July 15, 2016 Julie Dohm, J.D., Ph.D. Senior Science Advisor Food

July 15, 2016
Julie Dohm, J.D., Ph.D.
Senior Science Advisor
Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 6117
Silver Spring, Maryland 20993
Re:
Long-Term Care Pharmacy
Dear Dr. Dohm:
The Senior Care Pharmacy Coalition (“SCPC”), the American Health Care Association
and the National Center for Assisted Living (“AHCA/NCAL”), and the American Society of
Consultant Pharmacists (“ASCP”) appreciated the opportunity to participate in the
pharmacy-focused listening session that you hosted on June 6, 2016. This letter provides a
general comment about long-term care (“LTC”) pharmacy, and addresses three specific groups
of questions related to LTC emergency kits (“e-kits”) that you and other representatives of the
Food and Drug Administration (“FDA”) posed during the meeting.
The SCPC, AHCA/NCAL, and ASCP (collectively, the “Associations”) believe it is
extremely important that FDA is taking steps to understand the operational requirements, facility
relationships, and practical considerations affecting LTC residents.1 FDA must recognize the
demands of other regulators that control LTC care for our nation’s vulnerable seniors, and avoid
imposing inappropriate new burdens on complex and already well-controlled systems. FDA also
must recognize that the practice patterns of LTC pharmacies are truly those of professional
pharmacy, not commercial product repackagers or distributors.
1
Similar to information that the SCPC submitted in prior comments, a recent white paper found: “While the resident
profile and length of stay vary for every facility, most long-term care residents have multiple comorbidities and are
on numerous medications. The ‘typical’ skilled nursing facility (SNF) resident is female and over the age of 85.”
On average, residents receive 12 prescription medications per month. McKesson, Becoming a Long-Term Care
Pharmacy: Opportunities and Important Considerations (2015 [“Becoming an LTC Pharmacy”]) at 1, 3; available at
http://becomeahealthmart.com/Websites/becomeapharmacy/images/Whitepaper-Becoming_a_LongTerm_Care_Pharmacy.pdf.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 2
The Centers for Disease Control and Prevention (“CDC”) has projected that the number
of people requiring long-term care will grow substantially between now and 2050:2
Most of this increase will be due to growth in the older adult population who need
such services. Although people of all ages may need long-term care services, the
risk of needing these services increases with age. Recent projections estimate that
over two-thirds of individuals who reach age 65 will need long-term care services
during their lifetime. Largely due to aging baby boomers, the population is
expected to become much older, with the number of Americans over 65 projected
to more than double, from 40.2 million in 2010 to 88.5 million in 2050. The
estimated increase in the number of the “oldest old” – those aged 85 years and
over – is even more striking. The oldest old are projected to almost triple, from
6.3 million in 2015 to 17.9 million in 2050, accounting for 4.5% of the total
population.
LTC pharmacies – sometimes called “closed-door” or “institutional” pharmacies – are a
distinct subset within the pharmacy community. Skilled nursing facilities (“SNFs”), nursing
facilities (“NFs”), 3 and many assisted living facilities (“ALFs”) contract with a single LTC
pharmacy to prepare and dispense prescription drugs for individual patients, and to provide an
array of consulting pharmacy and care planning services required by Medicare, Medicaid, state
licensure laws, and professional standards.
The Associations
The SCPC is the national association for independent LTC pharmacies.4 Our member
pharmacies provide care and services to patients in LTC facilities in more than 40 states
occupying approximately 400,000 beds across the country. The SCPC advocates for public
policies that protect patients, improve the quality of healthcare across a shifting care continuum,
and strengthen the economic viability of independent LTC pharmacies and their ability to serve
medically compromised seniors.
2
U.S. Centers for Disease Control and Prevention, Long-Term Care Providers and Services Users in the United
States: Data From the National Study of Long-Term Care Providers, 2013–2014 (Feb. 2016) at 3, available at
http://www.cdc.gov/nchs/data/series/sr_03/sr03_038.pdf.
