Current through Register Vol. 35, No. 18, September 24, 2024
A.
"Adulterated" a drug or device shall be deemed to be adulterated
if it:
(1) consists in whole or part of any
filthy, putrid, or decomposed substance;
(2) has been produced, prepared, packed or
held under unsanitary conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to health;
(3) is a drug and the methods used in or the
facilities of controls used for its manufacture, processing, packing or holding
do not conform to or are not operated or administered in conformity with
current good manufacturing practice to assure that such drug meets the
requirements of the New Mexico Drug, Device and Cosmetic Act (this article) as
to safety and has the identity and strength and meets the quality and purity
characteristics which purports or is represented to possess;
(4) is a drug and its container is composed
in whole or part of any poisonous or deleterious substance which may render the
contents injurious to health;
(5)
is a drug and it bears or contains for purposes of coloring only a color
additive which is unsafe within the meaning of the Federal Act or it is a color
additive the intended use of which in drugs is for the purpose of coloring only
and is unsafe within the meaning of the Federal Act;
(6) purports to be or is represented as a
drug the name of which is recognized in an official compendium and its strength
differs from or its quality or purity falls below the standard set forth in
such compendium; such determination as to strength, quality and purity shall be
made in accordance with the tests or methods of assay set forth in such
compendium or in the absence of or inadequacy of such rests or methods of
assay, those prescribed under the authority of the Federal Act; no drug defined
in an official compendium shall be deemed to be adulterated under this
paragraph because it differs from the standard of strength, quality or purity
therefore set forth if such standard is plainly stated on its label; whenever a
drug is recognized both in the United States pharmacopoeia and the homeopathic
pharmacopoeia of the United States it shall be subject to the requirements of
the United States pharmacopoeia unless it is labeled and offered for sale as a
homeopathic drug, in which case it shall be subject to the provisions of the
homeopathic pharmacopoeia of the United States and not those of the United
States pharmacopoeia;
(7) is not
subject to the provisions of Paragraph (6) of this subsection and its strength
differs from or its purity or quality falls below that which it purports or is
represented to possess;
(8) is a
drug and any substance has been mixed or packed therewith so as to reduce its
quality or strength or substituted wholly or in part therefore.
B.
"Affiliate" means
a business entity that has a relationship with a second business entity if,
directly or indirectly:
(1) one business
entity controls, or has the power to control, the other business entity;
or
(2) a third-party controls, or
has the power to control, both of the business entities
C.
"Authorized" means:
(1) in the case of a manufacturer or
repackager, having a valid registration as a drug establishment with the FDA
under Section 510 of the Federal Act;
(2) a licensed wholesale distributor, who is
compliant with the licensure reporting requirements under section 503(e) of the
Federal Act;
(3) a licensed
third-party logistics provider, who is compliant with the licensure reporting
requirements under section 584(b) of the Federal Act;
(4) in the case of a dispenser, having a
valid license under New Mexico state law.
D.
"Blood" means the whole blood
collected from a single donor and processed either for transfusion or further
manufacturing.
E.
"Blood
component" means that part of blood separated by physical or mechanical
means.
F.
"Co-licensed
partner or product" means an instance where two or more parties have the
right to engage in the manufacturing or marketing of a prescription drug,
consistent with FDA's implementation of the Drug Supply Chain Security Act
(DSCSA).
G.
"Common
carrier" means any person or entity who undertakes, whether directly or
by any other arrangement, to transport property including prescription drugs
for compensation.
H.
"Counterfeiting" means engaging in activities that create a
counterfeit drug.
I.
"Counterfeit drug" means a drug that is deliberately and
fraudulently mislabeled with respect to its identity, ingredients or sources.
Types of such pharmaceutical counterfeits may include:
(1) identical copies: which are counterfeits
made with the same ingredients, formulas and packaging as the originals but not
made by the original manufacturer;
(2) look-alikes: which feature high-quality
packaging and convincing appearances but contain little or no active
ingredients and may contain harmful substances;
(3) rejects: which are drugs that have been
rejected by the manufacturer for not meeting quality standards;
(4) re-labels: which have passed their
expiration dates or have been distributed by unauthorized foreign sources and
may include placebos created for late-phase clinical trials.
