[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Rules and Regulations]
[Pages 4087-4091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1361]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 90N-0376]
RIN 0905-AA73


Current Good Manufacturing Practice in Manufacturing, Processing, 
Packing, or Holding of Drugs; Amendment of Certain Requirements for 
Finished Pharmaceuticals

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising certain 
requirements of the current good manufacturing practice (CGMP) 
regulations for finished human and veterinary pharmaceuticals. The 
changes include clarifying the degree of discretion provided to 
manufacturers to determine whether separate or defined areas of 
production and storage are necessary, clarifying the standard used to 
determine the degree of scrutiny necessary to check the accuracy of the 
input to and output from computer systems, exempting investigational 
new drug products from bearing an expiration date, permitting the use 
of a representative sampling plan for the examination of reserve 
samples, and clarifying the manufacturer's responsibilities regarding 
batch records during the annual evaluation of drug product quality 
standards. These revisions will reduce regulatory burdens.

EFFECTIVE DATE: February 21, 1995.

FOR FURTHER INFORMATION CONTACT:

    Howard P. Muller, Jr., Center for Drug Evaluation and Research 
(HFD-362), Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-594-1046,
    Paul J. Motise, Center for Drug Evaluation and Research (HFD-323), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
301-594-1089, or
    William G. Marnane, Center for Veterinary Medicine (HFV-143), Food 
and Drug Administration, 7500 Standish Pl., Rockville MD 20855, 301-
594-0678.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 14, 1981 (46 FR 36332), FDA 
announced that it was undertaking a review of existing regulations with 
the goal of minimizing regulatory burdens while maintaining an 
acceptable level of consumer protection. The public was invited to 
submit information to assist the agency in deciding the priority of 
review. FDA invited data that would enable the agency to identify 
specific existing regulations or groups of regulations perceived to be 
unnecessarily costly, burdensome, or without public benefit, and on the 
potential savings to be derived from revising or removing regulations.
    In the Federal Register of July 2, 1982 (47 FR 29004), FDA 
announced its review priorities based on comments from 125 individuals 
and organizations. One area selected for regulatory review was part 211 
(21 CFR part 211), the regulations that govern CGMP for finished 
pharmaceuticals.
    This, in turn, led to an internal retrospective review that 
resulted in recommendations to the agency. As a result of the agency 
review, in the Federal Register of February 12, 1991 (56 FR 5671), FDA 
issued a proposed rule incorporating the recommendations resulting from 
the review (hereinafter referred to as the proposed rule). 
Consideration of these comments and any resulting revisions have been 
incorporated into this final rule and are discussed in detail below.
    The agency's review of CGMP regulations is ongoing and FDA 
anticipates further revisions based on the agency's experience with the 
regulations, enforcement efforts, and communications with industry and 
the general public. [[Page 4088]] 

