Current through September 24, 2024
1. Every home
health agency, hospice organization or business/location in this state subject
to regulation by the Mississippi Board of Pharmacy where certain prescription
drugs as approved by the Board are bought, maintained, administered or provided
directly to consumers, without the services of a pharmacist being required,
shall obtain a permit as a home health/hospice from the Mississippi Board of
Pharmacy.
2. To obtain a permit or
renew a permit for a home health/hospice, the applicant shall:
A. Submit a written application on a form
prescribed by the Board;
B. Submit
the required fees as follows:
Fifty dollars ($50.00) for the registration period January 1,
2012, through December 31, 2013, and each biennial registration period
thereafter.
Any home health/hospice permit renewal application postmarked
after December 31 of the renewal period shall be returned and a fifty dollar
($50.00) late renewal fee shall be assessed prior to renewal.
3. Every business issued a home
health/hospice permit by the Board shall renew this permit biennially. Newly
issued permits which do not coincide with the registration period shall be
valid for the following periods of time: If the permit is issued in the first
half of the registration period, it must be renewed at the end of the
registration period. If the permit is issued in the second half of the
registration period, it must be renewed at the end of the next registration
period.
4. The person who signs the
application for a home health/hospice permit or the renewal of a home
health/hospice permit shall be the permit holder for that facility and shall be
responsible for all activities in the permitted facility which are subject to
regulation by the Board. Once issued, a permit cannot be amended, transferred
or assigned to another person.
5.
If the employment of a permit holder is terminated or if for any other reason
he/she wishes to be relieved of the responsibilities of the permit holder,
he/she must return the home health/hospice permit to the Mississippi Board of
Pharmacy with written notice that he/she is no longer the permit holder for
that facility. When a permit is thus returned, application for a new permit for
that facility must be made to the Mississippi Board of Pharmacy within ten (10)
days.
6. If a permitted facility is
permanently closed or has a change of ownership, the permit holder for that
facility shall give notice to the Board of the effective date of closure or
change in ownership at least ten (10) days prior to the closure or change of
ownership.
7. If a permitted
facility has a change in name or location, a new permit must be obtained.
Application for this new permit must be made to the Board at least ten (10)
days prior to the change.
8. All
home health/hospices permitted by the Mississippi Board of Pharmacy shall
comply with the following:
A. Prescription
drugs that are bought or maintained, in a home health/hospice or provided to a
consumer from a home health/hospice shall be limited to those items authorized
by the Board. A list of the authorized prescription drugs shall be published by
the Board at least annually.
Items may be added to or deleted from the list by the Board at
any regularly called meeting. At any time a change in the list of authorized
drugs is made, the Board shall provide the changed list to all persons
registered with a home health/hospice permit.
B. A home health/hospice shall not buy,
maintain or provide to a consumer any prescription drug not authorized by the
Board of Pharmacy unless such prescription drug was obtained pursuant to the
valid prescription or order of a practitioner.
C. Delivery of any prescription drug to a
consumer shall be pursuant to a valid order of a practitioner who is authorized
to prescribe the drug. These orders shall be maintained for a period of six (6)
years.
D. A facility permitted with
a home health/hospice permit shall not sell or distribute a prescription drug
to any person who is not permitted or otherwise authorized to purchase
prescription drugs except that a facility permitted by the Board of Pharmacy
with a home health/hospice permit may supply these items to other facilities
under common control or ownership.
E. Complete and accurate records of
acquisition and disposition of all prescription drugs which are bought or
maintained by a home health/hospice shall be maintained for a period of six (6)
years. These records shall be readily retrievable and available for inspection
by agents of the Mississippi Board of Pharmacy.
F. Any prescription drug maintained in a home
health/hospice or provided to a consumer from a home health/hospice shall be
labeled so as to be in compliance with the labeling requirements of the Federal
Food and Drug Administration and any additional labeling necessary for the safe
and effective use of the product by the consumer.
G. Each home health/hospice where
prescription drugs are bought or maintained shall provide storage areas that
ensure proper lighting, ventilation, temperature, sanitation, humidity, space
and equipment. All prescription drugs shall be stored at appropriate
temperatures per label requirements or official United States Pharmacopeia
(USP) compendium requirements to ensure that the identity, strength, quality,
and purity of the products are not affected. If no temperature requirements are
listed, prescription drugs may be stored at room temperature as defined in the
USP. A separate storage area shall be provided for prescription drugs that are
deteriorated, outdated, misbranded, or otherwise adulterated.
H. Each home health/hospice shall employ
adequate personnel with the education and experience necessary to safely and
lawfully engage in the preparation, administration or delivery of prescription
drugs
I. Home health/hospices shall
be maintained in an orderly and sanitary fashion.
J. A permit shall not be issued for a home
health/hospice located in a residence.
K. The Board of Pharmacy may refuse to issue
or renew, or may suspend, revoke or restrict the permit of any home
health/hospice under the applicable provisions of Article IX of these
regulations.
9. For
purposes of these regulations the following definitions shall apply:
A. "Home health/hospice" shall mean a
business, which does not require the services of a pharmacist, where certain
prescription drugs are bought, maintained or provided to consumers.
B. "Home Health Agency" shall mean a public
or privately owned agency or organization or a subdivision of such agency or
organization, properly authorized to conduct business in Mississippi, which is
primarily engaged in providing to individuals, at the written direction of a
licensed physician, in the individual's place of resident, skilled nursing
services provided by or under the supervision of a registered nurse licensed to
practice in Mississippi.
C.
"Hospice" shall mean an autonomous, centrally administered,
medically directed, nurse
coordinated program providing palliative and supportive care to meet the
special needs arising out of the physical, emotional, spiritual, social and
economic stresses which are experienced during the final stages of illness and
during dying and bereavement. This care is available twenty-four (24) hours a
day, seven (7) days a week, and is provided on the basis of need regardless of
inability to pay.
D. "Prescription
Drug" or "Legend Drug" shall mean a drug which is required under federal law to
be labeled with either of the following statements prior to being dispensed or
delivered:
(1) "Caution: Federal law
prohibits dispensing without prescription," or
(2) "Rx Only", or
(3) "Caution: Federal law restricts this drug
to use by or on the order of a licensed veterinarian"; or a drug which is
required by any applicable federal or state law or regulation to be dispensed
on prescription only or is restricted to use by practitioners only.