J.
"Counterfeit prescription
drug" means a dangerous drug which, or the container or labeling of
which, without authorization:
(1) bears the
trademark, trade name, or other identifying mark, print, device, or any
likeness thereof, of a drug manufacturer, processor, packer, or distributor
other than the person or persons who in fact manufactured, processed, packaged,
or distributed such drug and which thereby falsely purports or is represented
to be the product of, or to have been packed or distributed by such other drug
manufacturer, processor, packer, or distributor;
(2) from the original manufacturer is an
imitation of another dangerous drug or has been deliberately mislabeled (for
example, as to its strength or expiration date) but it shall not include a
dangerous drug or placebo intended for use in a clinical trial that is
intentionally labeled or marked to maintain proper blinding of the
study.
K.
"Dangerous drug" also known as a "prescription drug" means a drug
other than a controlled substance enumerated in Schedule I of the Controlled
Substance Act, that because of potentiality for harmful effect or the method of
its use or the collateral measures necessary to its use is not safe except
under the supervision of a practitioner licensed by law to direct the use of
such drug and hence for which adequate directions for use (directions under
which the layman can use a drug or device safely and for the purposes for which
intended) cannot be prepared. A drug shall be dispensed only upon the
prescription of a practitioner licensed by law to administer or prescribe the
drug if it:
(1) is a habit-forming drug and
contains any quantity of a narcotic or hypnotic substance or a chemical
derivative of such substance that has been found under the Federal Act and the
board to be habit-forming;
(2)
because of its toxicity or other potential for harmful effect or the method of
its use or the collateral measures necessary to its use is not safe for use
except under the supervision of a practitioner licensed by law to administer or
prescribe the drug;
(3) is limited
by an approved application by Section 505 of the Federal Act to the use under
the professional supervision of a practitioner licensed by law to administer or
prescribe the drug;
(4) bears the
legend "Caution: federal law prohibits dispensing without
prescription";
(5) bears the legend
"Caution: federal law restricts this drug to use by or on the order of a
licensed veterinarian";
(6) bears
the legend "RX only"; or
(7) has
been declared a dangerous drug by the board of pharmacy.
L.
"Designated representative"
means an individual designated by the wholesale distributor, third-party
logistics provider, or repackager who will serve as the responsible individual
of the wholesale distributor, third-party logistics provider, or repackager
with the board who is actively involved in and aware of the actual daily
operation of the wholesale distributor, third-party logistics provider, or
repackager. The designated representative is responsible for all aspects of the
facility operations.
M.
"Dispenser" means:
(1) a retail
pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership
and control that do not act as a wholesale distributor, or other person
authorized by law to dispense or administer prescription drugs, and the
affiliated warehouses or distribution centers of such entities under common
ownership and control that do not act as a wholesale distributor; and
(2) does not include a person who dispenses
only products to be used in animals in accordance with Section 512(a)(5) of the
Federal Act.
N.
"Disposition" with respect to a product within the possession or
control of an entity, means the removal of such product from the pharmaceutical
distribution supply chain, which may include disposal or return of the product
for disposal or other appropriate handling and other actions, such as retaining
a sample of the product for further additional physical examination or
laboratory analysis of the product by a manufacturer or regulatory or law
enforcement agency.
O.
"Distribute or distribution" means the sale, purchase, trade,
delivery, handling, storage, or receipt of a product, and does not include the
dispensing of a drug pursuant to a prescription.
P.
"Drug" means articles:
(1) recognized as drugs in any official
compendium or supplement thereto, designated from time to time by the board for
use in the diagnosis, cure, mitigation, treatment or prevention of disease in
humans or other animals;
(2)
intended for use in the diagnosis, cure, mitigation, treatment or prevention of
disease in humans or other animals;
(3) other than food, intended to affect the
structure or any function of the body of humans or other animals;
(4) intended for use as a component of any
articles specified in Paragraphs (1), (2), (3) or (4) of this subsection
.