II. The Agency's Retrospective Review

    The agency conducted an internal retrospective review (the review) 
of CGMP regulations to determine if any existing provisions should be 
changed, modified, or removed. Based on that review, the agency 
concluded that there was a continuing need for the CGMP regulations to 
protect public health and safety. FDA's examination of individual CGMP 
provisions revealed that most were necessary and effective in 
addressing the underlying issues and concerns. The review did, however, 
result in recommended changes in particular CGMP regulations. These 
changes were intended to provide drug manufacturers with more 
flexibility and discretion in manufacturing drug products while 
maintaining the manufacturing control necessary to ensure drug product 
quality. The proposed changes are discussed below.
    Section 211.42(c) requires separate or defined areas for a firm's 
operation to prevent contamination or a mixup of drug products or their 
ingredients. Although the agency's review found that, in general, this 
provision did not, with the exception of areas of aseptic processing or 
penicillin production, require the construction of physical barriers, 
FDA recognized that the word ``defined'' might be subject to differing 
interpretations. FDA concluded that amending this provision would 
clarify that, in most cases, manufacturers may exercise their judgment 
to determine whether separate or defined areas of production and 
storage are necessary. The agency is currently evaluating the matter of 
separate or defined areas of production and storage and may, if 
necessary, issue further clarification in the future.
    Several CGMP regulations require that manufacturers take steps to 
check the accuracy of equipment used in drug production. For example, 
Sec. 211.68(b) addresses the accuracy of computerized records and data. 
A number of comments opposed routine checking of the accuracy of input 
to or output from a previously validated computer on the basis that it 
was duplicative, redundant, and expensive. FDA reviewed these comments 
and concluded that, although automated systems may be less prone to 
error, such systems are not perfect and need to be monitored. Following 
its review, however, FDA agreed that the degree of monitoring required 
for computerized systems would differ from that required for manual 
operations. FDA concluded that this provision of the CGMP regulations 
should be revised to clarify that the degree and frequency of input/
output verification be based on the complexity and reliability of the 
computer or related system.
    Before its retrospective review of the CGMP regulations, FDA 
declined to grant investigational drug products an unqualified 
exemption from all or most of the CGMP requirements. Following the 
retrospective review, however, FDA concluded that it was not always 
possible to obtain expiration dates for investigational drug products 
because relatively little stability data may be available at the 
beginning of a clinical investigation. FDA concluded that the 
expiration dating requirement should be eliminated for investigational 
new drug application (IND) products so long as such products otherwise 
meet the stability requirements provided in the regulation.
    Section 211.170(b) requires that most reserve samples be examined 
visually at least once a year for evidence of deterioration. 
Manufacturers must keep reserve samples that are representative of each 
lot or batch of finished drug product. The reserve sample is to consist 
of at least twice the quantity necessary for all required tests. 
Comments responding to the July 14, 1981, notice, as well as other 
communications subsequently received by the agency, recommended 
deleting this requirement because of the large cost to firms that 
produce large numbers of lots (or batches) of a drug product. The 
comments further asserted that this requirement was redundant given 
other provisions of the regulations.
    FDA declines to eliminate this requirement because suggested 
alternatives do not provide effective surveillance of all lots of a 
drug product. The agency believes the yearly inspection is necessary to 
ensure the quality of the drug product. However, following the 
retrospective review, FDA concluded that manufacturers could meet their 
obligations under this regulation in a less burdensome way by 
conducting an annual visual inspection of reserve samples from a 
representative number of reserve sample lots. Therefore, FDA is 
revising the regulation to permit the use of a representative sampling 
plan for examination of reserve samples.
    Section 211.180 provides general requirements for the retention, 
treatment, and handling of CGMP records and reports. Section 211.180(e) 
requires the evaluation, at least annually, of the quality standards of 
each drug to determine the need for changes in drug product 
specifications. Firms must establish and follow written procedures for 
these annual evaluations, and Sec. 211.180(e)(1) and (e)(2) requires 
that several specific items be included in such written procedures. For 
example, Sec. 211.180(e)(1) requires these written procedures to 
provide for ``[a] review of every batch, whether approved or rejected, 
and, where applicable, records associated with the batch.''
    Following the retrospective review, FDA concluded that some 
manufacturers, rather than examining representative batch records for 
each drug product manufactured during the year, construed this 
provision to require that every batch record was to be reviewed 
annually and evaluated according to written procedures. Following the 
retrospective review, FDA decided to clarify Sec. 211.180(e)(1) on this 
point.

III. Comments on the Proposed Rule

    FDA received several comments on the proposed rule. These comments 
came from pharmaceutical manufacturers, trade associations, and 
consumers. In general, the comments supported the agency's efforts to 
remove, where possible, regulatory requirements that could be 
eliminated without adversely affecting drug product quality. A section-
by-section summary of the comments and the agency's response follow.