3
Both the statute and the regulations use “skilled nursing facilities” to refer to facilities qualified to provide care and
services to Medicare beneficiaries and use the term “nursing facilities” to refer to facilities qualified to provide care
and services to Medicaid beneficiaries. For purposes of this letter, the terms “nursing home” or “nursing facility”
refer to skilled nursing facilities and nursing facilities, as well as facilities regulated under state law as nursing
homes.
4
Alongside a few major corporations, more than 1,100 independent LTC pharmacies serve the market in the U.S.
Based on 2014-2015 data, the average independent LTC pharmacy is a single pharmacy serving 10 to 13 LTC
facilities, with 80 to 100 residents per facility. Becoming an LTC Pharmacy at 3.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 3
AHCA/NCAL represents over 13,000 skilled nursing facilities, or 1.063 million beds,
and more than 209,000 assisted living facility beds. With such a membership base,
AHCA/NCAL represents the vast majority of SNFs and a rapidly growing number of ALFs.
ASCP is the nation’s leading professional association representing America’s consultant
pharmacists, whose mission is to provide comprehensive pharmaceutical care for the frail
elderly.
The Associations stand ready to provide further information to FDA with respect to LTC
pharmacy topics.
I.
EXECUTIVE SUMMARY
LTC pharmacies dispense patient-specific prescriptions to residents of contracted nursing
facilities and many ALFs. FDA should expressly exempt these activities from the scope of its
repackaging guidance. LTC pharmacy dispensing includes (although is not limited to) three
common practices that are within the traditional practice of pharmacy and should clearly be
exempt:
II.

Packaging drugs into special packaging (e.g., unit-dose packaging) required by LTC
facilities for patient-specific prescriptions (whether such packaging occurs in
anticipation of or after the receipt of the patient-specific prescriptions).

Filling stock into a canister, blister card, or unit-dose container that will be placed in
remote dispensing equipment at an LTC facility.

Preparation and placement of emergency medications in e-kits required for LTC
facilities.
GENERAL STATUS: ALL LTC DRUGS SHOULD BE EXEMPT FROM FDA’S
“REPACKAGING” GUIDANCE
The Associations continue to request that FDA exempt all drugs dispensed through LTC
pharmacies – including, but not limited to, those in e-kits – from the agency’s “repackaging”
guidance. As discussed in our prior comments to the agency:

LTC pharmacies are engaged in patient-specific dispensing, in accordance with state
pharmacy laws.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 4

This is true whether:
o an LTC pharmacy places its drugs for dispensing in required “special
packaging” in anticipation of or after receiving prescriptions for the product.
(Put another way: all products leaving the pharmacy are identically packaged,
labeled, documented, and shipped to an LTC resident, in full conformance
with pharmacy and other law);
o an LTC pharmacy fills stock into a canister, blister card, or unit-dose
container that will be placed in remote dispensing equipment at an LTC
facility. These automated dispensing systems are owned by the LTC
pharmacy and both the systems and any medications in them remain under the
care, custody, and control of the pharmacy. Moreover, the systems are
monitored and controlled remotely by the pharmacist, and the pharmacist will
not authorize dispensing of any medications from such systems without a
patient-specific prescription or chart order; and
o an LTC pharmacy prepares and places a small number of unit-dose quantities
of emergency medications into an e-kit for possible urgent dispensing to an
LTC resident following physician order.
LTC pharmacy dispenses in such a manner for a very specific reason – to comply with
the Centers for Medicare and Medicaid Services’ (“CMS”) requirements for Network Long Term
Care Pharmacies (“NLTCP”), found in the CMS Part D Manual, Chapter 5, Section 50.5 (“Part
D Manual”). 5 The Part D Manual expressly requires NLTCPs to dispense drugs in “special
packaging.” Yet, most drugs cannot be purchased already prepackaged in such special
packaging.
Among other provisions, the Part D Manual requires:
(1) Special Packaging – NLTCPs must have the capacity to provide specific drugs
in unit of use packaging, bingo cards, cassettes, unit dose or other special
packaging commonly required by LTC facilities. NLTCPs must have access
to, or arrangements with, a vendor to furnish supplies and equipment
including but not limited to labels, auxiliary labels, and packing machines for
furnishing drugs in such special packaging required by the LTC setting.