Q.
"Drug
sample" means a unit of a prescription drug that is not intended to be
sold and is intended to promote the sale of the drug as defined by the
Prescription Drug Marketing Act of 1987.
R.
"DSCSA" means the Drug Supply
Chain Security Act.
S.
"Emergency medical reasons" include, but are not limited to:
(1) the transfer or sales by a pharmacy to
nearby emergency medical services, i.e. ambulance companies and firefighting
organizations in the same state or same marketing or service area or nearby
licensed practitioners of prescription drugs for use in the treatment of
acutely ill or injured persons, consistent with the DSCSA and successor FDA
regulations;
(2) the provision of
minimal emergency supplies of prescription drugs by a pharmacy to nearby
nursing homes for use in emergencies or during hours of the day when necessary
prescription drugs cannot be obtained;
(3) the transfer or sale of naloxone by a
dispenser for rescue use in accordance with Section
24-23-1
NMSA 1978 of the Public Health Act;
(4) the transfer or sale of a drug pursuant
to a specific patient need.
T.
"Exclusive distributor" means
the wholesale distributor that directly purchased the product from the
manufacturer and is the sole distributor of that manufacturer's product to a
subsequent repackager, wholesale distributor, or dispenser.
U.
"Facility" means facility of
a wholesale distributor, repackager, or third-party logistics provider where
prescription drugs are stored, handled, repackaged or offered for
sale.
V.
"FDA" means
food and drug administration, a federal agency within the United States
department of health and human services, established to set safety and quality
standards for drugs, food, cosmetics and other consumer products.
W.
"Federal Act" means the
Federal Food, Drug and Cosmetic Act.
X.
"Homogeneous case" means a
sealed case containing only product that has a single NDC number belonging to a
single lot.
Y.
"Illegitimate
product" means a product for which credible evidence shows that the
product:
(1) is counterfeit, diverted, or
stolen;
(2) is intentionally
adulterated such that the product would result in serious adverse health
consequences or death to humans;
(3) is the subject of a fraudulent
transaction; or
(4) appears
otherwise unfit for distribution such that the product would be reasonably
likely to result in serious adverse health consequences or death to humans.
Z.
"Immediate
container" means a container and does not include package
liners.
AA.
"Licensed"
means:
(1) in the case of a wholesale
distributor:
(a) having valid licensure with
the board; and
(b) for facilities
located outside of New Mexico:
(i) having
valid licensure by the state from which the drug is distributed; or
(ii) if the state from which the drug is
distributed has not established a licensure requirement, is licensed by the FDA
(beginning at such time as federal regulations are promulgated to implement
Section 583 of the Federal Act).
(2) in the case of a third-party logistics
provider:
(a) for facilities located outside
of New Mexico:
(i) having valid licensure by
the state from which the drug is distributed when required by that state; and
(ii) having a valid registration
with the FDA (beginning at such time as federal regulations are promulgated to
implement Section 584 of the Federal Act), unless the FDA has made a finding
that the third-party logistics provider does not utilize good handling and
distribution practices and publishes notice thereof; or
(iii) having valid licensure with the
board.
(b) for
facilities located in New Mexico: having valid licensure with the
board.
BB.
"Manufacturer" means:
(1) a
person that holds an application approved under Section 505 of the Federal Act
or a license issued under Section 351 of the Federal Public Health Service Act
for such drug, or if such drug is not the subject of an approved application or
license, the person who manufactured the drug;
(2) a co-licensed partner of the person
described in Paragraph (1) that obtains the drug directly from a person
described in Paragraph (1) or (3) of this subsection; or
(3) an affiliate of a person described in
Paragraph (1) or (2) of this subsection that receives the product directly from
a person described in Paragraph (1) or (2) of this subsection.
CC.
