubes, vials, cans, bottles, 

pouches, and blister packages. The 

comment requested that the final rule be 

revised to specifically exclude 

preprinted immediate containers. 

(Response) FDA agrees that the rule 

does not apply to drug products in 

preprinted immediate containers 

because the likelihood of labeling 

mixups appears to be remote and 

because preprinted drug product 

containers are still subject to existing 

general labeling controls to prevent 

mixups. Preprinted immediate 

containers include tubes, vials, cans, 

bottles, pouches, and blister packages 

where the labeling is directly ‘‘inked’’ 

into the package. FDA does not agree 

that it is necessary to amend § 211.122 

to expressly exclude drug products in 

preprinted immediate containers 

because, as adopted in this final rule, 

§ 211.122 does not apply to preprinted 

containers. 

(Comment 4) One comment requested 

that the rule be finalized only as 

currently applied to immediate 

container labels in § 211.122(g) and not 

expanded to individual unit cartons or 

multiunit cartons containing immediate 

containers that are not packaged in 

individual unit cartons. 

(Response) As explained earlier in 

this preamble, the control procedures 

specified in § 211.122(g) apply to cut 

labeling used for immediate container 

labels, individual unit cartons, or 

multiunit cartons containing immediate 

containers that are not packaged in 

individual unit cartons. This is intended 

to protect consumers from labeling 

errors that are more likely to cause 

adverse health consequences, while 

eliminating the regulatory burden of 

applying the rule to labeling unlikely to 

reach or adversely affect consumers. 

The immediate container label is most 

likely to be read by consumers. The 

individual unit carton labeling is the 

outermost container in which a drug 

product is commonly marketed at retail, 

and many consumers read this labeling 

when deciding whether to purchase a 


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product. When using multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons (for example, sterile dosage 

forms in tray packs in which immediate 

containers lack unit cartons), consumers 

and health professionals are likely to 

rely both on labeling on the outer 

multiunit container as well as the 

labeling on the individual drug product 

immediate containers. 

(Comment 5) One comment 

questioned the use of the term ‘‘gangprinted materials’’ in the following 

paragraph of the proposed rule: ‘‘FDA 

notes, however, that nonautomated (i.e., 

manual) differentiation of size and 

shape as a labeling control does not 

provide adequate protection from 

labeling mixups. It is the increased 

opportunity for human error afforded by 

the process of cutting, sorting, and 

subsequent handling of different items 

of labeling from gang-printed materials 

that has caused labeling mixups and 

recalls. One of the goals of this proposed 

rulemaking is to reduce the likelihood 

for such human error through the use of 

automated labeling control systems’’ (62 

FR 40489 at 40491 and 40492). 

The comment said that this paragraph 

appears to equate cut labeling with 

gang-printing. The comment noted that 

gang-printing is prohibited under 

§ 211.122(f): ‘‘Use of gang-printed 

labeling for different drug products, or 

different strengths or net contents of the 

same product, is prohibited unless the 

labeling from gang-printed sheets is 

adequately differentiated by size, shape, 

or color.’’ In addition, gang-printed 

labeling is defined in § 210.3(b)(22) as 

‘‘labeling derived from a sheet of 

material on which more than one item 

of labeling is printed.’’ The comment 

noted that the printing of repetitions of 

the same item of labeling on the same 

sheet results in cut labeling, as the 

individual repetitions of the item are cut 

from the sheet for use. The comment 

said that this is not gang-printing and 

does not present the same opportunity 

‘‘for human error afforded by the 

process of cutting, sorting, and 

subsequent handling of different items 

of labeling’’ as does gang-printing, 

because the labeling is all identical. 

