[Federal Register: July 2, 2004 (Volume 69, Number 127)]
[Rules and Regulations]
[Page 40481-40511]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy04-14]
[[Page 40481]]
-----------------------------------------------------------------------
Part III
Federal Trade Commission
-----------------------------------------------------------------------
16 CFR Parts 315 and 456
Contact Lens Rule; Final Rule
[[Page 40482]]
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
16 CFR Parts 315 and 456
RIN 3084-AA95
Contact Lens Rule
AGENCY: Federal Trade Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: In this document, the Federal Trade Commission (the
``Commission'') issues a Final Rule implementing the Fairness to
Contact Lens Consumers Act (the ``Act''), 15 U.S.C. 7601 et seq., which
provides for the availability of contact lens prescriptions to patients
and the verification of contact lens prescriptions by prescribers. This
document also implements two clerical amendments to the Commission's
Ophthalmic Practices Rules to clarify the distinction between those
Ophthalmic Practices Rules and the Contact Lens Rule.
DATES: Effective Date: The Rule will become effective on August 2,
2004.
ADDRESSES: Requests for copies of the Rule and the Statement of Basis
and Purpose should be sent to the Commission's Public Reference Branch,
Room 130, Federal Trade Commission, 600 Pennsylvania Avenue, NW.,
Washington, DC 20580. The complete record of this proceeding is also
available at that address. Relevant portions of the proceeding,
including the Rule and Statement of Basis and Purpose, are also
available at the Commission's Web site, http://www.ftc.gov.
FOR FURTHER INFORMATION CONTACT: Division of Advertising Practices,
Thomas Pahl or Char Pagar [(202) 326-3528], Federal Trade Commission,
Bureau of Consumer Protection, Division of Advertising Practices, 600
Pennsylvania Avenue, NW., Washington, DC 20580.
SUPPLEMENTARY INFORMATION: The Contact Lens Rule (``the Rule'')
implements the requirements of the Fairness to Contact Lens Consumers
Act (``the Act''), 15 U.S.C. 7601-7610. Specifically, the Rule: (1)
Requires prescribers (such as optometrists and ophthalmologists) to
provide patients with a copy of their contact lens prescription
immediately upon completion of a contact lens fitting; (2) requires
prescribers to provide or verify contact lens prescriptions to any
third party designated by a patient; (3) prohibits prescribers from
placing certain conditions on the release or verification of a contact
lens prescription; (4) limits the circumstances under which a provider
can require payment for an eye exam prior to releasing a contact lens
prescription to a patient; (5) requires contact lens sellers to either
obtain a copy of a patient's prescription or verify the prescription
before selling contact lenses; (6) addresses the issue of private label
contact lenses; (7) sets minimum expiration dates for contact lens
prescriptions; (8) prohibits representations that contact lenses may be
obtained without a prescription; (9) prohibits prescribers from using
or requiring patients to sign any waiver or disclaimer of liability for
the accuracy of an eye examination; (10) defines relevant terms; (11)
establishes that violations of the proposed Rule will be treated as
violations of a rule defining an unfair or deceptive act or practice
under section 18 of the Federal Trade Commission Act; and (12) provides
that State and local laws and regulations are preempted under certain
circumstances.
Statement of Basis and Purpose
I. Introduction
On December 6, 2003, President Bush signed the Act into law.\1\
Among other things, the Act requires that prescribers, including
optometrists and ophthalmologists, provide contact lens prescriptions
to their patients upon the completion of a contact lens fitting.\2\ The
Act also mandates that prescribers verify contact lens prescriptions to
third-party contact lens sellers who are authorized by consumers to
seek such verification.\3\ The Act directs the Commission to prescribe
implementing rules.\4\ Any violation of the Act or its implementing
rules constitutes a violation of a rule under Section 18 of the Federal
Trade Commission Act, 15 U.S.C. 57a, regarding unfair or deceptive acts
or practices.\5\ The Act authorizes the Commission to investigate and
enforce the Act in the same manner, by the same means, and with the
same jurisdiction, powers, and duties, as a trade regulation rule under
the Federal Trade Commission Act.\6\
---------------------------------------------------------------------------
\1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
\2\ Id. at 7601.
\3\ Id. at 7601, 7603.
\4\ Id. at 7607.
\5\ Id. at 7608.
\6\ Id.
---------------------------------------------------------------------------
The Commission published a Notice of Proposed Rulemaking and
Request for Public Comment (``NPRM'') in the Federal Register on
February 4, 2004,\7\ and the 60-day comment period closed on April 5,
2004. The Commission received more than 7,000 comments. The commenters
included nearly 6,000 individual consumers as well as prescribers,
their State and national trade associations, contact lens sellers,
State attorneys general, and others. Based on the rulemaking record,
including the comments received, the Commission has modified the
proposed Rule published in the NPRM and now promulgates a final rule as
described in this Statement of Basis and Purpose.
---------------------------------------------------------------------------
\7\ 69 FR 5440 (Feb. 4, 2004).
---------------------------------------------------------------------------
In addition, the Commission enforces the Ophthalmic Practice
Rules,\8\ which primarily require the release of eyeglass prescriptions
to patients at the completion of an eye examination, and prohibit eye
care practitioners from placing certain conditions on such release. The
Commission today implements two clerical amendments, set forth in
section III below, to clarify the relationship between the Ophthalmic
Practices Rules and the Contact Lens Rule.
---------------------------------------------------------------------------
\8\ 16 CFR part 456.
---------------------------------------------------------------------------
II. The Rule
As noted above, the Commission published the proposed rule and
accompanying analysis in the Federal Register on February 4, 2004.\9\
Unless specifically modified herein, all of the analysis accompanying
the proposed rule in the NPRM is adopted and incorporated into this
Statement of Basis and Purpose for the final rule.
---------------------------------------------------------------------------
\9\ 69 FR 5440 (Feb. 4, 2004).
---------------------------------------------------------------------------
A. Section 315.1: Scope of Regulations
Section 315.1 of the proposed Rule described the basis for, and the
general scope of, the regulations in part 315--the ``Contact Lens
Rule''--which implements the Fairness to Contact Lens Consumers Act.
The Commission received no comments on this provision and adopts it
without modification.
B. Section 315.2: Definitions
1. Definition of ``Business Hour''
Congress recognized that consumers may be harmed if they face undue
delays in receiving their contact lenses from a seller. Congress also
acknowledged that consumers may be harmed if a seller provides contact
lenses to a consumer based on an expired, inaccurate, or otherwise
invalid prescription. Congress balanced these considerations in section
4(d)(3) of the Act by allowing a seller to treat a prescription as
``verified'' and sell contact lenses to a consumer if a prescriber has
not notified the seller ``within eight (8) business hours, or a similar
time as defined by the Commission,'' that a prescription is expired,
inaccurate, or otherwise invalid.\10\
---------------------------------------------------------------------------
\10\ 15 U.S.C. 7603(d)(3).
---------------------------------------------------------------------------
[[Page 40483]]
The Act does not define ``business hour'' or set forth how to
calculate ``eight business hours.'' The purpose of the verification
period established under the Act, however, is to give prescribers an
opportunity to determine whether prescriptions are expired, inaccurate,
or otherwise invalid. Because prescribers make this determination
during the hours that they are open, Congress apparently intended
prescribers to have eight hours during which they are open for business
to respond to a verification request.
Accordingly, in the proposed Rule, the Commission defined
``business hour'' as an hour between 9 a.m. and 5 p.m., during a
weekday excluding Federal holidays. The definition further specified
that for verification requests received between 9 a.m. and 5 p.m.,
``eight (8) business hours'' would be calculated from the first
business hour that occurs after the seller provides the prescription
verification request to the prescriber, and conclude after eight
business hours have elapsed. For verification requests received by a
prescriber during non-business hours, the calculation of eight business
hours would begin at 9 a.m. on the next weekday that is not a Federal
holiday, and would end at 9 a.m. on the following weekday.
For the reasons discussed below, the Commission retains the
definition of ``business hour'' as an hour between 9 a.m. and 5 p.m.,
during a non-holiday weekday. However, the Commission has revised the
rule to provide sellers with the option of counting a prescriber's
regular business hours on Saturdays, so long as the seller has actual
knowledge of these hours. In addition, the Commission has revised the
calculation of ``eight (8) business hours'' so that the verification
period ends--and a seller may sell contact lenses--as soon as eight
business hours have elapsed. Finally, the Commission clarifies that
business hours are to be determined based on the time zone of the
prescriber.
a. Actual Hours
The Commission's proposed definition of ``business hour'' generated
a substantial number of public comments. A number of comments sought a
definition that reflects prescribers' actual business hours. For
example, one large Internet-based contact lens seller urged that
sellers should have the option of determining the actual business hours
of a particular prescriber and using those as an alternative to the
Rule's ``default'' business hours.\11\
---------------------------------------------------------------------------
\11\ 1-800 CONTACTS (Comment 1140). The Mercatus Center
at George Mason University (Regulatory Studies Program) (Comment
1087) made a similar proposal.
---------------------------------------------------------------------------
A number of prescribers and their trade associations also sought a
definition of ``business hours'' that reflects actual business hours.