"Manufacturing"
means the production, preparation, propagation, conversion or processing of a
drug or device, either directly or indirectly, by extraction from substances of
natural origin or independently by means of chemical or biological synthesis;
and includes packaging or repackaging, labeling or relabeling and the promotion
and marketing of such drugs or devices; also included is the preparation and
promotion of commercially available products from bulk compounds for resale by
pharmacies, licensed practitioners or other persons.
DD.
"Misbranded" means a label
to an article that is misleading. In determining whether the label is
misleading there shall be taken into account, among other things, not only
representations made or suggested by statement, word, design, device or any
combination of the foregoing, but also the extent to which the label fails to
reveal facts material in the light of such representations or material with
respect to consequences that may result from the use of the article to which
the label relates under the conditions of use prescribed in the label or under
such conditions of use as are customary or usual.
EE.
"NDC" means national drug
code.
FF.
"Official
compendium" means the official USP-NF or the official homeopathic
pharmacopoeia of the United States or any supplement to either of
them.
GG.
"Package"
means the smallest individual saleable unit of product for distribution by a
manufacturer or repackager that is intended by the manufacturer for ultimate
sale to the dispenser of such product. An individual saleable unit is the
smallest container of product introduced into commerce by the manufacturer or
repackager that is intended by the manufacturer or repackager for individual
sale to a dispenser.
HH.
"Prescription drug" means any human drug required by federal or
state law or regulation to be dispensed only by a prescription, including
finished dosage forms and active ingredients subject to Section 503(b) of the
Federal Food, Drug and Cosmetic Act.
II.
"Product" means a
prescription drug in a finished dosage form for administration to a patient
without substantial further manufacturing (such as capsules, tablets, and
lyophilized products before reconstitution), but does not include:
(1) blood or blood components intended for
transfusion;
(2) radioactive drugs
or radioactive biological products (as defined in Section 600.3(ee) of title
21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory
Commission or by the state pursuant to an agreement with such commission under
Section 274 of the Atomic Energy Act of 1954 (
42 U.S.C.
2021);
(3) imaging drugs;
(4) an intravenous product described in
Paragraph (14), (15), or (16) of definition XX. ("transaction");
(5) any medical gas as defined in Section 575
of the Federal Act;
(6) homeopathic
drugs marketed in accordance with applicable guidance under the federal act;
or
(7) a drug compounded in
compliance with Section 503A or 503B of the Federal Act.
JJ.
"Product identifier" means a
standardized graphic that includes, in both human-readable form and on a
machine-readable data carrier that conforms to the standards developed by a
widely recognized international standards development organization, the
standardized numerical identifier, lot number, and expiration date of the
product, meeting the requirements of the DSCSA.
KK.
"Product tracing information"
means, for each transaction: the recorded transaction history,
transaction information, and transaction statement meeting the requirements of
the DSCSA.
LL.
"Quarantine" means the storage or identification of a product, to
prevent distribution or transfer of the product, in a physically separate area
clearly identified for such use or through other procedures.
MM.
"Repackage" means
repackaging or otherwise changing the container, wrapper or labeling to further
the distribution of a prescription drug excluding that completed by the
pharmacists responsible for dispensing product to the patient.
NN.
"Repackager" means a person
who owns or operates a facility that repackages and re-labels a product or
package for:
(1) further sale; or
(2) distribution without a further
transaction.
OO.
"Return" means providing product to the authorized immediate
trading partner from which such product was purchased or received, or to a
returns processor or reverse logistics provider for handling of such product.
PP.
"Returns processor or
reverse logistics provider" means a person who owns or operates an
establishment that dispositions or otherwise processes saleable or non-saleable
product received from an authorized trading partner such that the product may
be processed for credit to the purchaser, manufacturer, or seller or disposed
of for no further distribution.
QQ.
"Selling of drugs, devices or
cosmetics" shall be considered to include the manufacture, production,
processing, packing, exposure, offer, possession and holding of any such
article for sale and the sale and the sale and the supplying or applying of any
such article in the conduct of a drug or cosmetic establishment.
RR.