(2) Delivery Service – NLTCPs must provide for delivery of medications to the
LTC facility up to 7 days each week (up to 3 times per day) and in-between
regularly scheduled visits. Emergency delivery service must be available 24
5
See https://www.cms.gov/medicare/prescription-drugcoverage/prescriptiondrugcovcontra/downloads/memopdbmanualchapter5_093011.pdf.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 5
hours a day, 7 days a week. Specific delivery arrangements will be
determined through an agreement between the NLTCP and the LTC facility.
NLTCPs must provide safe and secure exchange systems for delivery of
medication to the LTC facility. In addition, NLTCPs must provide
medication cassettes, or other standard delivery systems, that may be
exchanged on a routine basis for automatic restocking. The NLTCP delivery
of medication to carts is a part of routine “dispensing.”
(3) Emergency Boxes – NLTCPs must provide “emergency” supply of
medications as required by the facility in compliance with State requirements.
(4) Emergency Log Books – NLTCPs must provide a system for logging and
charging medication used from emergency/first dose stock. Further, the
pharmacy must maintain a comprehensive record of a resident’s medication
order and drug administration.
Applicable guidance further explains that “to qualify as an LTC pharmacy for a Part D
sponsor’s LTC pharmacy network, a pharmacy must currently have the capacity – either by itself
or through subcontracts with other entities – to meet all these performance and service criteria,
even if an LTC facility that pharmacy serves does not need a particular service subsumed under
those performance and service criteria.” Thus, this special packaging is a mandate of federal
law.
As FDA already knows, it is the routine practice of LTC pharmacies to purchase many
medications in bulk, and to place them into specialized packaging for dispensing to LTC
residents.6 Unfortunately, the vast majority of drugs dispensed to nursing home residents by
LTC pharmacies are not available for purchase from a manufacturer, supplier, or repackager, in
the type of unit dose specialized packaging required by the CMS regulations and sub-regulatory
guidance. While some limited number of products are available for purchase, the vast majority
of products dispensed by LTC pharmacies are not available from manufacturers, suppliers or
repackagers in appropriately compliant packaging.7 It is for this reason that LTC pharmacies
today undertake their own efforts to package medications being dispensed to nursing home
residents in the needed packaging – because the products are simply not available otherwise. If
the draft Guidance is finalized as proposed, however, the only alternative available to LTC
6
For example, in 2013, CMS issued a regulation and guidance pursuant to Section 3310 of the Affordable Care Act
of 2010 that requires certain drugs for Medicare Part D beneficiaries residing in skilled nursing facilities to be
dispensed in quantities of 14 days or less. In response to this requirement many LTC pharmacies invested in
dispensing technology (Talyst, AP Passport, Strip Packaging, etc.) that would reduce waste. CMS’ regulation
effectively requires LTC pharmacy to utilize dispensing technology that requires “repackaging.” This is but another
example of the regulatory conflict that the proposed Guidance will create if finalized without exempting LTC
pharmacy from its scope.
7
SCPC members estimate that products available from manufacturers, suppliers, or repackagers in compliant
packaging is 10% or less.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 6
pharmacies would be to register themselves as repackagers. We suggest that having thousands
of community-based LTC pharmacists taking on this significant regulatory burden cannot have
been Congress’ intent under the DQSA, and we suggest that FDA is likely not interested in
regulating the nearly 1,400 entities engaged in providing LTC pharmacy services.
In sum, the FDA Guidance, if finalized as proposed regarding LTC pharmacy, would
require all LTC pharmacies to either leave the LTC business or register as repackagers –
something that the typical LTC pharmacy consisting of a single facility with under $5 million in
revenue can ill afford to do. While we appreciate that the cost of compliance is not FDA’s
concern, there is no evidence that LTC pharmacy repackaging has ever created a health or safety
issue for LTC residents. Thus, we respectfully suggest that in light of the CMS and State
regulatory requirements, FDA should continue to exercise its enforcement discretion over LTC
pharmacy repackaging, and exclude LTC pharmacy from the draft Guidance’s repackaging
requirements.
III.