These commenters, however, explained that the Commission's proposed
definition did not take into account days when a prescriber's office is
closed and the prescriber cannot respond to a verification request
within eight business hours. These commenters sought various exceptions
or extensions to the business hour definition to accommodate
circumstances such as days the prescriber's office is regularly closed;
days the prescriber is performing surgery; and days a prescriber is out
of the office for continuing education, illness, vacation, or inclement
weather.\12\ Many commenters also sought an exception for so-called
``satellite offices,'' described as prescriber offices commonly located
in rural areas and open only one or two days per week.\13\ Other
commenters emphasized generally that actual prescriber business hours
vary from those of other retail and Internet businesses, and urged the
Commission to craft a rule that ``serves the best interests and safety
of the consumers, not just those of contact lens sellers.'' \14\
---------------------------------------------------------------------------
\12\ E.g., American Optometric Association (Comment
1149) (citing continuing education, vacation and illness);
American Academy of Ophthalmology (Comment 1057) (9-5
Monday through Friday does not address realities of ophthalmologic
practice; approximately 40% of its members are solo practitioners;
Rule should make exceptions for surgery days, continuing education,
a weekday when the office is regularly closed, State or religious
holidays, solo practitioner illness and/or vacation days, and for
local, State, or federally mandated jury duty); New Jersey Academy
of Ophthalmology (Comment 1126) (most physicians are closed
one day per week and close for vacation several weeks per year;
requiring coverage from 9-5 every Monday through Friday is
unrealistic and unduly burdensome); Nebraska Optometric Association
(Comment 1083) (seeking ``reasonable extensions'' of eight-
hour rule when doctor is absent for continuing education, vacation,
or illness); Ohio Optometric Association (Comment 1151)
(same, citing continuing education obligations, illness, vacation,
periods of unplanned practice interruptions); New Mexico Optometric
Association (Comment 1081) (continuing education, vacation
and illness); C. Lesko, M.D., FACS (Comment 960) (performs
surgery two days a week); Kansas Optometric Association (Comment
1153) (citing continuing education (24 hours per year in
Kansas), vacation and illness); American Society of Cataract and
Refractive Surgery (Comment 1148); E. Lamp, O.D. (Comment
714).
\13\ E.g., Kansas Optometric Association (Comment 1153)
(citing approximately 60 satellite offices in State); Kentucky
Optometric Association (Comment 1101); Colorado Optometric
Association (Comment 1067); American Optometric Association
(Comment 1149); Nebraska Optometric Association (Comment
1083) (seeking ``reasonable extension'' of eight-hour rule
for verifications sent to satellite offices); Pennsylvania
Optometric Association (Comment 959); Ohio Optometric
Association (Comment 1151); New Mexico Optometric
Association (Comment 1081); B.L.Whitesell, O.D. (Comment
1115); S. Wagner, M.D. (Comment 928). A number of
these commenters explained that the records for patients of
satellite offices are often kept at the satellite office and thus,
on days the office is not open, are not readily accessible for
verification during an eight-hour window.
\14\ A.L. Warner (Comment 706).
---------------------------------------------------------------------------
Few of the voluminous comments received on this issue proposed a
means of accommodating the requested exceptions. Some suggested
providing a longer verification period generally,\15\ while others
suggested that the prescriber's office be permitted to inform the
seller of the prescriber's return date, or the date on which the office
would next be open, at which time the eight business hour verification
period would commence.\16\ One commenter suggested that, prior to
requesting verification, a seller should first have to determine that
the prescriber's office is open and that the prescriber will be present
in the office during the next eight hours.\17\
---------------------------------------------------------------------------
\15\ E.g., Texas Ophthalmological Association (Comment
1117).
\16\ E.g., American Optometric Association (Comment
1149); Ohio Optometric Association (Comment
1151); American Society of Cataract and Refractive Surgery (Comment
1148) (prescriber could be required to leave information on
answering service, voicemail, or answering machine); B.L. Whitesell,
O.D. (Comment 1115) (willing to tell sellers what his hours
are); K. Driver, O.D. (Comment 273) (same); S. Wagner, M.D.
(Comment 928) (Rule should allow prescriber to respond
within eight hours to a faxed request to a satellite office,
providing a specific statement that the records are in a remote
location and will be available for review on a certain date). See
also Pennsylvania Optometric Association (Comment 959)
(stating some of its members have contacted seller and asked them to
fax verification request to the main office but seller refused).
\17\ Tupelo Eye Clinic/Chappell (Comment 11). Other
commenters made similar suggestions. E.g., New Jersey Academy of
Ophthalmology (Comment 1126) (suggesting physicians be
permitted extra time beyond the eight business hours to comply, or
exempting from liability physicians who could not verify a
prescription due to office closure); Your Family Eye Doctors, Inc.
(Comment 705) (recommending 24 business hours for
verification rather than eight, to accommodate satellite offices);
G. Lozada (Comment 1063) and Opticians Association of Ohio
(Comment 1156) (also suggesting 24 hours); American Academy
of Ophthalmology (Comment 1057) (suggesting time period for
verification begin at 9:00 a.m. on the next business weekday that
the office is open).
---------------------------------------------------------------------------
Having considered these comments, the Commission declines to adopt
an actual hours or other prescriber-specific approach to business
hours. Evidence in the record indicates that there are more than 50,000
prescribers in the United
[[Page 40484]]
States,\18\ and that actual business hours vary widely among them.\19\
It likely would be difficult and burdensome--perhaps impossible--for
some sellers to determine and keep track of the actual hours of 50,000
prescribers.\20\ By contrast, a general rule using a uniform definition
of business hours for all prescribers provides clarity and relative
ease of compliance and enforcement. Moreover, there does not appear to
be any practical way to accommodate the myriad circumstances during
which the offices of 50,000 individual prescribers may be closed or
otherwise not able to respond to a prescription verification
request.\21\
---------------------------------------------------------------------------
\18\ See, e.g., American Optometric Association (Comment
1137) (representing some 33,000 members). In addition, the
American Academy of Ophthalmology has represented to Commission
staff that it represents approximately 17,000 members.
\19\ See, e.g., comments discussed supra; 1-800 CONTACTS
(Comment 1140) at attachment 32 (survey of prescribers'
actual hours).
\20\ Cf. AC Lens (Comment 974) (arguing that Rule
should not exclude State or local holidays as business days because
doing so would put unreasonable burden on smaller entities in other
States that have no practical way to track down such holidays in all
50 States).
\21\ The suggestion that a prescriber's staff be permitted to
contact the seller and inform them of the prescriber's absence--and
thereby obtain an extension to the eight hour verification period--
is simply not practical. Such a system would work only if
prescribers' offices were staffed on the relevant day, and the
public comments made clear that in many cases the office is simply
closed--e.g., because it is a satellite office, the office is
regularly closed on a certain weekday, or due to inclement weather.
---------------------------------------------------------------------------
In addition, several commenters, including optometric associations
and one State board, voiced support for the proposed definition,
particularly its limitation to weekdays and non-holidays.\22\ One
commenter stated that ``it would be impractical for the Commission to
craft store- or prescriber-specific rules.'' \23\ Similarly, other
commenters opposed exceptions or extensions for days a prescriber's
office may be closed for vacation, State or local holidays, or other
reasons. These commenters argued that making such exceptions would
impose undue burdens on small sellers to keep track of such closures,
thereby harming their ability to compete with larger sellers. These
commenters also argued that it would unreasonably delay delivery of
contact lenses to consumers.\24\
---------------------------------------------------------------------------
\22\ E.g., Florida Board of Optometry (Comment 1100);
National Association of Optometrists and Opticians (Comment
1146) (supporting limitation to weekdays and non-holidays);
American Optometric Association (Comment 1149) (supporting
proposed definition because it ``recognizes the fact that while some
offices are open on some Saturdays, most are not open every
Saturday, and many are not open any Saturday'').
\23\ National Association of Optometrists and Opticians (Comment
1146).
\24\ AC Lens (Comment 974); R.Weigner (Comment
1118) (information about State and local holidays is not
available to national mail order and internet firms; even if it were
available, it would be cost-prohibitive to implement and would
stifle competition).
---------------------------------------------------------------------------
b. General Rule
Having determined that a general rule using uniform business hours
is preferable to an actual hours standard, the Commission discusses
below the remaining comments received on its proposed definition and
the revisions the Commission has made to the Rule in response.
1. Monday Through Friday
A number of commenters offered alternative definitions of business
hours. A few commenters, including the California Board of Optometry,
urged the Commission to consider adopting a verification time period
that tracks California State law.\25\ Under California's prescription
release law, a prescription is verified if the prescriber does not
respond by or before the same time on the next business day after the
seller requested verification, or by 2 p.m. the next business day,
whichever is earlier.\26\
---------------------------------------------------------------------------
\25\ E.g., California Board of Optometry (Comment 21);
Hon. Jim Matheson, U.S. House of Rep. (Comment 1237); L.
Correa, California Assembly Rep. (Comment 1142); Citizens
for a Sound Economy (Comment 1108) (noting the California
law ``has been in place for over a year, and has worked well'');
William F. Shughart, II, Ph.D. (Comment 975) (on behalf of
1-800-CONTACTS).
\26\ California's statute took effect in January 2003, just over
one year before the Fairness to Contact Lens Consumers Act took
effect.
---------------------------------------------------------------------------
One contact lens seller, Wal-Mart, proposed a ``24-hour'' rule,
somewhat similar to California's, under which the verification period
would expire at the same time on the next business day after the
prescriber received the verification request.\27\
---------------------------------------------------------------------------
\27\ Wal-Mart Optical Division (Comment 1070).
---------------------------------------------------------------------------
Another seller, 1-800 CONTACTS, proposed defining ``business
hours'' as 9 a.m. to 6:30 p.m., Monday through Friday, and 9 a.m. to 4
p.m. on Saturday, based on a survey of actual prescriber business
hours.\28\ The survey itself concluded that a ``standardized work
week'' for optical goods retailers is 9 a.m. to 6:15 p.m. Monday
through Thursday, 9 a.m. to 6 p.m. Friday, and 9 a.m. to 4:15 p.m.
