[Federal Register Volume 68, Number 155 (Tuesday, August 12, 2003)]
[Rules and Regulations]
[Pages 47847-47850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20491]


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DEPARTMENT OF JUSTICE

Bureau of Prisons

28 CFR Part 549

[BOP-1086-F]
RIN 1120-AA81


Over-The-Counter (OTC) Medications

AGENCY: Bureau of Prisons, Justice.

ACTION: Final rule.

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SUMMARY: In this document, the Bureau of Prisons (Bureau) establishes 
procedures governing inmate access to Over-The-Counter (OTC) 
medications. Currently, the inmate population can only buy approved OTC 
medications through the commissary at their institutions. Our 
commissaries will continue to sell medications such as aspirin, 
acetaminophen, ibuprofen, chlorpheniramine, antacids, hemorrhoidal 
ointment, hydrocortisone cream, and a fiber supplement (e.g. 
Metamucil[reg]), and other such medications used for symptomatic relief 
of common conditions. For inmates in inpatient status at our medical 
referral facilities, we will continue dispensing OTC medications at 
sick call. For all other inmates, we will continue dispensing OTC 
medications at sick call to inmates in the general population only if 
the inmate does not already have the OTC medication, and health 
services staff determine there is an immediate medical need which must 
be addressed before the inmate's regularly scheduled commissary visit, 
or that the inmate has no funds.
    We intend that these procedures will help us allocate medical 
resources efficiently and cost-effectively, while remaining consistent 
with the Bureau's scope of services which meet inmates' medically 
mandatory and medically necessary needs.

EFFECTIVE DATE: September 11, 2003.

ADDRESSES: Rules Unit, Office of General Counsel, Bureau of Prisons, 
320 First Street, NW., Washington, DC 20534.

FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General 
Counsel, Bureau of Prisons, phone (202) 307-2105.

SUPPLEMENTARY INFORMATION: We amend our regulations on Over-The-Counter 
(OTC) medications (28 CFR part 549, subpart B). We published a proposed 
rule on this subject in the Federal Register on March 1, 1999 (64 FR 
10094).

Summary of Public Comment

    We received six comments. One generally supported the proposed 
rule, but five commenters objected.
    Citing statutory authority requiring the Bureau to provide for the 
subsistence of persons charged to its custody, one commenter alleged 
that the proposed rule promoted the Bureau's economic interests over 
inmates' health needs and would further erode the quality of health 
care available to inmates.
    This commenter argued that conditions in Bureau facilities leave 
inmates vulnerable to infection. The commenter further stated that 
Bureau health services staff do not act responsibly. For example, the 
commenter states that, at one institution, sick call appointments may 
be scheduled 3 to 5 work days after the initial request. The commenter 
suggests that this is intended to discourage inmates from coming to 
sick call and that requiring inmates to buy OTC medications would deter 
inmates from making sick call appointments. The commenter further 
charges that the Bureau would use profits from the sale of OTC 
medications to fund tort claim or law suit settlements.
    Two additional commenters alleged that costs associated with the 
upkeep of inmates are the government's responsibility and should remain 
so. These commenters also objected to the pricing of OTC medications 
currently available in the institution's commissary. One commenter 
suggested that if the cost of OTC medications was passed on to the 
inmate, the inmate should be given a wider choice of medications. The 
other commenter alleged that staff were likely to abuse the 
administration of the proposed regulations and that staff improperly 
followed outdated procedures for addressing inmate complaints. The 
commenter also criticized the general quality of staff and the level of 
professional training available to staff.
    Another commenter stated that having OTC medications available 
through the commissary does not justify discontinuing sick call 
distribution. This commenter states that access to the commissary at 
some institutions is limited to one scheduled visit per week, that the 
commissary closes quarterly for inventory, and that the medications are 
not affordable or are overpriced. This commenter suggested that the 
proposed procedures may encourage inmates to break other Bureau rules, 
namely the prohibition on sharing personal property with other inmates.
    One commenter believes it is dangerous to permit mental health 
patients to purchase OTC medications which may adversely interact with 
prescribed medications. Another also objected to potential negative 
interactions between prescribed and OTC medications.
    Another commenter raised administrative procedural objections to 
the proposed rule and various Bureau policies for providing inmate 
health care. This commenter stated that the proposed rule did not cite 
a need for the change nor expected results from application of the new 
regulation. The commenter argued that OTC medications can be used for 
illnesses, and consequently the Bureau is contradicting itself when it 
states that OTC medications are being used for cosmetic and general 
hygiene issues.