QUESTIONS FROM FDA LISTENING SESSION
The foregoing discussion concerns a number of core dispensing activities that would be
adversely impacted -- and that warrant exemption in any event -- from FDA’s repackaging
guidance. FDA posed the following questions during the June 6 listening session.
1. Are LTC emergency kits (“e-kits”) distinguishable from physician office stock? If
pharmacy distribution of prescription drug products for office stock use may be
limited, why should e-kit medications that LTC pharmacies supply to nursing
homes be treated differently?
RESPONSE:
As noted above, federal Medicare and Medicaid Requirements of Participation mandate
that LTC nursing facilities in the U.S. make emergency (as well as routine) medications available
to patients.8 In other words, there is a legal responsibility for patient care. The Associations are
not aware of a similar, affirmative requirement applicable to physician office stock.
8
42 C.F.R. § 483.60 (LTC facility must provide routine and emergency drugs and biologicals to its residents, or
obtain them under an agreement described in § 483.74(h)). See also the Part D Manual quoted above. The crossreferenced 42 C.F.R. § 483.74 requires a Part D participating facility to be “administered in a manner than enables it
to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and
psychosocial well-being of each resident.” Subparagraph (h) expressly authorizes the use of outside resources: “If
the facility does not employ a qualified professional person to furnish a specific service to be provided by the
facility, the facility must have that service furnished to residents by a person or agency outside the facility…”
(emphasis added).
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 7
Furthermore, e-kits involve LTC pharmacy “dispensing” to patients, whereas office stock
involves drug “distribution” from one entity to another. The vast majority of LTC facilities do
not employ staff physicians9 or maintain in-house pharmacies. Instead, these facilities rely upon
contracted LTC pharmacies to dispense routine and emergency medications following
prescription by a patient’s physician.
E-kits are an officially recognized tool by which very small quantities of pharmaceutical
products can be staged by a LTC pharmacy – still under the pharmacy’s control – in advance of
(but in anticipation of) being dispensed pursuant to patient-specific prescriptions or chart orders.
E-kits have been required by CMS since at least 1987. They have been acknowledged and
allowed by the federal Drug Enforcement Administration (“DEA”) for more than 35 years: 10
To facilitate the dispensing of controlled substances in emergencies, DEA has
allowed pharmacies to place in LTCFs [long-term care facilities] “emergency
kits” that are routinely stocked with commonly dispensed controlled substances
(45 FR 24128, April 9, 1980). These kits are considered extensions of the
pharmacy and are controlled under the pharmacy’s DEA registration. Again, the
same requirement of a valid prescription delivered to the pharmacy prior to
dispensing applies with respect to these kits; however, they provide an immediate
supply of drugs in emergencies and eliminate the need to wait for a delivery from
the pharmacy in such circumstances.
E-kits also are also recognized under state laws. For example, Nebraska law specifies
that:
Drugs may be administered to residents of a long-term care facility by authorized
personnel of the long-term care facility from the contents of emergency boxes
located within such long-term care facility if such drugs meet all of the following
requirements: (1) All emergency boxes shall be provided by and all emergency
boxes containing such drugs shall be sealed by a supplying pharmacy with the
seal on such emergency boxes to be of such a nature that it can be easily identified
if it has been broken….11
Examples from other states are available.12
9
See further discussion of this issue in Section III.2, below.
10
DEA, Dispensing of Controlled Substances to Residents at Long Term Care Facilities, Notice; Solicitation of
information, 75 Fed. Reg. 37463, 37465 (June 29, 2010).
11
12
Neb. Rev. Stat. § 71-2412 (emphasis added).
See, e.g., Arkansas State Board of Pharmacy Regulation 05-00-0005 (all contents of the emergency kit will be
provided by one pharmacy designated by the long term-care facility).
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 8
The Associations are not aware of a comparable regime or set of laws or regulations that
require physicians to maintain office stocks of drug products.