Saturday.\29\
---------------------------------------------------------------------------
\28\ 1-800 CONTACTS (Comment 1140). The survey,
submitted as part of the record in this proceeding, was prepared by
Synovate, a market research firm, and consisted of 300 telephone
interviews for each of four retail channels--independent
optometrists, ophthalmologists, optical retail chains (e.g.,
LensCrafters, Pearle Vision), and mass merchandisers (e.g., Wal-
Mart, Target, Costco)--asking about store business hours. See
Comment 1140, attachment 32. From the interview results,
average opening and closing times were determined for each day of
the week for each retail channel as follows:
Mass merchandisers: approximately 9:15 a.m. to 8:35 p.m. Monday
through Friday, Saturday 8:45 a.m. to 7:25 p.m., Sunday 11:25 a.m.
to 5:05 p.m.
Retail optical chains: approximately 9:45 a.m. to 7:25 p.m.
Monday through Thursday, Friday 9:40 a.m. to 7:15 p.m., Saturday
9:40 a.m. to 6:05 p.m., Sunday 11:35 a.m. to 5:15 p.m. (49% are
closed Sunday).
Independent optometrists: approximately 9 a.m. to 5:50 p.m.
Monday, Tuesday, Thursday, Wednesday 9 a.m. to 5:35 p.m., Friday
8:50 a.m. to 5:20 p.m., Saturday 9 a.m. to 2:40 p.m. (39% are closed
Saturday, 91% are closed Sunday).
Ophthalmologists: approximately 8:35 a.m. to 5:10 p.m. Monday
through Thursday, Friday 8:30 a.m. to 4:35 p.m., Saturday 8:40 a.m.
to 1:25 p.m. (75% are closed Saturday, 98% are closed Sunday).
[For purposes of simplicity, the Commission has rounded off some
of the averages set forth in the survey results to the closest 5-
minute increment.] Then, final average daily opening and closing
times--combining all four channels--were determined by weighting
each channel's average to match the actual incidence of lenses
dispensed among the four channels.
\29\ See Comment 1140, attachment 32.
---------------------------------------------------------------------------
Finally, a group of 34 State Attorneys General commented that the
proposed definition was too narrow because many prescribers are open
longer hours and on weekends.\30\ The Attorneys General offered three
alternatives, with a preference for a definition that would allow the
eight-hour verification period to end when the eight business hours
elapse, not at the start of the next business hour.\31\
---------------------------------------------------------------------------
\30\ State Attorneys General (Comment 1114). This
comment represented the views of the Attorneys General representing
Alabama, Arizona, California, Colorado, Connecticut, Delaware,
Hawaii, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Mississippi, Missouri, Nevada, New York, North Dakota,
Commonwealth of the Northern Mariana Islands, Ohio, Oklahoma,
Oregon, Rhode Island, South Carolina, South Dakota, Utah, Virginia,
Washington, West Virginia, Wisconsin, and Wyoming. The Attorney
General of Idaho filed a separate comment (Comment 1176)
joining the other States.
The Independent Women's Forum (Comment 1236) raised
many of the same arguments as the State Attorneys General, and
argued that the proposed definition of ``business hours'' would
``seriously undermine[] women's autonomy by reversing the
conveniences that have been created, in part, to support working
women and mothers.'' See also Hon. J. Sensenbrenner (Comment
1246) (arguing proposed definition ``bears no relation to
the way either consumers or retailers behave''); Progressive Policy
Institute (Comment 1141) (recommending broader definition
of business hour because eye care providers can sell contact lenses
to consumers any time they are open but would only have to verify
prescriptions between 9-5 on weekdays); Americans for Prosperity
(Comment 1145) (proposed definition is not grounded in
actual practices of the eye care industry).
\31\ The other alternatives were: (1) Using an ``actual hours''
standard under which sellers would be obligated to know the actual
business hours of each prescriber, and would be permitted to presume
verification (and ship an order) after the prescriber had received
the request and been open for eight business hours; and (2) allowing
sellers the option of using the 9 a.m. to 5 p.m. non-holiday weekday
definition or the actual prescriber business hours. See Comments
1114, 1176.
---------------------------------------------------------------------------
[[Page 40485]]
The Commission addresses the commenters' specific proposals in
detail below. However, having considered the comments, the Commission
has decided to retain the proposed definition of ``business hour'' as
an hour between 9 a.m. to 5 p.m. on a non-holiday weekday. Evidence in
the record clearly indicates that the 50,000 prescribers in the United
States vary as to their actual business hours--in some cases widely.
However, the Act clearly contemplates that prescribers should have a
reasonable opportunity when they are open to respond to verification
requests. The evidence indicates that most prescribers are open Monday
through Friday, and that most are open for at least eight hours per
day. Some appear to open earlier than 9 a.m., and some appear to be
open after 5 p.m., but a 9 a.m. to 5 p.m. rule generally should provide
these prescribers eight hours during which they are actually open to
respond to prescription verification requests.\32\ Moreover, such a
general rule should be easy for sellers and prescribers to apply,
because eight business hours would usually end at the exact same time
on the following business day. For example, if a verification request
is received at 2 p.m. on a Tuesday, the prescriber would have until 2
p.m. on Wednesday to respond.
---------------------------------------------------------------------------
\32\ The Commission notes that this rule has a similar practical
effect as the California model and the ``24-hour rule'' promoted by
a number of commenters. In many cases, the verification period will
expire at the same time, on the next business day, after the
prescriber receives the request, regardless of which model is
utilized. For example, a request received at 10 a.m. on a Tuesday
would be deemed verified at 10 a.m. on Wednesday under the
Commission's definition, the California model, or the 24-hour rule.
In some instances, the Commission's Rule will result in quicker
verification than under other proposed models; for requests received
prior to 9 a.m. on a Monday through Friday, the prescription will be
verified at 5 p.m. that same day rather than at 9 a.m. the following
business day under the California model or the 24-hour rule.
---------------------------------------------------------------------------
2. Saturday
Several commenters urged the Commission to include Saturday
business hours in the Rule's definition of ``business hours.'' \33\
Sellers argued that many prescribers are, in fact, open on Saturdays,
and that current retail operations in the United States typically
include Saturday business hours.\34\ The California Board of Optometry
noted that California's prescription release law recognizes Saturday as
a business day--``to accommodate the operational needs of contact lens
sellers''--and argued this model has proven successful.\35\
---------------------------------------------------------------------------
\33\ E.g., California Board of Optometry (Comment 21);
AC Lens (Comment 974); Costco Wholesale Corporation
(Comment 1061); 1-800 CONTACTS (Comment 1140);
Wal-Mart Optical Division (Comment 1070); Citizens for a
Sound Economy (Comment 1108).
\34\ E.g., 1-800 CONTACTS (Comment 1140); Costco
Wholesale Corporation (Comment 1061); See also Wal-Mart
(Comment 1070) (arguing that many working people can only
shop in the evening, and that ``contact lens prescribers should be
presumed to work normal business hours on days when most other
people work, whether or not they actually do so'').
\35\ California Board of Optometry (Comment 21). By
contrast, however, the California Optometric Association argued
against including Saturday business hours. See Comment
1158.
---------------------------------------------------------------------------
Other commenters, however, pointed out that many prescribers are
not open on Saturdays.\36\ The evidence in the record supports this
argument, indicating that a significant number of prescribers are not
regularly open on Saturdays. Survey data indicates that 39% of
optometrists and 75% of ophthalmologists are closed on Saturday,\37\
and that these groups issue a substantial majority of contact lens
prescriptions. This conclusion is generally consistent with the
estimates that some prescribers made in their comments.\38\
---------------------------------------------------------------------------
\36\ E.g., National Association of Optometrists and Opticians
(Comment 1146); American Optometric Association (Comment
1149).
\37\ See 1-800 CONTACTS (Comment 1140) at attachment
32.
\38\ National Association of Optometrists and Opticians (Comment
1146) (estimating more than half practitioners are not open
on Saturdays; supporting limitation to non-holiday weekdays);
American Optometric Association (Comment 1149) (supporting
proposed definition of business hours because it ``recognizes the
fact that while some offices are open on some Saturdays, most are
not open every Saturday, and many are not open any Saturday'').
---------------------------------------------------------------------------
Based on the comments and evidence, the Commission has revised the
Rule to give sellers the option of determining whether an individual
prescriber in fact has regular Saturday business hours, and, if so, to
include those hours in the eight-hour verification period prescribed in
section 315.5(c)(3). A rule requiring that Saturday hours be counted as
business hours would deny many prescribers who are not open a
reasonable opportunity to respond to prescription verification
requests. At the same time, not counting Saturdays at all would deny
consumers the opportunity to have their prescriptions verified by those
prescribers who are open, and to receive their lenses more quickly.
Because it may be burdensome for some sellers to obtain actual
knowledge of prescribers' Saturday business hours,\39\ the Commission
concludes that the Rule should provide sellers the option of counting
those hours, rather than requiring them to do so. This approach will
enable a consumer whose prescriber is open on Saturday, and who wants
to receive lenses as quickly as possible, to find a seller that will
determine the prescriber's Saturday hours. In addition, this approach
should be easy for prescribers to implement, because only those that
are open will have to respond to verification requests on Saturdays.