"Significant loss" means any
loss of a prescription drug that exceeds a reasonable level established by like
persons which requires that loss to be reported to the board or as required by
the DEA or other state or federal agencies for prescription drugs and
controlled substances.
SS.
"Specific patient need" means the transfer of a product from one
pharmacy to another to fill a prescription for an identified patient. Such term
does not include the transfer of a product from one pharmacy to another for the
purpose of increasing or replenishing stock in anticipation of a potential
need.
TT.
"Standardized
numerical identifier" means a set of numbers or characters used to
uniquely identify each package or homogenous case that is composed of the NDC
that corresponds to the specific product (including the particular package
configuration) combined with a unique alphanumeric serial number of up to 20
characters.
UU.
"Suspect
product" means a product for which there is reason to believe:
(1) is potentially counterfeit, diverted, or
stolen;
(2) is potentially
intentionally adulterated such that the product would result in serious adverse
health consequences or death to humans;
(3) is potentially the subject of a
fraudulent transaction; or
(4)
appears otherwise unfit for distribution such that the product would result in
serious adverse health consequences or death to humans.
VV.
"Third-party logistics
provider" means an entity that provides or coordinates warehousing, or
other logistics services of a product in interstate commerce on behalf of a
manufacturer, wholesale distributor, or dispenser of a product, but does not
take ownership of the product, nor have responsibility to direct the sale or
disposition of the product.
WW.
"Trading partner" means:
(1) a
manufacturer, repackager, wholesale distributor, or dispenser from whom a
manufacturer, repackager, wholesale distributor, or dispenser accepts direct
ownership of a product or to whom a manufacturer, repackager, wholesale
distributor, or dispenser transfers direct ownership of a product; or
(2) a third-party logistics provider from
whom a manufacturer, repackager, wholesale distributor, or dispenser accepts
direct possession of a product or to whom a manufacturer, repackager, wholesale
distributor, or dispenser transfers direct possession of a product.
XX.
"Transaction"
means the transfer of product between persons in which a change of ownership
occurs, but does not include:
(1)
intracompany distribution of any product between members of an affiliate or
within a manufacturer;
(2) he
distribution of a product among hospitals or other health care entities that
are under common control; for the purposes of this section "common control"
means the power to direct or cause the direction of the management and policies
of a person or an organization, whether by ownership of stock, voting rights,
by contract, or otherwise;
(3) the
distribution of a product for emergency medical reasons including a federal or
state declared public health emergency, except that a drug shortage not caused
by a public health emergency shall not constitute an emergency medical
reason;
(4) the dispensing of a
product pursuant to a prescription executed in accordance with Section
503(b)(1) of the Federal Act;
(5)
the distribution of product samples by a manufacturer or a licensed wholesale
distributor in accordance with Section 503(d) of the Federal Act;
(6) the distribution of blood or blood
components intended for transfusion;
(7) the distribution of minimal quantities of
product by a licensed retail pharmacy to a licensed practitioner for office
use;
(8) the sale, purchase, or
trade of a drug or an offer to sell, purchase, or trade a drug by a charitable
organization described in Section 501(c)(3) of the Internal Revenue Code of
1986 to a nonprofit affiliate of the organization to the extent otherwise
permitted by law;
(9) the
distribution of a product pursuant to the sale or merger of a pharmacy or
pharmacies or a wholesale distributor or wholesale distributors, except that
any records required to be maintained for the product shall be transferred to
the new owner of the pharmacy or pharmacies or wholesale distributor or
wholesale distributors;
(10) the
dispensing of an approved animal drug product approved under Section 512(c) of
the Federal Act;