There is, furthermore, a legal distinction between e-kit drug products, which are
ultimately controlled by the pharmacist and “dispensed” from an e-kit only following a patientspecific prescription or chart order by a practitioner, versus “distribution” of drug products from
a manufacturer, wholesaler, or other supplier to a physician for non-patient-specific office stock
and subsequent dispensing or administration. A pharmacy providing drug product for use in an
e-kit is the “practice of pharmacy.”13 FDA has long recognized that the “practice of pharmacy”
is exempt from certain FDA oversight and regulation. For example, 21 C.F.R. § 207.10 provides
an exception to the registration requirement for “pharmacies that operate under applicable local
laws regulating dispensing of prescription drugs and that do not manufacture or process drugs for
sale other than in the regular course of the practice of the profession of pharmacy.…”
Furthermore, FDA Compliance Manual 7356.002B on Field Alert Reporting Requirements for
Drug Repackagers and Relabelers states that “[p]re-packagers operating within the practice of
pharmacy and distributing (selling) drugs upon receipt of written prescriptions” are excluded
from the repackaging/repackager requirements. Lastly, in FDA’s May 1999 Guidance document
titled “Container Closure Systems for Packaging Human Drug and Biologics” when discussing
repackagers, FDA expressly noted that the “discussion does not apply to the repackaging of
drugs products for dispensing under the practice of pharmacy.”
Even if FDA may not find this legal distinction fully clear, the Associations are aware
that FDA has recognized in other institutional/health care facility settings that the practice of
pharmacy may take place across physically separate, but closely allied, operations – and that
certain preparatory activities may occur even before a prescription has been issued. 14 We
respectfully request similar consideration in this institutional health care setting. (LTC
pharmacies should not be treated as outpatient pharmacies.)
The Associations believe it is evident that the preparation, dispatch, and ongoing
management of e-kits falls within “dispensing” and the traditional practice of pharmacy. In any
case, it is appropriate for FDA to interpret the practice of pharmacy to cover the staging of e-kit
drugs by LTC pharmacies at LTC facilities as the type of physically separate, but directly allied,
operations that coordinate directly to serve LTC residents’ urgent needs. The same cannot be
said for the sale of drug product to a prescriber for office use.
13
The Associations intend in this letter to clarify how e-kits (which are managed primarily by the issuing pharmacy
through the time of dispensing) are different than office stock.
14
Just this year, for example, FDA proposed criteria to recognize scenarios in which centralized institutional
pharmacies may compound and dispatch products for nearby institutional locations, even in advance of any patientspecific prescription being issued. See Draft Guidance for Industry: Hospital and Health System Compounding
Under the Federal Food, Drug, and Cosmetic Act (April 2016).
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 9
2. Why does the LTC pharmacy need to manage e-kits? Can an LTC nursing facility
purchase and hold commercially-supplied drug products for emergency use directly
from a manufacturer or wholesaler?
RESPONSE:
As noted above, licensed pharmacists and licensed physicians are generally authorized by
applicable training and state professional laws to dispense prescription drug products to
patients.15 However, LTC nursing facilities generally do not employ full-time physicians or full
time pharmacists. Federal Medicare and Medicaid requirements specify that physicians must see
each nursing home resident only once every thirty days absent specific patient need. They also
specify that LTC nursing facilities must have a consulting pharmacist, but he or she need not be,
and is not, on-site on a full-time basis. Although federal law also requires that each LTC nursing
facility employ a Medical Director, he or she is not at the facility on a full-time basis.
Accordingly, LTC facilities have neither a physician nor pharmacist present at all times to handle
day-to-day pharmaceutical management and dispensing. On-site LTC facility staff typically
include registered nurses, licensed practical nurses, and certified nursing assistants, as well as
physical, occupational, and speech therapists. These professionals perform most aspects of dayto-day patient care, but they typically are not independently authorized to prescribe or dispense
medications to LTC patients.16
Absent staff pharmacists or physicians, an LTC facility is not an “authorized trading
partner” that could lawfully order or obtain prescription drug products from a manufacturer,
wholesaler, or repackager. 17 Therefore, even if an LTC nursing facility wanted to purchase
prescription drug products from a manufacturer, wholesaler, or repackager, it is not permitted to
do so. In comparison, a state-licensed LTC pharmacy is an “authorized trading partner” that can
procure pharmaceuticals for dispensing under the Federal Food, Drug, and Cosmetic Act and
state pharmacy law.