---------------------------------------------------------------------------
\39\ Cf. AC Lens (Comment 974) (arguing that Rule
should not exclude State or local holidays as business days because
doing so would put unreasonable burden on smaller entities in other
States that have no practical way to track down such holidays in all
50 States).
---------------------------------------------------------------------------
To facilitate the use of Saturday business hours, the final Rule
incorporates two related revisions to the proposed Rule. First, a
seller that exercises its option to count a prescriber's regular
Saturday business hours must state those hours clearly on the
verification request.\40\ This requirement will alert the prescriber
that the seller is in fact counting Saturday hours--so that the
prescriber can respond appropriately--and also provide an opportunity
for the prescriber to notify the seller if the seller uses the wrong
hours. Second, a seller exercising its option to count a prescriber's
regular Saturday business hours must maintain a record of those hours
and the basis for the seller's actual knowledge of what those hours
are--i.e., how the seller determined the hours.\41\ These related
provisions are intended to promote accuracy by sellers and facilitate
enforcement.
---------------------------------------------------------------------------
\40\ See discussion of section 315.5(b) infra.
\41\ See discussion of section 315.5(g) infra.
---------------------------------------------------------------------------
3. Sunday
The proposed definition of ``business hour'' excluded Sundays. The
Commission did not receive any comments advocating the inclusion of
Sundays in business hours. The evidence in the record also suggests
that most prescribers are closed that day.\42\ Accordingly, the
Commission retains the exclusion of Sundays from the definition of
business hour.
---------------------------------------------------------------------------
\42\ See, e.g., 1-800 CONTACTS (Comment 1140) at
attachment 32 (indicating 49% of retail optical chains, 91% of
independent optometrists, and 98% of ophthalmologists are closed on
Sunday).
---------------------------------------------------------------------------
4. Federal Holidays
The Commission's proposed definition of ``business hour'' did not
count Federal holidays. One commenter suggested that the definition
should include all Federal holidays except the ``major'' ones--i.e.,
Christmas, New Year's Day, and Thanksgiving--because ``most
businesses'' are open on the other Federal holidays.\43\ The record in
this
[[Page 40486]]
proceeding, however, does not provide evidence indicating that most
prescribers are open on the other Federal holidays. Because the Act is
intended to give prescribers eight business hours during which they are
open to respond to a verification request, the Commission declines to
count ``non-major'' Federal holidays in the definition of business hour
and, accordingly, retains the proposed definition of ``business hour''
as excluding Federal holidays.
---------------------------------------------------------------------------
\43\ Wal-Mart Optical Division (Comment 1070). See also
AC Lens (Comment 974) (arguing that Federal holidays should
only be the major ones when majority of retail businesses are
closed).
---------------------------------------------------------------------------
c. Calculation of Eight Business Hours
The Commission received a number of comments on its proposed method
of calculating eight business hours, some of which are discussed above.
Under the proposed Rule, the eight-hour verification period would have
expired--and a seller could ship a customer's order--at the start of
the next business hour after eight such hours had elapsed. Overall,
these comments objected to the ``eight-hours-plus-one-day''
verification period that would result in some circumstances.\44\ For
example, the State Attorneys General argued that the eight hours should
not exceed one business day; otherwise, it would undermine the Act's
intent to increase consumer choice and convenience.\45\ They pointed
out that the Act deems a prescription verified if the prescriber does
not respond ``within'' eight hours. The proposed Rule's requirement
that seller wait longer than those eight hours--and often an extra
day--before shipping is not justified and likely will have
anticompetitive effects.\46\
---------------------------------------------------------------------------
\44\ E.g., Hon. J. Sensenbrenner (Comment 1246)
(objecting to the eight-hours-plus-one-day calculation of eight
business hours).
\45\ State Attorneys General (Comments 1114,
1176).
\46\ See also The Independent Women's Forum (Comment
1236) (objecting to ``eight-hours-plus-one-day''
calculation); Hon. J. Sensenbrenner (Comment 1246) (same).
In addition, hundreds of consumers stated that an eight-hour-plus-
one-day verification period was too long. See, e.g., Comments
142, 143, 431, 463, 555, 571, 602-05, 616, 617, 620, 629,
631-36, 638, 640, 641, 644-47, 649, 670, 674, 680, 682, 685, 690,
691, 697, 709, 710, 726, 727, 731, 732, 746-51, 753, 754, 755, 760,
763, 766, 777, 779, 782, 787-89, 799, 803.
---------------------------------------------------------------------------
The Commission recognizes that its proposed method of calculation
would have imposed significant delays on sellers and consumers under
some limited circumstances. For example, a verification request
received after 5 p.m. on a Tuesday would not be deemed verified until 9
a.m. on Thursday. In addition, a request received after 5 p.m. on a
Friday would not be deemed verified until 9 a.m. the following
Tuesday--or at 9 a.m. the following Wednesday if Monday were a Federal
holiday. Although the latter scenario would not occur frequently, such
delay would have been significant.
Accordingly, the Commission has clarified in the final Rule that
the eight-hour verification period ends--and a seller may sell contact
lenses--when eight business hours have elapsed. Thus, for example, if a
prescriber receives a proper verification request before 9 a.m., the
seller may ship a customer's order at 5:01 p.m. if the prescriber has
not responded that the prescription is expired, inaccurate, or
otherwise invalid. Under this approach, prescribers will have a
reasonable opportunity to respond to verification requests, and
consumers will obtain the benefits from expeditious verification.
In addition, the Commission has clarified that the time period is
calculated from the time the prescriber receives a proper verification
request from a seller, rather than when the seller provides the request
to the prescriber as stated in the proposed Rule.\47\ That is, if a
prescriber receives a verification request during business hours (as
defined in the final Rule), the eight-hour verification period begins
immediately; if a prescriber receives a request during non-business
hours, the eight hours begins at the start of the next business hour.
This clarification is necessary to harmonize the definition of
``business hour'' with section 4(d)(3) of the Act, which provides that
a prescription is verified if the prescriber fails to communicate
``within eight (8) business hours after receiving from the seller'' the
information required to make a verification request.\48\
---------------------------------------------------------------------------
\47\ The proposed Rule had stated that eight business hours
would begin ``at the time that the seller provides the prescription
verification request to the prescriber.'' 69 FR at 5441.
\48\ 15 U.S.C. 7603(d).
---------------------------------------------------------------------------
d. Time Zone
A number of prescribers, as well as national and state optometric
associations, commented that the Rule should specify that business
hours are calculated based on the prescriber's time zone, not the
seller's.\49\ The Commission agrees that the Rule should make clear
which time zone applies. Given that Congress intended to give
prescribers eight business hours during which they are open to verify
prescriptions,\50\ the Commission concludes that ``business hour''
should be determined based on the prescriber's time zone, and has
revised the Rule accordingly.
---------------------------------------------------------------------------
\49\ E.g., M. Spittler (Comment 158); Wheaton Eye
Clinic (Comment 416); C.W. Kissling, O.D. (Comment
452); E. Attaya (Comment 952); Pennsylvania
Optometric Association (Comment 959); Olathe Family Vision
(Comment 971); Kansas Optometric Association (Comment
1153); Colorado Optometric Association (Comment
1067); New Mexico Optometric Association (Comment
1081); Kentucky Optometric Association (Comment
1101); National Association of Optometrists and Opticians
(Comment 1146); American Optometric Association (Comment
1149); Ohio Optometric Association (Comment 1151);
California Optometric Association (Comment 1158). Two other
commenters more generally asked the Commission to specify which time
zone applies. K. Poindexter (Comment 260); E. Lamp, O.D.
(Comment 714).
\50\ 15 U.S.C. 7603(d).
---------------------------------------------------------------------------
2. Definition of ``Commission'
The proposed Rule defined ``Commission'' to mean the Federal Trade
Commission.\51\ The Commission received no comments on this definition
and adopts it, without modification, in the final Rule.
---------------------------------------------------------------------------
\51\ See 69 FR at 5448.
---------------------------------------------------------------------------
3. Definition of ``Contact Lens''
The Act does not define the term ``contact lens.'' In the NPRM, the
Commission asked whether the Rule should define the term and, if so,
whether the definition should include non-corrective (e.g., decorative)
lenses.\52\
---------------------------------------------------------------------------
\52\ 69 FR at 5447.
---------------------------------------------------------------------------
The Commission received a number of comments on this issue. Most
commenters recommended defining the term, and most urged the Commission
to specifically include ``cosmetic,'' ``decorative,'' or ``non-
corrective'' lenses, or otherwise explicitly state that the Rule
applies to all contact lenses.\53\ The primary reason stated was that
both corrective and non-corrective lenses pose health risks to
consumers and therefore a prescription should be required to obtain
them. One commenter also stated that Congress did not draw any
distinction in the Act between different types of lenses, and therefore
the definition in the Rule should not.\54\
---------------------------------------------------------------------------
\53\ K. Green (Comment 4); C. Smith (Comment
6); M. Davis (Comment 8); M. Walker (Comment
10); W. Lindahl (Comment 16); W. West (Comment
126); Poindexter (Comment 260); Illinois
Optometric Association (Comment 1005); Kansas Board of
Examiners in Optometry (Comment 1007); American Optometric
Association (Comment 1149); Kansas Optometric Association
(Comment 1153); New Mexico Optometry Association (Comment
1081); Ohio Optometric Association (Comment
1151); California Optometric Association (Comment 1158).
\54\ American Optometric Association (Comment 1149).
---------------------------------------------------------------------------
Two commenters noted, however, that some cosmetic lenses currently
are available without a prescription.\55\ To
[[Page 40487]]
avoid ambiguity about the Rule's applicability to such lenses, one of
these commenters recommended that the Commission define ``contact
lens'' as ``any contact lens for which state or federal law requires a
prescription.'' \56\
---------------------------------------------------------------------------
\55\ American Society for Cataract and Refractive Surgery
(Comment 1148); Mercatus Center at George Mason University
(Regulatory Studies Program) (Comment 1087).
\56\ Mercatus Center at George Mason University (Regulatory
Studies Program) (Comment 1087).