(Response) FDA acknowledges that 

the distinction between ‘‘gang-printed 

labeling’’ and ‘‘cut labeling’’ in the July 

29, 1997, proposed rule (62 FR 40490) 

may have caused confusion among some 

readers. Gang-printed labeling, as 

explained earlier in this preamble, is 

defined in § 210.3(b)(22) (21 CFR 

210.3(b)(22)) as labeling derived from a 

sheet of material on which more than 

one item of labeling is printed. For 

example, a sheet of material that 

contains labeling for different strengths 

of a drug product is considered to be 

gang-printed. In contrast, cut labeling, 

as described in the August 3, 1993, final 

rule (58 FR at 41350), refers to items of 

labeling that have been detached or 

‘‘cut’’ from printed stock material. This 

stock material may or may not be gangprinted; it may contain labeling for 

different drug products or different 

strengths of the same drug product or it 

may contain identical labeling for the 

same drug product. The printing 

method of the stock material has no 

bearing on whether labeling is 

considered to be cut labeling. The 

defining feature of cut labeling is simply 

that it is ‘‘cut.’’ After being cut, such 

labeling is commonly sorted by type or 

strength of drug product (if it is not 

identical), placed into separate, 

corresponding stacks, and then 

transported to the packaging and 

labeling lines for application to the 

appropriate product. Cut labeling is 

problematic because the items, when 

cut and placed into individual stacks for 

application to different drug products, 

are easily mixed up. FDA found that 

stacks of labeling of similar size, shape, 

and color could easily be intermixed 

and, if the manufacturer did not detect 

the error, incorrect labeling could be 

applied and a mislabeled drug product 

distributed. 

(Comment 6) One comment said that 

§ 211.122(g)(3) should be revised to 

include the sentence: ‘‘Such a 100 

percent examination must be conducted 

by one person and independently 

verified by a second person.’’ The 

comment said by omitting this phrase 

the public might be led to the 

presumption that the ‘‘verification by a 

second person’’ is no longer required. 

(Response) FDA notes that it did not 

propose to amend § 211.122(g)(3), nor is 

that section being amended by this final 

rule. Moreover, because the first 

sentence of § 211.122(g)(3) already states 

that ‘‘a 100-percent examination’’ for 

correct labeling is required, repeating 

the phrase ‘‘100-percent’’ in the second 

sentence of paragraph (3), as proposed 

by the commenter, would be redundant. 

Therefore, the final rule does not adopt 

the change suggested by the commenter. 

(Comment 7) One comment said that 

the proposed compliance date of 6 

months after publication of the final 

rule should be extended to 1 year to 

adequately implement any new 

controls. 

(Response) As requested by the 

comment, we are providing an effective 

date of 1 year from the date of 

publication of this final rule as it 

applies to labels that had not previously 

been covered by this regulation. The 

application of § 211.122(g) to labeling 

other than labeling used for immediate 

container labels has been stayed since 

August 3, 1994. Although it lifts the 

stay, the final rule also narrows the 

applicability of § 211.122(g) so that, in 

addition to immediate container 

labeling, the only other labeling that is 

subject to final § 211.122(g) is cut 

labeling used for individual unit 

cartons, or multiunit cartons containing 

immediate containers that are not 

packaged in individual unit cartons. We 

believe 1 year will be sufficient to 

permit companies to adopt an 

appropriate control from § 211.122(g)(1) 

through (g)(4) for those limited 

additional categories of cut labeling. 

The shorter implementation period 

applicable to cut labeling used for 

immediate container labels (which make 

up the majority of cut labeling used) 

reflects the fact that sections 

211.122(g)(1) through (g)(3) as they 

apply to such labels have been effective 

since August 3, 1994. As to those labels, 

this final rule merely adds an additional 

control option for the appropriate use of 

cut labeling (i.e., § 211.122(g)(4)). 

Accordingly, as to those labels, we are 

making this rule effective 30 days after 

its publication in the Federal Register. 

If they wish, labelers may continue to 

use one of the appropriate controls 

listed in § 211.122(g)(1) through (g)(3) 

that have been applicable to those labels 

since 1994. Adoption of the additional 

control option in § 211.122(g)(4) added 

by this final rule is purely voluntary 

but, since the regulation provides an 

alternative method of compliance, there 

is no reason to delay its applicability 

beyond the statutory 30-day period. 

IV. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this rule reduces the 

scope of the 1993 final rule and 


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Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 16163 

provides manufacturers greater 

flexibility to meet regulatory 

requirements, the Agency certifies that 

the final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The purpose of this final rule is to 

protect consumers from those labeling 

errors that are more likely to cause 

adverse health consequences, while 

eliminating the regulatory burden of 

applying the rule to labeling unlikely to 

reach or adversely affect consumers. 