A. Design and Construction Features

    Confusion about the interpretation of Sec. 211.42(c), which 
requires separate or defined areas for a firm's operation to prevent 
contamination or mixup, led to the proposed revision of this provision. 
The proposed revision was intended to clarify that, in many situations, 
other control systems may be used in lieu of complete physical 
separation. The proposal would require separate or defined areas to 
prevent contamination or mixup ``as necessary.''
    1. Comments on proposed Sec. 211.42 generally supported the 
revision. Three comments, however, recommended that the wording be 
modified. One comment requested that the revision more explicitly 
emphasize that the utilization of computer-controlled inventory systems 
obviates the need for physical separation. Two comments suggested 
removal of any reference to separate or defined areas.
    The agency agrees in part and disagrees in part with these 
comments. The preamble to the proposed rule noted that Sec. 211.42(c) 
is intended to ensure that sufficient physical separation exists in 
manufacturing operations to prevent contamination or mixups, and that 
the degree of separation is dependent on the type of operation and its 
proximity to other operations in the plant (56 FR 5671 at 
[[Page 4089]] 5672). The proposed revision was intended to make it 
clear that the regulation did not necessarily require a separate room 
or partitioned area. The agency does not, however, intend to disallow 
the possibility that, in certain instances, it may be necessary to 
require physical separation to prevent contamination or mixups and, as 
discussed above, is continuing to review this matter. Sophisticated 
computer systems may provide more effective inventory control and help 
reduce mixups, but certain substances, such as penicillin, may pose 
such a high risk of contamination that a separate or defined area is 
necessary to ensure the safety of drug products.
    The agency has, therefore, retained the reference to separate or 
defined areas but has revised the final rule to clarify that other 
control systems may be used that are capable of preventing 
contamination and mixups. The agency stated in the preamble to the CGMP 
regulations published in the Federal Register of September 29, 1978 (43 
FR 45014 at 45037), and reiterated in the proposed rule (56 FR 5671 at 
5672 and 5673), and states again here that this provision is intended 
to ensure that: ``enough physical separation be employed as is 
necessary to prevent contamination or mixups. The degree of separation 
will depend on the type of operation and its proximity to other 
operations within the plant. The phrase `separate or defined' is not 
intended necessarily to mean a separate room or partitioned area, if 
other controls are adequate to prevent mixups and contamination.''
    The agency, on its own initiative, has also revised Sec. 211.42 to 
clarify that the procedures in paragraphs (c)(1) through (c)(10) of 
that regulation should be protected from contamination or mixups.

B. Automatic, Mechanical, and Electronic Equipment

    Section 211.68(b) deals with controls to be exercised over computer 
operation, data, and records. The provision requires, in part, that 
input to and output from a computer system or any related or similar 
system of formulas or data shall be checked for accuracy. The proposal 
would add a sentence stating that the degree and frequency of input/
output verification from a computer or related system of formulas or 
other records or data are to be determined by the complexity and 
reliability of such a computer or related system.
    2. Although all comments supported the proposed change to 
Sec. 211.68(b), three of them would modify the wording. The comments 
suggested that the revised regulation does not accommodate the accepted 
use of validated computerized drug production and control systems.
    FDA declines to amend the rule as suggested by the comments. The 
agency believes that the wording in the revised rule adequately 
encompasses the use of validated computerized drug production and 
control systems.
    3. Two comments questioned the need for human verification of 
operations that are performed by validated computer systems. Both 
listed other regulations that were not the subject of the proposed rule 
that required more than one person to verify certain manufacturing 
operations, apparently in an effort to show that additional personnel 
would be needed to comply with proposed Sec. 211.68.
    FDA notes that the revisions to Sec. 211.68 do not impose any 
specific personnel requirements. The agency, however, is aware that 
computers are subject to malfunctions; for example, the abrupt loss of 
data due to a computer ``crash'' can be a disruptive experience and 
possibly result in the loss of crucial information regarding the 
manufacturing process. Less dramatic events, such as faulty data entry 
or programming, can also trigger a chain of events that result in a 
serious production error and the possible distribution of an 
adulterated product. Thus, while increasingly sophisticated system 
safeguards and computerized monitoring of essential equipment and 
programs help protect data, no automated system exists that can 
completely substitute for human oversight and supervision.
    The proposed rule stated (56 FR 5671 at 5673), and FDA reiterates 
here, that while the degree of verification is left to the 
manufacturer's discretion, the exercise of such discretion, under 
Sec. 211.68, requires the use of routine accuracy checks to provide a 
high degree of assurance that input to and output from a computer or 
related system are reliable and accurate.
    The agency intends that each manufacturer will exercise reasonable 
judgment based on a variety of factors, including, but not limited to, 
the complexity of the computer or related system, in developing a 
method to prevent inaccurate data input and output.