---------------------------------------------------------------------------
The Act focuses on the release and verification of contact lens
prescriptions. The Act also prohibits advertising that contact lenses
``may be obtained without a prescription.'' \57\ The Commission thus
concludes that Congress intended the Act and implementing Rule to cover
only contact lenses for which a prescription is required. Accordingly,
the Commission has decided to add the following definition to the Rule:
``For purposes of the Rule, `contact lens' means any contact lens for
which state or federal law requires a prescription.''
---------------------------------------------------------------------------
\57\ 15 U.S.C. 7605.
---------------------------------------------------------------------------
4. Definition of ``Contact Lens Fitting''
Section 11(1) of the Act defines a ``contact lens fitting'' as
``the process that begins after an initial eye examination for contact
lenses and ends when a successful fit has been achieved or, in the case
of a renewal prescription, ends when the prescriber determines that no
change in the existing prescription is required.'' \58\ The Act states
that the fitting process ``may include--(a) an examination to determine
lens specifications; (b) except in the case of a renewal of a contact
lens prescription, an initial evaluation of the fit of the contact lens
on the eye; and (c) medically necessary follow-up examinations.'' \59\
The definition of ``contact lens fitting'' in the proposed Rule was
taken verbatim from the Act.\60\ For the reasons set forth below, the
Commission adopts this definition without modification in the final
Rule.
---------------------------------------------------------------------------
\58\ Id. at 7610(1).
\59\ Id.
\60\ See 69 FR at 5448.
---------------------------------------------------------------------------
A number of commenters suggested that the term ``medically
necessary follow-up examinations'' be defined specifically in the final
Rule.\61\ Based on the record, the Commission lacks the expertise to
define this term; moreover, it seems unlikely that even medical
professionals could list in advance all circumstances in which there
are valid medical reasons for a follow-up examination. Accordingly, the
Commission declines to define that term in the final Rule at this time.
The Commission, however, expects prescribers to exercise sound
professional judgment when determining if follow-up exams are
``medically necessary'' based on appropriate and objective standards of
medical care.
---------------------------------------------------------------------------
\61\ Consumers Union (Comment 1139) (recommending that
follow-up examinations must be medically indicated and occur within
30 days of the original fitting exam); R. Weigner (Comment
1118) (follow-up examination should be ``more strictly
defined so it cannot extend indefinitely''); American Society for
Cataract and Refractive Surgery (Comment 1148) (opposing a
Commission-determined standard, but recommending the Rule expressly
state ``as reasonably determined by the prescriber''); Illinois
Optometric Association (Comment 1005) (seeking a broader
definition such as ``medically necessary follow-up examinations and/
or sufficient follow up and lens parameter adjustment to minimize
the risks of contact lens complications as much as clinically
possible''); Dr. K. Poindexter (Comment 260).
One trade association also requested a clarification that the
initial evaluation includes giving a patient a pair of lenses to
wear on a trial basis, and that the fitting is not complete until
the prescriber settles on the final prescription. American Society
for Cataract and Refractive Surgery (Comment 1148). The
Commission believes that the proposed definition of ``contact lens
fitting'' clearly and sufficiently indicates that a contact lens
fitting may include an initial evaluation of the fit of the contact
lens on the eye (except in the case of renewals) as well as any
medically necessary follow-up exams.
---------------------------------------------------------------------------
5. Definition of ``Contact Lens Prescription''
Section 11(3) of the Act defines a ``contact lens prescription'' as
``a prescription, issued in accordance with State and Federal law, that
contains sufficient information for the complete and accurate filling
of a prescription for contact lenses, including the following: (a) The
name of the patient; (b) the date of examination; (c) the issue date
and expiration date of prescription; (d) the name, postal address,
telephone number, and facsimile telephone number of prescriber; (e) the
power, material or manufacturer or both of the prescribed contact lens;
(f) the base curve or appropriate designation of the prescribed contact
lens; (g) the diameter, when appropriate, of the prescribed contact
lens; and (h) in the case of a private label contact lens, the name of
the manufacturer, trade name of the private label brand, and, if
applicable, trade name of equivalent brand name.'' \62\ The definition
of ``contact lens prescription'' in the proposed Rule was taken
verbatim from Section 11(3) of the Act.\63\ For the reasons set forth
below, the Commission adopts the proposed definition without
modification in the final Rule.
---------------------------------------------------------------------------
\62\ 15 U.S.C. 7610(3).
\63\ See 69 FR at 5488.
---------------------------------------------------------------------------
a. Number of Lenses Prescribed
Several prescriber trade associations,\64\ one state optometry
board,\65\ and numerous individual prescribers \66\ recommended that
the Commission revise the definition to require the inclusion on the
prescription of the number of lenses or refills allowed. Many of these
commenters expressed concerned that the absence of such information
would allow patients to circumvent the prescription expiration date by
purchasing additional quantities of lenses before the prescription
expires.\67\ One of these commenters pointed out that the Act
contemplates that quantity limits are appropriate because it mandates
that sellers include the quantity ordered in their verification
requests.\68\
---------------------------------------------------------------------------
\64\ American Optometric Association (Comment 1149);
Illinois Optometric Association (Comment 1005); Kentucky
Optometric Association (Comment 1101).
\65\ Kansas Board of Examiners in Optometry (Comment
1007).
\66\ E.g., E. Attaya (Comment 952); G. Barker (Comment
125); S. Carlson, O.D. (Comment 906); M. R. Carter
(Comment 3); M. Dean (Comment 457); D. Deeds
(Comment 13); K. Green (Comment 4); W. Lindahl
(Comment 16); M. Palermo, O.D. (Comment 22); M.
Walker (Comment 165); Your Family Eye Doctors, Inc.
(Comment 705).
\67\ E.g., Kansas Board of Examiners in Optometry (Comment
1007); W. Lindahl (Comment 16).
\68\ American Optometric Association (Comment 1149).
---------------------------------------------------------------------------
Sellers, in contrast, noted that the Act does not provide for
prescribers to limit the number of boxes or units dispensed so long as
the prescription is current.\69\ The sellers further argued that such
restrictions could be used to impose expiration dates shorter than
those contemplated under the Act. Moreover, an academic ophthalmologist
commented that allowing prescribers to limit the number of refills
might encourage patients to overwear contact lenses in order to
``stretch'' their prescriptions to the end of the expiration
period.\70\ The same commenter noted that, if quantity limits are
imposed, patients who tear or lose their lenses or who have to replace
lenses more frequently may have prescriptions that run out before they
expire. In addition, one seller contended that patients may choose to
replace lenses more frequently than recommended by their prescriber,
and that such potentially healthier choices could be precluded if
prescriptions limit
[[Page 40488]]
the number of lenses that can be dispensed.\71\
---------------------------------------------------------------------------
\69\ AC Lens (Comment 974); William F. Shughart, II,
Ph.D., on behalf of 1-800-CONTACTS (Comment 975) .
\70\ P.S. D'Arienzo, M.D. (Comment 1056).
\71\ AC Lens (Comment 974).
---------------------------------------------------------------------------
After reviewing the comments, the Commission has decided not to
modify the definition of contact lens prescription to require the
inclusion of the quantity of lenses or refills allowed. The Act does
not require the inclusion of quantity information on the prescription.
In addition, if the quantity of lenses is included on the prescription,
then prescribers may use quantity limits to impose prescription
expiration dates that are effectively shorter than the one-year period
imposed under the Act. Moreover, it is not necessary to include the
quantity of lenses on the prescription to limit patients' ability to
circumvent the expiration date. Section 315.5(b) requires verification
requests to contain the quantity of lenses ordered, and as discussed
below in section 315.5(d), the quantity ordered may be a legitimate
basis for a prescriber to treat a request for verification of a
prescription as ``inaccurate.'' The verification process itself thus
generally allows prescribers to prevent patients from ordering
excessive contact lenses.
The Commission recognizes that some State laws or regulations may
require prescribers to include such information on the prescription.
Prescribers in States without such requirements may also choose to
include such information on the prescription.
The Commission, however, emphasizes that prescribers may not use
quantity limits to frustrate the prescription expiration requirements
imposed by section 315.6 of the final Rule. The quantity of lenses or
refills specified in the prescription must be sufficient to last
through the prescription's expiration date, which typically will be one
year after the issue date. If a lesser quantity of lenses or refills is
specified in the prescription, the prescriber must have a legitimate
medical reason for doing so, and the requirements imposed by section
315.6(b) of the final Rule on writing a prescription for less than one
year must be met.
b. Private Label Lenses
A few sellers commented on the Rule provision regarding private
label lenses.\72\ This provision requires prescriptions for private
label contact lenses to identify ``the name of the manufacturer, trade
name of the private label brand, and, if applicable, trade name of
equivalent brand name.'' \73\ Two sellers recommended that the Rule be
revised to require manufacturers of private label lenses to provide
information to prescribers regarding all equivalent brands, so that
this information can be included on the prescription.\74\ One of the
sellers stated that prescribers and sellers may not know which private
label lenses have equivalent brands, so there is currently no mechanism
by which sellers and prescribers can comply with subsection (8) of the
proposed definition.\75\ Nothing in the Act or its legislative history,
however, indicates that Congress intended to require contact lens
manufacturers to inform prescribers of brand names of equivalent
lenses. Consequently, the Commission has concluded that imposing such
disclosure requirements on manufacturers would exceed the mandate of
the Act.
---------------------------------------------------------------------------
\72\ Costco Wholesale Corporation (Comment 1061); AC
Lens (Comment 974); 1-800 CONTACTS (Comment 1140).
\73\ 69 FR at 5488.