Similarly, well-established controlled substance regulatory policies require that an
authorized dispenser must retain control over e-kit controlled substances within LTC facilities.
15
See, e.g., 211 Pa. Code § 211.9 (Program Standards for Long-Term Care Nursing Facilities/Pharmacy Services):
“Facility policies shall ensure that … [o]nly licensed pharmacists shall dispense medications for residents. Licensed
physicians may dispense medications to the residents that are in their care.”
16
See generally 42 C.F.R. § 483.60, 483.75. As a reminder, LTC residents are generally older and frailer than the
average beneficiary; in SNFs, NFs, and ALFs combined, each patient takes on average 10 to 12 medications per day.
Drug dispensing and management for such patients requires extraordinarily attentive management to ensure the safe,
accurate, and efficient administration of medications to residents, avoid medication mix-ups or administration
delays, and prevent both diversion and waste of products stored and administered in LTC facilities.
17
See, e.g., 21 U.S.C. §§ 360eee(2)-(3) and 360eee-1. See also 21 U.S.C. § 353(b)(1) (authorizing the dispensing
of prescription-restricted drugs only upon written or oral prescription of a practitioner licensed by law to administer
such drug, and deeming the act of dispensing a drug contrary to the provisions of that paragraph to render a drug
misbranded while held for sale).
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 10
For example, DEA has enabled the placement of e-kits containing controlled substances in nonDEA-registered LTC facilities, provided the facility follows procedures that delineate:

a DEA-registered source;

security safeguards for each e-kit;

responsibility for proper control and accountability within the LTC facility (including
a requirement that the LTC facility and the DEA-registered clinic, pharmacy, or
co-practitioner maintain complete and accurate records of the controlled substances
placed in the e-kit, the disposition of these controlled substances, and a requirement
for periodic physical inventories); and

specification of the emergency medical conditions under which the controlled
substances may be administered to patients in the LTC facility (including
requirements that medication be administered by authorized personnel only as
expressly authorized by the individual practitioner).18
LTC facilities also are required by 42 C.F.R. § 483.75(i) to designate a physician as
Medical Director, responsible for implementation of resident care policies and the coordination
of medical care in the facility. This is not, however, an attending physician role:
While medical directors also can serve as attending physicians for individual
patients, the roles and function of a medical director are separate from those of
an attending physician. The medical director’s role involves the coordination
of facility-wide medical care, while the attending physician’s role involves
primary responsibility for the medical care of individual residents.19
LTC facilities must ensure that the medical care of each resident is supervised by a
physician who assumes the principal obligation and responsibility to manage the resident’s
medical condition and who agrees to visit the resident as often as necessary to address resident
medical care needs. The frequency of visits, however, is appropriate to the resident’s medical
condition, stability, and recent and previous medical history, and must be no less than once every
30 days for the first 90 days after admission, and at least once every 60 days thereafter. The
arrangement does not establish an on-site physician with authority to manage and dispense
emergency medications for his own – let alone all – patients within an LTC facility.
18
DEA, Statement of Policy: Controlled Substances in Emergency Kits for Long Term Care Facilities (45 Fed. Reg.
24128; April 9, 1980).
19
CMS Manual System, Pub. 100-07 State Operations, Provider Certification, “Medical Director Guidance”
(Nov. 28, 2005) at 2 (emphasis added).
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 11
3. Why do e-kits have to involve repackaging? Have LTC facilities/pharmacies
approached 503B outsourcing facilities and/or FDA-registered commercial
repackagers to provide e-kit products? FDA is aware of some compounding
scenarios where 503B-compounded product was thought not to be available, but in
fact was available somewhere. Can FDA help with communication/publicity about
availability?