(11) products
transferred to or from any location that is licensed by the Nuclear Regulatory
Commission or by the state pursuant to an agreement with such commission under
Section 274 of the Atomic Energy Act of 1954 (
42 U.S.C.
2021);
(12) a combination product that is not
subject to approval under Section 505 or licensure under Section 351 of the
Public Health Service Act, and that is:
(a) a
product comprised of a device and one or more other regulated components (such
as a device and a drug, biologic, or drug and biologic) that are physically,
chemically, or otherwise combined or mixed and produced as a single
entity;
(b) two or more separate
products packaged together in a single package or as a unit and comprised of a
drug and device or device and biological product; or
(c) two or more finished medical devices plus
one or more drug or biological products that are packaged together in what is
referred to as a "medical convenience kit" as described in Paragraph (13)
below;
(13) the
distribution of a collection of finished medical devices, which may include a
product or biological product, assembled in kit form strictly for the
convenience of the purchaser or user (referred to in this paragraph as a
"medical convenience kit") if:
(a) the
medical convenience kit is assembled in an establishment that is registered
with the FDA as a device manufacturer in accordance with Section 510(b)(2) of
the Federal Act;
(b) the medical
convenience kit does not contain a controlled substance that appears in a
schedule contained in the Comprehensive Drug Abuse Prevention and Control Act
of 1970;
(c) in the case of a
medical convenience kit that includes a product, the person that manufacturers
the kit:
(i) purchased such product directly
from the pharmaceutical manufacturer or from a wholesale distributor that
purchased the product directly from the pharmaceutical manufacturer;
and
(ii) does not alter the primary
container or label of the product as purchased from the manufacturer or
wholesale distributor; and
(d) in the case of a medical convenience kit
that includes a product, the product is:
(i)
an intravenous solution intended for the replenishment of fluids and
electrolytes;
(ii) a product
intended to maintain the equilibrium of water and minerals in the
body;
(iii) a product intended for
irrigation or reconstitution;
(iv)
an anesthetic;
(v) an
anticoagulant;
(vi) a vasopressor;
or
(vii) a
sympathomimetic;
(14) the distribution of an intravenous
product that, by its formulation, is intended for the replenishment of fluids
and electrolytes (such as sodium, chloride, and potassium) or calories (such as
dextrose and amino acids);
(15) the
distribution of an intravenous product used to maintain the equilibrium of
water and minerals in the body, such as dialysis solutions;
(16) the distribution of a product that is
intended for irrigation, or sterile water, whether intended for such purposes
or for injection;
(17) the
distribution of a medical gas (as defined in Section 575 of the Federal Act);
or
(18) the distribution or sale of
any licensed product under section 351 of the Public Health Service Act that
meets the definition of a medical device under Section 201(h) of the Federal
Act.
YY.
"Transaction history" means a statement in paper or electronic
form, including the transaction information for each prior transaction going
back to the manufacturer of the product.
ZZ.
"Transaction information"
means:
(1) the proprietary or established name
or names of the product;
(2) the
strength and dosage form of the product;
(3) the NDC number of the product;
(4) the container size;
(5) the number of containers;
(6) the lot number of the product;
(7) the date of the transaction;
(8) the date of the shipment, if more than 24
hours after the date of the transaction;
(9) the business name and address of the
person from whom ownership is being transferred; and
(10) the business name and address of the
person to whom ownership is being transferred.
AAA.
"Transaction statement"
means a statement, in paper or electronic form, that the entity transferring
ownership in a transaction:
(1) is authorized
as required under the DSCSA;
(2)
received the product from a person that is authorized as required under the
DSCSA;
(3) received transaction
information and a transaction statement from the prior owner of the product, as
required under Section 582 of the Federal Act;
(4) did not knowingly ship a suspect or
illegitimate product;
(5) had
systems and processes in place to comply with verification requirements under
Section 582 of the Federal Act;
(6)
did not knowingly provide false transaction information; and
(7) did not knowingly alter the transaction
history.
BBB.
"USP-NF standards" means standards published in the current
official United States Pharmacopeia-National Formulary.
CCC.
"Verification or verify"
means determining whether the product identifier affixed to, or imprinted upon,
a package or homogeneous case corresponds to the standardized numerical
identifier or lot number and expiration date assigned to the product by the
manufacturer or the repackager, as applicable in accordance with Section 582 of
the Federal Act?
DDD.