\74\ Costco Wholesale Corporation (Comment 1061); AC
Lens (Comment 974).
\75\ Costco Wholesale Corporation (Comment 1061).
---------------------------------------------------------------------------
Another seller suggested that the definition be modified to require
those who prescribe private label contact lenses to identify on the
prescription the ``trade name of a brand name sold to alternative
sellers.'' \76\ Section 11(3)(H) of the Act requires that prescriptions
for private label contact lenses include the name of the manufacturer,
the private label brand name, and, if applicable, the ``trade name of
an equivalent brand name.'' \77\-\78\ Although the Act thus
expressly requires that ``equivalent brand name'' contact lenses be
identified in prescriptions for private label lenses, it does not
require that such ``equivalent brand name'' contact lenses be sold to
alternative sellers. The Commission has therefore concluded that
requiring prescribers to identify the ``trade name of a brand name sold
to alternative sellers'' would go beyond the requirements of the
Act.\79\
---------------------------------------------------------------------------
\76\ 1-800 CONTACTS (Comment 1140). This commenter was
also concerned about ``doctor exclusive lenses,'' which it described
as contact lenses sold by manufacturers only to eye care providers
and for which there are no available substitutes sold to alternative
sellers. The commenter suggested that the Rule require prescribers
who prescribe such ``doctor exclusive lenses'' to specify on the
prescription a brand name for lenses that are similar, but not
identical, to the prescribed lenses, and are sold to alternative
sellers. The Act requires disclosure only when lenses identical to
the prescribed lenses are sold under different private label brand
names. The imposition of a disclosure requirement for other lenses
is beyond the mandate of the Act.
\77\ \78\ 15 U.S.C. 7610(3)(H).
\79\ In addition, one prescriber trade association recommended
that subsection (8) of the definition be revised to state ``trade
name of identical brand name'' rather than ``trade name of
equivalent brand name'' to emphasize that prescription alteration is
not allowed. Illinois Optometric Association (Comment
1005). Because the phrase ``trade name of equivalent brand
name'' was taken directly from the Act, and there is no evidence in
the record indicating that the phrase is inappropriate, the
Commission has decided not to make the requested change.
---------------------------------------------------------------------------
c. Other Suggested Additions
A few prescribers recommended that a contact lens wearing schedule
be required on the prescription.\80\ A contact lens wearing schedule
outlines how often the contact lenses should be removed and/or
replaced. After reviewing these comments, the Commission has determined
that the record does not contain sufficient evidence to justify the
imposition of such a requirement in the final Rule. The Commission
notes, however, that the Rule does not prohibit a prescriber from
including such information on the prescription.
---------------------------------------------------------------------------
\80\ E.g., M. Walker (Comment 165); R. Carter (Comment
3).
---------------------------------------------------------------------------
One commenter suggested that the Commission modify the proposed
definition to require prescribers to include an e-mail address on
prescriptions for verification purposes, presumably to facilitate
communications between sellers and prescribers.\81\ Other commenters
recommended that an email address be allowed, but not required, on a
contact lens prescription because some prescribers may not use e-
mail.\82\ One such commenter pointed out that e-mail addresses are
likely to change frequently, particularly in rural areas.\83\ After
reviewing these comments, the Commission has decided not to revise the
Rule to require the inclusion of an e-mail address, because the record
contains no evidence regarding the extent to which prescribers use e-
mail to communicate. Although not required, a prescriber may choose to
include his or her e-mail address on a contact lens prescription, to
facilitate efficient communication between prescribers and patients as
well as between prescribers and sellers.
---------------------------------------------------------------------------
\81\ R.Weigner (Comment 1118).
\82\ American Society for Cataract and Refractive Surgery
(Comment 1148); K. Poindexter (Comment 260);
Illinois Optometric Association (Comment 1005).
\83\ Illinois Optometric Association (Comment 1005).
---------------------------------------------------------------------------
One prescribers' trade association recommended that the Rule
expressly allow contact lens prescriptions to include language
underscoring that there should be no substitutions.\84\ The
[[Page 40489]]
Act, however, permits substitution of identical contact lenses for
private label lenses.\85\ Consequently, the Commission has concluded
that this recommendation would be inconsistent with the Act.
---------------------------------------------------------------------------
\84\ American Optometric Association (Comment 1149). A
prescriber expressed a similar concern that contact lens sellers
``notoriously switch patients into what they see as equal or
identical contact lens [prescriptions]'' and added that ``this
practice should be stopped.'' S. Wexler, O.D. (Comment
375).
\85\ Section 4(e) of the Act, 15 U.S.C. 7603(f).
---------------------------------------------------------------------------
6. Definition of ``Direct Communication''
The proposed Rule defined ``direct communication'' to mean a
``completed communication by telephone, facsimile, or electronic
mail.'' \86\ In its NPRM, the Commission explained that, under this
definition, direct communication by telephone would require reaching
and speaking with the intended recipient, or leaving a voice message on
the telephone answering machine of the intended recipient; and direct
communication by facsimile or electronic mail would require that the
intended recipient actually receive the facsimile or electronic mail
message.\87\ For the reasons set forth below, the Commission adopts
this definition without modification in the final Rule.
---------------------------------------------------------------------------
\86\ 69 FR at 5448.
\87\ See id. at 5441.
---------------------------------------------------------------------------
a. Automated Telephone Systems
The Commission received a substantial number of comments objecting
to sellers' use of automated telephone systems to convey verification
requests to prescribers. Most of these commenters were individual
prescribers or prescriber trade associations, a number of whom argued
that automated requests do not constitute direct communication and
should be expressly prohibited under the Rule.\88\ Some commenters
bluntly stated that the automated systems currently in use simply
``don't work.'' \89\ Other commenters explained that so-called
``binary'' automated systems--which ask prescribers to press 1 to
verify or press 2 if not willing to verify--are inadequate. Binary
automated systems do not provide prescribers an option to correct any
inaccuracy; require an immediate response and thus do not allow the
prescriber eight business hours to verify; and do not provide the
option of speaking with the seller.\90\
---------------------------------------------------------------------------
\88\ E.g., American Optometric Association (Comment
1149); Nebraska Optometric Association (Comment
1083); Arizona Optometric Association (Comment
1072); Arizona Medical Association (Comment 1130);
Ohio Optometric Association (Comment 1151); Kansas
Optometric Association (Comment 1153); Kentucky Optometric
Association (Comment 1101); K. Driver, O.D. (Comment
273); Wheaton Eye Clinic (Comment 416); S. Bryant,
O.D. (Comment 1127); J. B. Rogers, O.D. (Comment
1119); B. Oppenheim (Comment 1).
\89\ E.g., Olathe Family Vision (Comment 971); Your
Family Eye Doctors, Inc. (Comment 705); Drs. Odom and
Coburn (Comment 958); see also A. Lee (Comment
1096) (``automatic calling by [a] robot is worthless''); R.
Garfield (Comment 19) (citing numerous problems with
automated phone verification); M. Przybylowski (Comment 9)
(same); S. Carpenter (Comment 182).
\90\ E.g., Texas Ophthalmological Association (Comment
1117); North Carolina State Optometric Society (Comment
1074); Oklahoma Association of Optometric Physicians
(Comment 1125); American Academy of Ophthalmology (Comment
1057); Illinois Optometric Association (Comment
1005).
---------------------------------------------------------------------------
Other commenters stated that automated systems often malfunction
\91\ or begin imparting information as soon as the prescriber's
telephone answering system picks up (e.g., for after-hours calls),
which frequently results in all or part of the message being cut off or
not recorded at all.\92\ Two prescribers objected that automated
verification systems are ``cumbersome'' and ``time-consuming'' for
staff who must respond to the verification request in real time while
patients are in their office waiting for service.\93\
---------------------------------------------------------------------------
\91\ E.g., Ohio Optometric Association (Comment 1151);
Oklahoma Association of Optometric Physicians (Comment
1125).
\92\ E.g., National Association of Optometrists and Opticians
(Comment 1146); Colorado Optometric Association (Comment
1067) (noting some recordings shut off automatically before
the message is complete); Kansas Optometric Association (Comment
1153) (noting that some optometrists' offices do not record
incoming messages at all).
\93\ J. Sawyer (Comment 814); D. Ball (Comment
849).
---------------------------------------------------------------------------
The Commission recognizes that automated telephone systems may
create communication problems as described in the comments received.
Nevertheless, we decline to revise the definition of ``direct
communication'' to prohibit the use of automated telephone verification
requests. The Act expressly authorizes sellers to send verification
requests by telephone,\94\ which is commonly understood to include
automated telephone systems. It would thus seem to be contrary to
Congressional intent to prohibit the use of this technology.
---------------------------------------------------------------------------
\94\ See 15 U.S.C. 7603(a)(2) (permitting prescription
verification by ``direct communication''), 7603(g) (defining
``direct communication'' to include communication by telephone).
---------------------------------------------------------------------------
Nevertheless, the Commission emphasizes that calls from automated
telephone systems must fully comply with all applicable Rule
requirements. For example, any automated verification request must (1)
provide complete verification request information as required under
section 315.5(b), and this information must be either received by a
person on the telephone or otherwise received in full (e.g., all of the
requisite information left on a telephone answering machine), and (2)
allow eight business hours for the prescriber to respond. If these and
other applicable requirements are not met, the automated verification
request is not valid.