RESPONSE:
As documented in our prior written comments, repackagers may sometimes have unitdose medications available, but these are not commonly sold in volumes small enough to be
available to individual LTC pharmacies for use in e-kits. In addition, based on anecdotal
information that the SCPC previously provided to the agency, repackagers are reducing their
business of unit-dose repackaging in ways that might previously have been useful to LTC
pharmacies. As noted above, moreover, manufacturers, suppliers, and repackagers do not provide
unit dose medications in the special packaging that LTC pharmacies are required by law to
employ.20
LTC pharmacies also are typically only placing a few doses of commercially available
product (not compounded items) into an e-kit, and that small number of doses is replenished only
if and when a specific dose has been consumed during a patient emergency. Thus, the volume
requirements are very small, and an independent LTC pharmacy may require only a few unit
doses of a particular product during the course of a year. In current dispensing scenarios, for
example, a pharmacy might buy two stock bottles of 100 tablets, prepare 5 unit-dose quantities
for the e-kit, and retain the remaining 195 tablets available for routine prescription dispensing. It
would not be viable for a pharmacy to order, a minimum quantity from a repackager (probably
500-1000 tablets of a unit-dosed medication) solely for e-kit use. (These products typically are
not appropriate for non-e-kit dispensing. “Routine” dispensing for LTC patients typically must
be prepared in a different type of special packaging, such as a patient-specific 30-day supply
blister card.)
The other alternatives relative to repackaging for e-kits are:

20
Wait for an emergency to arise and then have the pharmacy dispense the prescribed,
emergency dose for a patient. This is not only inconsistent with applicable law and
CMS Conditions of Participation, it also would place patients at increased risk, due to
delay in the provision of emergency medication. In addition, it could well increase
re-hospitalization, because the resident might have to be transferred to a hospital
because he or she would receive emergency medications more quickly. In these
cases, the patient still would be at increased risk. The Medicare program would have
Due to the special packaging requirements imposed on LTC pharmacies regarding all medications dispensed to
patients in LTC facilities, the lack of manufacturers, suppliers, or repackagers that provide unit dose medications
that comply with these special packaging requirements also justifies LTC pharmacies “pre-packaging” or staging
commonly dispensed medications on-site.
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 12
to expend funds unnecessarily to pay for the readmission. In addition, hospitals are
liable to the Medicare program if their readmission rates are too high. Similar
penalties will be imposed on LTC nursing facilities in 2018.

Place an entire commercial package (e.g., bottle of 100 tablets) in an e-kit. As noted
above, however, e-kit laws typically allow only limited doses of particular drugs to be
held in e-kits (i.e., this approach likely would run afoul of state law). Even if this
were permissible under current state law, this approach also increases diversion risk
and waste of the extra product that would likely go unused before expiration.
Based on the foregoing, the Associations do not believe that FDA can do anything to
promote, communicate, or publicize FDA-registered commercial repackagers to produce very
limited quantities of unit-dosed medications that comply with LTC pharmacy special packaging
requirements for use in an e-kit.
IV.
CONCLUSION
The Associations have focused in large part in this letter on issues that FDA raised
specifically with regard to e-kits. We reiterate, however, that elements of FDA’s draft Guidance
on repackaging threaten other very important practices in the LTC pharmacy sector (e.g., ability
to prepackage and stage drug products for patient-specific dispensing in accordance with federal
and state pharmacy law, and the ability of LTC pharmacies to use remote dispensing technology
to more efficiently and effectively dispense medications to patents). Our prior comment letters
provide ample justification for FDA to modify its proposed repackaging guidance to avoid
jeopardizing these practices, all of which are well within the traditional professional practice of
pharmacy. We respectfully request that FDA expressly acknowledge the activities of LTC
pharmacies as “dispensing” for LTC patients. This is legally appropriate, and should help
resolve some of the implementation concerns that have arisen from the draft Guidances
published to date.
We thank you for your consideration of these comments, and welcome any further
questions that you may have.
Please feel free to contact me at 717.503.0516 or
arosenbloom@seniorcarepharmacies.org if you have any questions.
Sincerely,
Alan G. Rosenbloom
President and CEO
Senior Care Pharmacy Coalition
Letter to Julie Dohm, J.D., Ph.D.
July 15, 2016
Page 13
cc:
Docket No. FDA–2014–D–1524
Holly Harmon, RN, MBA, LNHA
Senior Director of Clinical Services
American Health Care Association
Peter Rankin
Director of Policy & Advocacy
American Society of Consultant Pharmacists