[[Page 47848]]

    The commenter also disagreed with the Bureau's assertion that 
inmate health care conformed to community standards. The commenter 
criticized the actual provisioning of health care to inmates, citing as 
an example alleged misdiagnosis of a ``rash of illness over night among 
the prisoners'' at a Bureau institution.

Agency Response to Public Comment

    Administrative Procedure. Procedures for providing for the health 
needs of inmates in federal facilities are in the Bureau's Health 
Services Manual. Because these procedures conform to the community 
standard of medical care (requiring us to meet inmates' medically 
mandatory and medically necessary needs), the procedures do not require 
separate rulemaking.
    In instances where correctional management needs require 
adjustments to the procedures, we do go through rulemaking. For 
example, special provisions dealing with correctional management needs 
and chronic infectious disease are in 28 CFR part 549, subpart A.
    The provisions for OTC medications are another example where we go 
through rulemaking because of our correctional management needs. We 
believe these regulations are necessary to allocate medical resources 
efficiently and cost-effectively.
    The regulation should promote efficiency because Bureau health 
services staff will not need to see an inmate merely to dispense OTC 
medications. Health services staff can then devote more time to 
necessary medical care needs of inmates which they can only address 
through prescribed medications.
    Also, limiting free distribution of OTC medications reduces 
government expenses. While requiring the inmate to purchase OTC 
medications may increase costs to the inmate, doing so will prepare 
inmates for post-incarceration life where individuals have the 
opportunity and responsibility to address their health care needs 
through sensible and prudent use of OTC medications.
    Providing Health Care. By statute, we must provide for the 
safekeeping, care, and subsistence of the inmates in our custody. Title 
18 of the United States Code, section 4042(a)(2) states that, with 
regard to inmates, we must ``provide for their proper government, 
discipline, treatment, care, rehabilitation, and reformation.''
    We disagree with the comments that this rule will compromise our 
obligation to provide ``treatment'' and ``care'' to inmates or that 
inmates'' health is being used as the target of a money-making 
enterprise. This rule will, in fact, improve the quality of health care 
available to inmates: While continuing to meet inmates' medical needs 
by providing OTC medications in the commissary, we will free valuable 
medical staff time to more effectively meet inmates' medical needs.
    In fact, only OTC medications that are approved by the Pharmacy and 
Therapeutics Committee (the Bureau's national formulary board) are 
available for sale in institution commissaries. Under this regulation, 
our commissaries will continue to sell OTCs such as aspirin, 
acetaminophen, ibuprofen, chlorpheniramine, antacids, hemorrhoidal 
ointment, hydrocortisone cream, and a fiber supplement (e.g. 
Metamucil[reg]), and all other such medications that are available at 
the institution commissary.
    It is consistent with community standards to expect inmates to 
responsibly, sensibly and prudently use OTC medications. While inmates 
can get various OTC medications through the institution commissary, 
some may choose to get these same medications for free through sick 
call.
    The impact for the Bureau's medical resources is not limited merely 
to the cost of the free OTC medications dispensed at sick call, but 
also includes health services staff time, which could be more 
efficiently used during greater medical urgency. An inmate who needs to 
be evaluated by health care staff ought not to be deterred by the 
revised procedures. Instead of detracting from our quality of health 
care, this rule will allow us to use our health care resources where 
and when the inmates need them the most, thereby improving the quality 
of health care for inmates.
    To clarify that we will still dispense OTC medications to those who 
do not have ready access to commissary purchases, we state in the rule 
that it applies to all inmates except those in inpatient status at 
Federal Medical Centers. Those in inpatient status who, necessarily, do 
not have commissary access, will receive OTC medications as needed. All 
other inmates, who have commissary access and are physically able to 
purchase OTC medications at the commissary will be required to do so by 
this rule.
    Examples cited by some of the commenters of alleged excessive delay 
in scheduling sick call appointments may well be explained by the need 
for health services staff to spend time with inmates who attend sick 
call primarily to receive free OTC medications.
    Commissary Sales. National policy established by the FDA and the 
Department of Health and Human Services specifies what medical items, 
including OTC medications, our commissaries may sell, and a national 
Pharmacy and Therapeutics Committee (a Bureau formulary committee 
composed of a group of accredited pharmacists) annually reviews and 
modifies the list of permissible OTC medications. The committee reviews 
medications to ensure that, before we sell or give them to inmates as 
``OTC medications'', they are dispensed ``over the counter'' in the 
public community. In this way, we ensure that we conform to the 
community standard of medical care. The committee must give us 
permission before we may sell ``OTC medications'' to inmates in our 
commissaries.
    We operate the commissary under generally accepted accounting 
principles. We use profits from commissary sales to provide benefits to 
inmates in general. We do not use profits to fund tort claim or law 
suit settlements.
    Because of limitations imposed by the correctional setting, the 
institution commissary cannot offer the variety of items possibly 
available at local retailers. The commissary does not compete with 
local retailers, and we are not obligated to provide the lowest price 
on any particular item.
    In any case, as noted above, profits from commissary sales are used 
for the general benefit of inmates. Even so, we conducted surveys 
comparing the prices of identical or similar items sold in retail 
convenience stores and supermarkets in the community surrounding the 
correctional institutions to assist in pricing policies.
    One survey of 50 commissary items was conducted at the following 
locations: LSCI Allenwood, FPC Alderson, USP Leavenworth, FCI Dublin, 
FMC Fort Worth, and FCI Miami. We compared the prices of commissary 
items to identical or similar items in a local retail convenience store 
and a local supermarket at each location. In 70 percent of the 
comparisons, we found that the items surveyed were less expensive in 
the commissaries than in the local convenience stores and supermarkets.
    While we limit access to the institution commissary, the proposed 
regulations allow for exceptions where health services staff determine 
that the inmate has an immediate medical need which must be addressed 
before the inmate's regularly scheduled commissary visit (see Sec.  
549.30(a)). The proposed regulations also allow for exceptions where 
the inmate does not have access to the commissary because