In addition, the Commission will continue to monitor whether full,
valid requests for verification of a prescription are being made
through the use of automated telephone systems. If evidence
demonstrates that sellers are not making valid verification requests
but are providing consumers with contact lenses despite deficient
requests, the Commission may revisit this issue.
b. Technologies Used for ``Direct Communication''
Other commenters argued that the Commission should alter the scope
of technologies that may be used to achieve direct communication
between sellers and prescribers. Some commenters urged the Commission
to define ``direct communication'' more broadly than originally
proposed. For example, one seller suggested the term include the
existing technologies currently specified--facsimile, telephone, and e-
mail--plus any ``substantially equivalent communication technology,''
so as to specifically embrace future technologies.\95\ Other commenters
sought a narrower definition that would permit verification only
through a person-to-person telephone call; \96\ one commenter
recommended that the Rule permit only fax and e-mail communication, and
not telephone.\97\
---------------------------------------------------------------------------
\95\ 1-800 CONTACTS (Comment 1140). See also Mercatus
Center at George Mason University (Regulatory Studies Program)
(Comment 1087) (suggesting more open-ended definition--such
as adding ``or other electronic means''--rather than enumerating all
permissible communication options).
\96\ E.g., K. Poindexter (Comment 260) (arguing that
communication by fax and e-mail are not workable because seller has
no way to know when prescriber receives it and thus when the
communication was ``completed''); M. Walker (Comment 10)
(same); M. Davis (Comment 8) (same); Catherine Smith
(Comment 6) (same); K. Green (Comment 4) (citing
problems with fax--e.g., paper jam, no paper, no toner, memory
failure--and e-mail--e.g. blocked by anti-spam software or by ISP);
J. Maurillo (Comment 172) (suggesting that person-to-person
call be followed by a faxed confirmation); H. Cerri, M.D. (Comment
1129) (verification should occur by recorded telephone
call).
\97\ C.F. Ford, O.D. (Comment 969).
---------------------------------------------------------------------------
The Act plainly states that ``direct communication'' includes
communication by telephone, facsimile, or electronic mail.'' \98\
Accordingly, the
[[Page 40490]]
Commission cannot eliminate by rule any of the three specified methods.
As for expanding the definition to specifically reference ``future'' or
``substantially equivalent'' technology, Congress's use of the term
``includes'' contemplates that additional methods of communication may
develop that sellers and prescribers could use in the verification
process. There is no evidence in the record, however, of specific
additional technologies that sellers and prescribers currently use or
are likely to use in the verification process. Moreover, the Commission
cannot determine how the verification process would work, or how
recordkeeping requirements would apply, with respect to as-yet-unknown
technologies. If such other technologies develop, the Commission may
consider revising the Rule to permit those technologies to be used in
direct communication.
---------------------------------------------------------------------------
\98\ 15 U.S.C. 7603(g).
---------------------------------------------------------------------------
c. ``Completed'' Communication by Telephone, Facsimile or Electronic
Mail
Commenters also asked the Commission to define or clarify when a
``completed'' communication by telephone, facsimile or electronic mail
has occurred. One Internet-based contact lens seller proposed an
expansive definition that would include either (a) affirmative evidence
that a communication was completed, (b) evidence that a fax or e-mail
or substantially equivalent communication technology had been attempted
twice, or (c) evidence that live telephone verification had been
attempted.\99\ Another seller suggested that electronic confirmation of
a successful facsimile transmission, or the absence of notification
that an e-mail was undeliverable, should be sufficient evidence of
completed communication by those means.\100\
---------------------------------------------------------------------------
\99\ 1-800 CONTACTS (Comment 1140).
\100\ AC Lens (Comment 974) (Rule should not require
active acknowledgment of receipt by recipient, as that would be
contrary to the Act's passive verification scheme). See also
Mercatus Center at George Mason University (Regulatory Studies
Program) (Comment 1087) (urging Commission not to define
``completed'' communication too restrictively because the Act's
intent appears to tolerate some errors, such as e-mails lost in
cyberspace or a prescriber's fax machine running out of paper).
---------------------------------------------------------------------------
A number of prescribers sought narrower definitions of
``completed'' communications or more stringent requirements on sellers,
such as the receipt of a confirmation of successful fax transmission
and confirmation that someone was available in the prescriber's office
within the eight-hour time period to respond.\101\ Similarly, one
commenter sought a requirement that sellers call prescribers to verify
that the fax or e-mail verification request was in fact received, if
the prescriber does not respond within eight hours.\102\ One
optometrist argued that the Rule requires that the prescriber must
``receive'' the verification request, and the only way to ensure this
is to require some type of receipt or positive response from the
prescriber.\103\
---------------------------------------------------------------------------
\101\ Staff (Comment 131). See also C. Lesko, M.D. FACS
(Comment 960) (seller should have to verify that fax was
actually sent to and received by the appropriate prescriber's
office, so that consumers do not use fake prescriber names and fax
numbers).
\102\ American Society for Cataract and Refractive Surgery
(Comment 1148) (but proposing that fax confirmation and no
error e-mail notice (or notification that addressee has received
and/or read an e-mail) would be sufficient evidence of completion
for communications by prescriber to seller).
\103\ E. Lamp, O.D. (Comment 714).
---------------------------------------------------------------------------
The specific question of whether a message left on an answering
machine or voicemail constitutes a ``completed'' communication
generated a number of comments. Most of these comments--primarily from
prescribers and one of their trade associations--argued that the Rule
should not permit voice messages.\104\ These commenters stated, for
example, that they often had difficulty transcribing the messages, thus
increasing the potential for error,\105\ and that sellers should not be
allowed to leave confidential patient information on an answering
machine.\106\ Other commenters, however, favored allowing messages on
answering machines.\107\ One commenter argued that allowing voicemail
messages helps avoid extended ``phone tag,'' while another stated that
prohibiting such messages would impose a significant burden on smaller
sellers who are located in the Eastern time zone and are trying to
communicate with offices of prescribers in Western time zones.\108\
---------------------------------------------------------------------------
\104\ E.g., Kansas Board of Examiners in Optometry (Comment
1007) (arguing seller has no way to know when prescriber
receives message, and thus when eight-hour verification period
begins and ends); C.F. Ford, O.D. (Comment 969); A.L.
Warner (Comment 706); Wheaton Eye Clinic (Comment
416); E. Lamp, O.D. (Comment 714).
\105\ American Optometric Association (Comment 1149)
(suggesting at a minimum that prescribers be allowed to opt out of
telephone verification); E. Attaya (Comment 952)
(recordings are confusing and at times impossible to understand).
See also Drs. Odom and Coburn (Comment 958) (citing
difficulties with answering machine messages).
\106\ Staff (Comment 131).
\107\ E.g., R. Weigner (Comment 1118); Wal-Mart Optical
Division (Comment 1070) (arguing that it is reasonable to
presume that prescribers listen to their messages).
\108\ American Society of Cataract and Refractive Surgery
(Comment 1148); AC Lens (Comment 974) (noting that
message would include full information required by Act).
---------------------------------------------------------------------------
The language of the Act does not specifically define when a
seller's communication of verification information is completed.
Legislative history is instructive on the issue of what constitutes a
completed communication, however. In its Report, the House Committee
made clear that it intended direct communication to mean ``a message
[that] has been both sent and received.'' \109\
---------------------------------------------------------------------------
\109\ H. Rep. No. 108-318, at 10 (2003).
---------------------------------------------------------------------------
Having considered the comments, the Commission declines to further
define what constitutes a ``completed'' communication in the Rule.
However, the Commission confirms, as explained in the NPRM, that a
communication is ``completed'' when all of the required information is
received by the recipient. For example, direct communication by
telephone would require reaching and speaking with the intended
recipient, or clearly leaving a voice message on the telephone
answering machine of the intended recipient setting forth all of the
required information. Direct communication by facsimile or electronic
mail similarly would require that the intended recipient receive the
facsimile or electronic mail message. A facsimile confirmation will
usually provide a sufficient basis to conclude that a facsimile
communication was successfully received. E-mails are typically received
almost instantaneously after they are sent, so confirmation that an e-
mail was sent will generally constitute a sufficient basis to conclude
that the e-mail was received.\110\
---------------------------------------------------------------------------
\110\ However, if the sender has reason to believe that an e-
mail was not transmitted instantly (e.g., receiving an electronic
notification stating that the e-mail transmission was not
successful) or that a facsimile was not transmitted, then the
communication is not completed until it is actually received by the
recipient.
---------------------------------------------------------------------------
It is incumbent upon the party initiating the communication to use
a method that enables the recipient to receive all the information
being communicated, and the eight-business-hour verification period
does not begin until such receipt occurs. Moreover, sellers must
document the communications as provided in part 315.5(f) of the final
Rule.
The Commission also declines to impose additional requirements on
sellers to confirm receipt of communications by prescribers. The Act
reveals no indication that Congress intended to impose different
standards when sellers communicate with prescribers than when
prescribers communicate with sellers. The record
[[Page 40491]]
also does not provide sufficient evidence to warrant such a revision to
the Rule.\111\
---------------------------------------------------------------------------
\111\ The Commission also declines to allow the presumption of a
``completed'' communication based merely on evidence that a fax or
e-mail had been attempted twice, or evidence that live telephone
verification had been attempted, as one commenter suggested. The Act
requires that prescribers actually receive a verification request
for a direct communication to occur.
---------------------------------------------------------------------------
7. Definition of ``Issue Date''
Section 5(c) of the Act defines the ``issue date'' as ``the date on
which the patient receives a copy of the prescription.'' \112\ The
definition of ``issue date'' in the proposed Rule was taken verbatim
from the Act.\113\ Under section 315.6 of the Rule, contact lens
prescriptions may not expire less than one year after the ``issue
date'' unless medically necessary.
---------------------------------------------------------------------------
\112\ 15 U.S.C. 7604(c).
\113\ See 69 FR at 5448.