"Wholesale drug distribution" means the distribution of a
prescription drug to a person other than a consumer or patient, or receipt of a
prescription drug by a person other than the consumer or patient, but does not
include:
(1) intracompany distribution of any
drug between members of an affiliate or within a manufacturer;
(2) the distribution of a drug, or an offer
to distribute a drug among hospitals or other health care entities which are
under common control;
(3) the
distribution of a drug or an offer to distribute a drug for emergency medical
reasons, including a federal or state declared public health emergency, except
that, a drug shortage not caused by a public health emergency shall not
constitute an emergency medical reason;
(4) the dispensing of a drug pursuant to a
prescription;
(5) the distribution
of minimal quantities of drug by a licensed retail pharmacy to a licensed
practitioner for office use;
(6)
the distribution of a drug or an offer to distribute a drug by a charitable
organization to a nonprofit affiliate of the organization to the extent
otherwise permitted by law;
(7) the
purchase or other acquisition by a dispenser, hospital, or other health care
entity of a drug for use by such dispenser, hospital, or other health care
entity;
(8) the distribution of a
drug by the manufacturer of such drug;
(9) the receipt or transfer of a drug by an
authorized third-party logistics provider provided that such third-party
logistics provider does not take ownership of the drug;
(10) a common carrier that transports a drug,
provided that the common carrier does not take ownership of the drug;
(11) the distribution of a drug, or an offer
to distribute a drug by an authorized repackager that has taken ownership or
possession of the drug and repacks it in accordance with Section 582(e) of the
Federal Act;
(12) saleable drug
returns when conducted by a dispenser;
(13) the distribution of a collection of
finished medical devices, which may include a product or biological product,
assembled in kit form strictly for the convenience of the purchaser or user
(referred to as a "medical convenience kit") if:
(a) the medical convenience kit is assembled
in an establishment that is registered with the FDA as a device manufacturer in
accordance with Section 501(b)(2) of the federal act;
(b) the medical convenience kit does not
contain a controlled substance that appears in a schedule contained in the
Comprehensive Drug Abuse Prevention and Control Act of 1970;
(c) in the case of a medical convenience kit
that includes a product, the person that manufacturers the kit:
(i) purchased such product directly from the
pharmaceutical manufacturer or from a wholesale distributor that purchased the
product directly from the pharmaceutical manufacturer; and
(ii) does not alter the primary container or
label of the product as purchased from the manufacturer or wholesale
distributor; and
(d) in
the case of a medical convenience kit that includes a product, the product is
(i) an intravenous solution intended for the
replenishment of fluids and electrolytes;
(ii) a product intended to maintain the
equilibrium of water and minerals in the body;
(iii) a product intended for irrigation or
reconstitution;
(iv) an
anesthetic;
(v) an
anticoagulant;
(vi) a vasopressor;
or
(vii) a
sympathomimetic;
(14) the distribution of an intravenous drug
that, by its formulation, is intended for the replenishment of fluids and
electrolytes (such as sodium, chloride, and potassium) or calories (such as
dextrose and amino acids);
(15) the
distribution of an intravenous drug used to maintain the equilibrium of water
and minerals in the body, such as dialysis solutions;
(16) the distribution of a drug that is
intended for irrigation, or sterile water, whether intended for such purposes
or for injection;
(17) the
distribution of medical gas, as defined in Section 575 of the Federal
Act;
(18) facilitating the
distribution of a product by providing solely administrative services,
including processing of orders and payments; or
(19) the transfer of a product by a hospital
or other health care entity, or by a wholesale distributor or manufacturer
operating at the direction of the hospital or other health care entity, to a
repackager described in Section 581(16)(B) and registered under Section 510 of
the Federal Act for the purpose of repackaging the drug for use by that
hospital, or other health care entity and other health care entities that are
under common control, if ownership of the drug remains with the hospital or
other health care entity at all times.
EEE.
"Wholesale distributor"
means a person or entity (other than a manufacturer, a manufacturer's
co-licensed partner, a third-party logistics provider, or repackager) engaged
in wholesale drug distribution.