C. Expiration Dating

    Proposed Sec. 211.137(g) would exempt investigational drug products 
from expiration dating requirements provided appropriate stability 
studies demonstrate that such products meet appropriate standards or 
specifications during their use in clinical investigations.
    4. All comments supported the proposed revision of Sec. 211.137. 
Two comments, however, recommended changes to clarify the labeling 
requirements for new drug products for investigational use that are to 
be reconstituted at the time of dispensing. One comment suggested 
language specifying the requirement's application to new drug products 
for investigational use to avoid confusion with Sec. 211.137(c), which 
applies to all drug products that are to be reconstituted at the time 
of dispensing.
    The agency agrees with these comments and has revised the rule 
accordingly.
    5. Proposed Sec. 211.137(g) also deals with new drug products for 
investigational use that are to be reconstituted at the time of 
dispensing. The proposed regulation stated that labeling of such 
products would be required to bear expiration ``dating'' for the 
reconstituted drug product. One comment suggested changing the proposed 
requirement instead to require the labeling to bear expiration 
``information'' for reconstituted drug products.
    The requirement that expiration ``information'' be placed in the 
labeling of a drug product is found at Sec. 211.137(c), and FDA agrees 
that this requirement should also apply to Sec. 211.137(g). The final 
rule has been revised accordingly.
    6. One comment recommended that the proposed exemption be extended 
to other clinical supplies not subject to IND requirements that are 
distributed for limited clinical testing, such as internal testing or 
evaluation in laboratories or for market research. Examples cited 
included drugs subject to over-the-counter drug monographs or Drug 
Efficacy Study Implementation requirements.
    The agency does not agree that clinical supplies not subject to IND 
requirements should be exempt from expiration dating. The revision 
recognizes that for IND products it is often difficult or impossible to 
obtain the data upon which expiration dates are based. IND products 
are, therefore, exempt from expiration dating requirements provided 
that they meet appropriate standards or specifications as demonstrated 
by stability studies during their use in clinical investigations.