[[Page 47849]]

the inmate is in administrative detention or special housing.
    Inmates Without Funds. The proposed regulations also allow for 
exceptions to be made for inmates without funds. In the final rule, we 
define an inmate without funds as one who has had an average daily 
trust fund account balance of less than $6.00 for the past 30 days. 
This definition is similar to that used in the Bureau's inmate 
telephone regulations (see Sec.  540.105(b)) and in implementing 
instructions for payment of postage procedures (Sec.  540.21(d) and 
(e)). We believe this definition has proved to be both warranted and 
reasonable.
    Interactions. Federal law and Bureau policy addresses issues on 
drug interactions between prescribed and OTC medications. These laws 
and our policy require verbal and/or written counseling information for 
all prescription drugs. When we prescribe such drugs, we give inmates 
information about potential drug-drug and drug-food interactions, 
including those with OTC medications.
    Also, the regulations specify that Bureau medical centers (that is, 
the U.S. Medical Center for Federal Prisoners, other Federal Medical 
Centers, and psychiatric referral centers) will continue dispensing OTC 
medications through sick call, where inmates taking complex medication 
regimens, or inmates with cognitive impairments, would be at higher 
risk of inadvertent drug interactions with OTC medications.
    Commissary procedures on the amount of items sold through the 
commissary serve to minimize the potential for misuse of purchased OTC 
medications.
    Miscellaneous Issues. We believe that our discipline policy (see 28 
CFR part 541, subpart B) will discourage inmates from violating Bureau 
regulations.
    Concerns expressed over possible abuse of the administration of the 
proposed regulations, training available to staff, or over the general 
quality of staff are not relevant to the procedures of this specific 
proposed rule. Our administrative remedy program (see 28 CFR part 542) 
permits inmates to seek formal review of issues which relate to their 
confinement and is the appropriate channel to seek redress.
    One commenter alleged that the administrative remedy program itself 
is outdated and improperly followed by staff. We disagree. 
Nevertheless, we will be revising the regulations for the 
administrative remedy program as part of the ``plain language'' 
initiative.
    Members of the public may submit further comments concerning this 
rule by writing to the previously cited address. We will consider but 
not respond to these comments in the Federal Register.