---------------------------------------------------------------------------
Several commenters suggested that the definition be modified to
make clear that the ``issue date'' is the date on which the prescriber
provides the patient with the prescription at the completion of the
examination or fitting.\114\ Most of these commenters indicated that a
prescriber giving an additional copy of a prescription to a patient at
some later date should not constitute another ``issue date.'' If it
did, the expiration date for the prescription could be extended one
year from the new issue date.\115\
---------------------------------------------------------------------------
\114\ American Optometric Association (Comment 1149);
Dr. K. Poindexter (Comment 260); W. West, O.D. (Comment
126); W. Barr, O.D. (Comment 1068); Arizona
Optometric Association (Comment 1072) (suggesting that
prescription expiration period begin when prescriber determines
contact lens parameters); 1-800 CONTACTS (Comment 1140)
(suggesting ``the date on which the patient, or any person
designated to act on behalf of the patient, first receives a copy of
the prescription'').
\115\ A few commenters suggested that the ``issue date'' be
defined as the date the prescriber writes the prescription or as
some earlier date. E.g., American Society for Cataract and
Refractive Surgery (Comment 1148) (suggesting the date the
prescriber writes the prescription); R. Weigner (Comment
1118) (suggesting the actual date on which the prescription
was written, and recommending that pre- or post-dating of
prescriptions be expressly disallowed); S.J. St. Marie, O.D.
(Comment 1121) (suggesting that the issue date be earlier
than the release date when the prescriber requires the patient to
use the lenses on a diagnostic trial basis). Section 5(c) of the Act
mandates the ``patient receipt'' standard contained in the proposed
Rule. Consequently, the Commission declines to implement the
requested changes in the final Rule.
---------------------------------------------------------------------------
Section 2(a)(1) of the Act requires a prescriber to provide a copy
of the prescription to the patient when the prescriber ``completes a
contact lens fitting.'' \116\ The Commission does not believe Congress
intended to allow patients to extend the prescription issue date--and
thereby extend the prescription expiration date--by obtaining
additional copies of prescriptions from prescribers subsequent to the
completion of the contact lens fitting. The Commission has therefore
concluded that the definition of ``issue date'' should be revised to
clarify that it is ``the date on which the patient receives a copy of
the prescription at the completion of a contact lens fitting.''
---------------------------------------------------------------------------
\116\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------
8. Definition of ``Ophthalmic Goods''
The proposed Rule defined ``ophthalmic goods'' to mean contact
lenses, eyeglasses, or any component of eyeglasses.\117\ The Commission
received no comments on this definition, and adopts it without
modification in the final Rule.
---------------------------------------------------------------------------
\117\ See 69 FR at 5449.
---------------------------------------------------------------------------
9. Definition of ``Ophthalmic Services''
The proposed Rule defined ``ophthalmic services'' to mean the
measuring, fitting, and adjusting of ophthalmic goods subsequent to an
eye examination.\118\ The Commission received no comments on this
definition, and adopts it without modification in the final Rule.
---------------------------------------------------------------------------
\118\ See 69 FR at 5449.
---------------------------------------------------------------------------
10. Definition of ``Prescriber''
The Commission's proposed Rule defined ``prescriber'' to mean, with
respect to contact lens prescriptions, an ophthalmologist, optometrist,
or other person permitted under State law to issue prescriptions for
contact lenses in compliance with any applicable requirements
established by the Food and Drug Administration.\119\ This definition
tracked the language of the Act verbatim.\120\
---------------------------------------------------------------------------
\119\ See 69 FR at 5449.
\120\ 15 U.S.C. 7610(2).
---------------------------------------------------------------------------
The Commission received a number of comments on this proposed
definition, most of which related to the application of this definition
to licensed opticians currently permitted under State law to fit
contact lenses. According to the commenters, these opticians--sometimes
referred to as ``dispensing opticians''--may perform a contact lens
fitting based on an eyeglass prescription that contains a notation from
the prescriber that the patient is ``OK for contact lenses'' or similar
language.\121\
---------------------------------------------------------------------------
\121\ E.g., K. Green (Comment 4); D. Acosta (Comment
14).
---------------------------------------------------------------------------
Several commenters, including the Opticians Association of America,
urged the Commission to make clear in the Rule that licensed dispensing
opticians must release contact lens prescriptions to their patients at
the end of a contact lens fitting.\122\ The California Association of
Dispensing Opticians noted that California law currently requires
dispensing opticians to release prescriptions to patients.\123\
---------------------------------------------------------------------------
\122\ K. Green (Comment 4); Opticians Association of
America (Comment 1059); California Association of
Dispensing Opticians (Comment 1104).
\123\ Comment 1104.
---------------------------------------------------------------------------
Having reviewed the comments, the Commission has concluded that, to
the extent dispensing opticians are authorized under state law to issue
prescriptions, they are ``prescribers'' under the Act and are required
to release contact lens prescriptions at the completion of a contact
lens fitting just like other prescribers. The Commission believes that
such a requirement is both consistent with, and necessary to fully
effectuate, Congress's intent to provide consumers with their
prescriptions. Accordingly, the Commission's final Rule defines
``prescriber'' to include opticians authorized or permitted under state
law to perform contact lens fitting services who also are permitted to
issue contact lens prescriptions.\124\
---------------------------------------------------------------------------
\124\ One commenter also recommended that the Commission revise
the definition of ``contact lens prescription'' to include ``an
eyeglass prescription and the notation `OK for contact lenses' or
similar language on the prescription provided there are no
contraindications for contact lenses.'' D. Acosta (Comment
14). The Commission believes the revised definition of
``prescriber'' adequately addresses this comment.
Another commenter recommended that the Rule prohibit anyone from
fitting and dispensing contact lenses unless that person is properly
licensed to write a prescription. Kentucky Optometric Association
(Comment 1101). See also Ohio Optometric Association
(Comment 1151) (urging Commission to state in the Rule that
contact lens ``fitting'' may be initiated and directed only by a
licensed optometrist or ophthalmologist). The question of who is
authorized to fit contact lenses is beyond the scope of the Act; it
is a question that is properly resolved as a matter of State law.
---------------------------------------------------------------------------
11. Definition of ``Private Label Contact Lenses''
Section 315.2 of the proposed Rule defines ``private label contact
lenses'' as ``contact lenses that are sold under the label of a seller
where the contact lenses are identical to lenses made by the same
manufacturer but sold under the labels of other sellers.'' \125\ This
proposed definition was derived from Section 4(f) of the Act.\126\ The
Commission received no comments on the proposed definition, and
therefore adopts it without modification in the final Rule.
---------------------------------------------------------------------------
\125\ 69 FR at 5448.
\126\ 15 U.S.C. 7603(f).
---------------------------------------------------------------------------
[[Page 40492]]
C. Section 315.3: Availability of Contact Lens Prescriptions to
Patients
1. 315.3(a)--In general
a. The Prescription Release Requirement
Section 2(a)(1) of the Act requires that ``when a prescriber
completes a contact lens fitting, the prescriber--(1) whether or not
requested by the patient, shall provide a copy of the contact lens
prescription to the patient.'' \127\ Section 315.3(a)(1) of the
proposed Rule tracks the language of the Act verbatim.\128\ For the
reasons set forth below, the Commission adopts this provision without
modification in the final Rule.
---------------------------------------------------------------------------
\127\ 15 U.S.C. 7601(a)(1).
\128\ See 69 FR at 5449.
---------------------------------------------------------------------------
As an initial matter, the Commission notes that thousands of
consumers submitted comments expressing strong support for the Act and
proposed Rule's prescription release requirement.\129\ Many of these
commenters felt strongly that the contact lens prescription belongs to
the consumer.\130\ Others stated that contact lens consumers should
have the same prescription release rights as eyeglasses wearers.\131\
---------------------------------------------------------------------------
\129\ E.g., Consumers (Comments 28, 29, 30,
31, 32, 33, 34, 36, 38, 40, 43, 44, 45, 48, 49, 51, 54, 56, 57, 59,
60, 64, 69, 71, 72, 73, 74, 75, 78, 79, 82, 83, 84, 87, 89, 90, 91,
92, 93, 94, 96, 97, 98, 100, 102, 105, 106, 107, 108, 109, 110, 111,
114, 115, 118, 119, 120, 121, 122, 123, 124, 132, 147, 152, 153,
155, 159, 163, 166, 169, 170, 171, 173, 174, 176, 178, 179, 181,
183, 184, 186, 187, 189, 190, 191, 192, 195, 198, 199, 201, 202,
203, 204, 205, 206, 207, 209, 210, 212, 213, 215, 217, 218, 219,
220, 222, 223, 226, 227, 228, 229, 230, 231, 232, 234, 235, 238,
240, 241, 242, 245, 246, 247, 248, 249, 250, 253, 255, 256, 257,
258, 259, 262, 263, 264, 265, 267, 272, 276, 281, 287, 289, 290,
292, 308, 315, 326, 327, 337, 342, 349, 358, 364, 380, 441, 451,
455, 465, 514, 519, 521, 539, 624, 653, 698, 726, 740, 761, 762,
765, 772, 775, 776, 777, 790, 793, 795, 798, 802, 806, 807, 808,
809, 813, 816, 820, 824, 825, 830, 836, 837, 841, 845, 848, 853,
859, 871, 873, 875, 878, 879, 880, 881, 892, 895, 897, 898, 922,
923, 936, 955, 967, 994, 1008, 1069, 1098, 1099, 1131, 1186, 1215,
1216, 1220, 1222, 1235).
\130\ E.g., Consumers [Comment 1201 (``I have
the undeniable right to have a copy of my Rx for my records, whether
I choose to do anything with it or not''); Comment