D. Reserve Samples

    As previously noted, proposed Sec. 211.170(b) would clarify FDA's 
intent [[Page 4090]] that this provision requires visual examination of 
reserve samples from representative sample lots or batches of a drug 
product once a year for evidence of deterioration unless such 
examination would affect the integrity of the reserve sample. The 
representative sample lots or batches would be selected by acceptable 
statistical procedures.
    7. Although most comments agreed with the proposed change, several 
questioned the value of the annual visual examination requirement given 
other required procedures and programs such as stability testing, 
production record reviews, and complaint investigations.
    The agency has carefully considered these comments and has 
concluded that the requirement for annual visual inspection should be 
retained. A sufficient number of batches may not be examined during the 
course of fulfilling the other required procedures and programs, or 
batches examined may not be representative of annual batch production. 
As a result, these other procedures and programs cannot replace the 
annual visual examination, which provides both manufacturers and 
consumers a greater degree of quality assurance.
    8. Three comments requested clarification of the terms 
``representative'' and ``acceptable statistical procedures.''
    The agency does not believe that it is necessary or useful to 
define these terms. The terms have been used in the CGMP regulations 
for over a decade without apparent confusion due, in part, to a 
widespread recognition that the meaning of the term ``representative'' 
may vary from one product to another as well as with respect to the 
various manufacturing processes involved in producing a variety of 
products. In addition, an incomplete definition might fail to encompass 
the full variety of regulated products and processes, whereas a 
complete and inclusive definition with regard to currently available 
products and technology might not easily be adapted to new technology. 
Similarly, with respect to the term ``acceptable statistical 
procedures,'' a more detailed definition would not permit adaptation to 
or evolution with advances in statistical analysis.
    9. Another comment suggested that the phrase ``acceptable 
statistical procedures'' could be interpreted to require FDA approval. 
The comment suggested that the term be changed to ``appropriate 
statistical procedures.''
    As noted above, the agency does not believe that the suggested 
change is necessary or useful. The agency emphasizes that the selection 
of acceptable statistical procedures does not involve prior agency 
approval. The choice of such procedures should, however, be based on a 
knowledge of current statistical methodology and include consideration 
of the application of such methodology to a particular drug product.

E. General Requirements

    Section 211.180(e) requires that written records be maintained so 
that the data contained therein are available at least annually for 
evaluation of the quality standards for drug products. Proposed 
Sec. 211.180(e)(1) was intended to correct the misinterpretation that 
the regulation required the review of every batch record for every drug 
product produced during the year. The proposed rule revised the 
language to require at least annually a review of a representative 
number of batch records.
    10. One comment noted that current technology makes it possible to 
use computer data to evaluate product quality data to detect adverse 
trends. The comment asserted that such an approach permitted more 
effective and frequent evaluation of such data.
    The agency agrees that technological advances can produce gains in 
both the accuracy of data evaluation and the speed at which the process 
can be conducted, and FDA encourages the use of technology that helps 
safeguard the integrity of the manufacturing process. However, such 
computerized information must be used as a complement to, and not as a 
substitute for, human judgment and intervention. Computerized 
assessments must be monitored by qualified individuals to detect trends 
that may provide an early indication of changes in drug product 
specifications or manufacturing or control procedures that merit 
attention and intervention. Moreover, other factors such as product 
complaints and recall information may not be included in the computer 
data.
    11. Several comments requested clarification about the types of 
records subject to the batch review requirement.
    The proposed rule was not intended to change the types of records 
subject to annual review, but instead to allow review of a 
representative number of batches in lieu of examining all records from 
every batch. FDA has, therefore, clarified the final rule to require a 
review of a representative number of batches, whether approved or 
rejected, and where applicable, records associated with those batches.
    The overall intent of Sec. 211.180(e) is to provide manufacturers 
with reliable procedures for reviewing the quality standards for each 
drug product. Thus, FDA advises that, although this final rule does not 
in all cases require an annual review of every batch record, adopting a 
procedure to check every batch record would clearly be appropriate if, 
for example, a representative review of batch records showed an adverse 
trend in quality.
    12. One comment advised that some firms may confuse the 
requirements with regard to the annual review of representative batches 
with the requirements for batch review prior to the release of a 
product under Sec. 211.192.
    FDA disagrees with the comment. The final rule amends 
Sec. 211.180(e), which requires that written records be maintained so 
that data can be used for evaluating, at least annually, the quality 
standards of each drug product. Section 211.192, by contrast, 
specifically requires a quality control unit to review drug product 
production and control records to determine compliance with written 
procedures prior to the release of a drug product batch. In brief, 
Sec. 211.180(e) involves a retrospective overall evaluation of the 
adequacy of the quality standards for drug products, while Sec. 211.192 
involves a contemporaneous evaluation of a drug batch to determine its 
conformity, at the time of marketing, with current quality standards.
    13. One comment suggested allowing a biennial review to permit 
trend analysis when three or fewer product batches are produced each 
year.
    FDA disagrees with this comment. The agency believes that a 2-year 
interval between formal review of batches is inadequate. Potential 
problems with product quality standards could go undetected and thereby 
delay recognition of a need to revise specifications or manufacturing 
or control procedures. If a serious error is not detected for a long 
period, the resulting product could pose a threat to public health and 
safety. Moreover, a trend analysis may be performed in situations where 
only a few batches are produced annually by using batches produced in 
preceding years.
    14. One comment strongly opposed the proposed changes, stating that 
every batch record must be reviewed to detect ``drift'' or changes in 
specifications for components, manufacturing processes, or other 
procedures. The comment asserted that, without reviewing every batch, 
deleterious changes might be instituted by a firm employee or employees 
without the full knowledge of their superiors, particularly the firm's 
research and development group. [[Page 4091]] 
    The agency does not believe such additional measures are necessary. 
This CGMP provision does not stand alone but must be read in context 
with other CGMP regulations. Those regulations provide a variety of 
safeguards for different stages and aspects of the drug manufacturing 
process. It is the CGMP regulations, taken as a whole, that help ensure 
drug quality. Moreover, the consequences of widespread disclosure of 
problems with drug product quality resulting from a recall or other 
ameliorative action are sufficiently severe to provide most firms with 
a continuing incentive to maintain product quality. The agency has 
carefully reviewed this issue and believes that the final rule will not 
reduce drug product quality.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(10) 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs 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 rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. The amendments to the CGMP 
regulations are intended to allow drug manufacturers more flexibility 
and discretion in manufacturing drug products while maintaining those 
CGMP requirements necessary to ensure drug product quality. Because 
this may encourage innovation and the development of more efficient 
manufacturing procedures that should lead to cost savings for drug 
manufacturers. In addition, the rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis 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: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 
355, 356, 357, 360b, 371, 374).