Executive Order 12866

    This regulation has been drafted and reviewed in accordance with 
Executive Order 12866, ``Regulatory Planning and Review'', section 
1(b), Principles of Regulation. The Director of the Bureau of Prisons 
has determined that this rule is not a ``significant regulatory 
action'' under Executive Order 12866, section 3(f), and accordingly 
this rule has not been reviewed by the Office of Management and Budget.

Executive Order 13132

    This regulation will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on distribution of power and responsibilities among the 
various levels of government. Under Executive Order 13132, this rule 
does not have sufficient federalism implications for which we would 
prepare a Federalism Assessment.

Regulatory Flexibility Act

    The Director of the Bureau of Prisons, under the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), reviewed this regulation. By 
approving it, the Director certifies that it will not have a 
significant economic impact upon a substantial number of small entities 
because: This rule is about the correctional management of offenders 
committed to the custody of the Attorney General or the Director of the 
Bureau of Prisons, and its economic impact is limited to the Bureau's 
appropriated funds.

Unfunded Mandates Reform Act of 1995

    This rule will not cause State, local and tribal governments, or 
the private sector, to spend $100,000,000 or more in any one year, and 
it will not significantly or uniquely affect small governments. We do 
not need to take action under the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This rule will 
not result in an annual effect on the economy of $100,000,000 or more; 
a major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.

Plain Language Instructions

    We want to make Bureau documents easier to read and understand. If 
you can suggest how to improve the clarity of these regulations, call 
or write to Sarah Qureshi at the address or telephone number listed 
above.

List of Subjects in 28 CFR Part 549

    Prisoners.

Harley G. Lappin,
Director, Bureau of Prisons.

0
Under the rulemaking authority vested in the Attorney General in 5 
U.S.C. 552(a) and delegated to the Director, Bureau of Prisons, we 
amend 28 CFR part 549 as follows.

Subchapter C--Institutional Management

PART 549--MEDICAL SERVICES

0
1. Revise the authority citation for 28 CFR part 549 to read as 
follows:

    Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 3622, 3624, 4001, 4005, 
4042, 4045, 4081, 4082 (Repealed in part as to offenses committed on 
or after November 1, 1987), 4241-4247, 5006-5024 (Repealed October 
12, 1984, as to offenses committed after that date), 5039; 28 U.S.C. 
509, 510.


0
2. Add a new Subpart B, consisting of Sec. Sec.  549.30 and 549.31, to 
read as follows:
Subpart B--Over-The-Counter (OTC) Medications
Sec.
549.30 Purpose and scope.
549.31 Inmates without funds.

Subpart B--Over-The-Counter (OTC) Medications


Sec.  549.30  Purpose and scope.

    This subpart establishes procedures governing inmate access to 
Over-The-Counter (OTC) medications for all inmates except those in 
inpatient status at Federal Medical Centers. Inmates may buy OTC 
medications which are available at the commissary. Inmates may also 
obtain OTC medications at sick call if the inmate does not already have 
the OTC medication and:
    (a) Health services staff determine that the inmate has an 
immediate medical need which must be addressed before his or her 
regularly scheduled commissary visit; or
    (b) The inmate is without funds.


Sec.  549.31  Inmates without funds.

    (a) The Warden must establish procedures to provide up to two OTC 
medications per week for an inmate without funds. An inmate without 
funds

[[Page 47850]]

is an inmate who has had an average daily trust fund account balance of 
less than $6.00 for the past 30 days.
    (b) An inmate without funds may obtain additional OTC medications 
at sick call if health services staff determine that he/she has an 
immediate medical need which must addressed before the inmate may again 
apply for OTC medications under this section.
    (c) To prevent abuses of this section (e.g., inmate shows a pattern 
of depleting his or her commissary funds before requesting OTC 
medications), the Warden may impose restrictions on the provisions of 
this section.
[FR Doc. 03-20491 Filed 8-11-03; 8:45 am]
BILLING CODE 4410-05-P