This rule amends the 1993 final rule by 

limiting the scope to cut labeling for 

immediate container labels, individual 

unit cartons, and multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons. This rule also increases 

flexibility for firms selecting special 

labeling control procedures by adding a 

provision for the use of any automated 

technique, including differentiation by 

size and shape, that physically prevents 

incorrect labeling from being processed 

by labeling and packaging equipment. 

Therefore, this rule is expected to have 

a positive economic impact on drug 

manufacturers that would otherwise be 

subject to the more stringent 

requirements under current regulations. 

V. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VI. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

List of Subjects in 21 CFR Part 211 

Drugs, Labeling, Laboratories, 

Packaging and containers, Prescription 

drugs, Reporting and recordkeeping 

requirements, Warehouses. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 211 is 

amended as follows: 

PART 211—CURRENT GOOD 

MANUFACTURING PRACTICE FOR 

FINISHED PHARMACEUTICALS 

■ 1. The authority citation for 21 CFR 

part 211 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 

■ 2. Section 211.122 is amended by 

revising the introductory text of 

paragraph (g) and by adding paragraph 

(g)(4) to read as follows: 

§ 211.122 Materials examination and usage 

criteria. 

* * * * * 

(g) If cut labeling is used for 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons, packaging and labeling 

operations shall include one of the 

following special control procedures: 

* * * * * 

(4) Use of any automated technique, 

including differentiation by labeling 

size and shape, that physically prevents 

incorrect labeling from being processed 

by labeling and packaging equipment. 

* * * * * 

Dated: March 13, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6502 Filed 3–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

28 CFR Parts 35 and 36 

[CRT Docket No. 122; AG Order No. 3326– 

2012] 

RIN 1190–AA68 

Nondiscrimination on the Basis of 

Disability by Public Accommodations 

and in Commercial Facilities; 

Swimming Pools 

AGENCY: Civil Rights Division, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: By this rule, the Department 

of Justice is extending the date for 

compliance with certain requirements 

in the 2010 Americans with Disabilities 

Act (ADA) Standards for Accessible 

Design (2010 Standards) that relate to 

provision of accessible entry and exit for 

swimming pools, wading pools, and 

spas. This final rule, based on a finding 

of good cause, changes the date for 

compliance from March 15, 2012, to 

May 21, 2012 in order to allow 

additional time to address 

misunderstandings regarding 

compliance with these ADA 

requirements. Some pool owners and 

operators believed that taking certain 

steps would always satisfy their 

obligations under the ADA when in fact 

those steps would not necessarily result 

in compliance with the ADA 

regulations. 

DATES: Effective on March 15, 2012, the 

compliance date for 28 CFR 

35.150(b)(1), (b)(2)(ii), and 28 CFR 

36.304(d)(2)(iii) for sections 242 and 

1009 of the 2010 Standards is delayed 

to May 21, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Allison Nichol, Chief, Disability Rights 

Section, Civil Rights Division, U.S. 

Department of Justice, at (202) 307–0663 

(voice or TTY). This is not a toll-free 

number. Information may also be 

obtained from the Department’s toll-free 

ADA Information Line at (800) 514– 

0301 (voice) or (800) 514–0383 (TTY). 

This rule is also available in an 

accessible format on the ADA Home 

Page at http://www.ada.gov. You may 

obtain copies of this rule in large print 

or on computer disk by calling the ADA 

Information Line listed above. 

SUPPLEMENTARY INFORMATION: The 

Department of Justice published its 

revised final regulations implementing 

the Americans with Disabilities Act 

(ADA) for title II (State and local 

government services) and title III (public 

accommodations and commercial 

facilities) on September 15, 2010. See 75 

FR 56163. The revised ADA rules were 

the result of a six-year process to update 

the Department’s regulations. As part of 

this process, the Department sought 

extensive public comment, issuing an 

Advance Notice of Proposed 

Rulemaking (ANPRM) on September 30, 

2004, 69 FR 58768, and two Notices of 

Proposed Rulemaking (NPRM) on June 

17, 2008, 73 FR 34466 (title II), and 73 

FR 34508 (title III). The Department also 

held a public hearing on the NPRMs and 

received over 4,435 written public 

comments. On September 15, 2010, the 

Department published a final rule 

revising the regulations implementing 

titles II and III of the ADA. As part of 

this revision, the Department adopted 

the 2010 ADA Standards for Accessible 


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