    2. Section 211.42 is amended in the introductory text of paragraph 
(c) by revising the second sentence to read as follows:

Sec. 211.42  Design and construction features.

* * * * *
    (c) * * * There shall be separate or defined areas or such other 
control systems for the firm's operations as are necessary to prevent 
contamination or mixups during the course of the following procedures:
* * * * *
    3. Section 211.68 is amended by adding a new sentence after the 
second sentence in paragraph (b) to read as follows:

Sec. 211.68  Automatic, mechanical, and electronic equipment.

* * * * *
    (b) * * * The degree and frequency of input/output verification 
shall be based on the complexity and reliability of the computer or 
related system. * * *
    4. Section 211.137 is amended by redesignating paragraph (g) as 
paragraph (h), and by adding new paragraph (g) to read as follows:

Sec. 211.137  Expiration dating.

* * * * *
    (g) New drug products for investigational use are exempt from the 
requirements of this section, provided that they meet appropriate 
standards or specifications as demonstrated by stability studies during 
their use in clinical investigations. Where new drug products for 
investigational use are to be reconstituted at the time of dispensing, 
their labeling shall bear expiration information for the reconstituted 
drug product.
* * * * *
    5. Section 211.170 is amended by revising the fourth sentence in 
the introductory text of paragraph (b) to read as follows:

Sec. 211.170  Reserve samples.

* * * * *
    (b) * * * Except for those for drug products described in paragraph 
(b)(2) of this section, reserve samples from representative sample lots 
or batches selected by acceptable statistical procedures shall be 
examined visually at least once a year for evidence of deterioration 
unless visual examination would affect the integrity of the reserve 
sample. * * *
* * * * *
    6. Section 211.180 is amended by revising paragraph (e)(1) to read 
as follows:

Sec. 211.180  General requirements.

* * * * *
    (e) * * *
    (1) A review of a representative number of batches, whether 
approved or rejected, and, where applicable, records associated with 
the batch.
* * * * *

    Dated: January 11, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-1361 Filed 1-19-95; 8:45 am]
BILLING CODE 4160-01-F