New Mexico MPJE Study Guide (Master Exam)

When can you release an individual’s prescription records for court cases?
● You are allowed to share an individual’s prescription records if you have received a ​court order​.
Simply look to see if a judge has signed the order. Even with a court order, you may only disclose
the information specifically described in the order. On occasion, you may also receive a request
for someone’s prescription records in the form of a subpoena, often from an attorney’s office. In
these situations, you need to be very careful. A subpoena issued by someone other than a judge,
such as an attorney, is different from a court order.
● A pharmacy may disclose information to a party issuing a subpoena only if certain conditions are
met. Before responding to the subpoena, the pharmacy should receive evidence that there were
reasonable efforts to notify the person whose records are being sought ​so the person has a
chance to object to the disclosure or seek a qualified protective order for the information
from the court​. A qualified protective order would be a stipulation by both parties that the
records being sought would be used for the sole purpose of the litigation, and then either
destroyed or returned at the end of the proceedings. Several pharmacy chains have been
heavily fined due to some of their pharmacists, however well-intentioned, providing patient
prescription records solely on the basis of subpoenas.
● 45 C.F.R $ 164.512 (e).

Which of the following products would be exempt from the provisions of the tamper-evident
packaging regulation?
● The relevant portion of the regulations regarding exceptions to the tamper-evident packaging
requirements states:
● “The Food and Drug Administration has the authority under the Federal Food, Drug, and
Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging
of OTC drug products that will improve the security of OTC drug packaging and help assure the
safety and effectiveness of OTC drug products. An OTC drug product (except a dermatological,
dentifrice, insulin, or ​lozenge product​) for retail sale that is not packaged in a tamper-resistant
package or that is not properly labeled under this section is adulterated under section 501 of the
act or misbranded under section 502 of the act, or both.”
● The requirement for tamper-evident packaging also applies to cosmetic liquid oral hygiene
products and vaginal products (21 CFR 700.25) and contact lens solutions and tablets used to
make these solutions (21 CFR 800.12).
● See 21 CFR §211.132 for a further discussion of the actual packaging and labeling requirements.
● References
1. 21 CFR §211.132.
2. 21 CFR 800.12.
3. 21 CFR 700.25.
Which of the following agencies is responsible for enforcing HIPAA?
● At first blush, you may not think that the ​Office of Civil Rights​ would be the agency for enforcing
HIPAA or where individuals can make a complaint when they feel their privacy rights are
violated. However, that is the case. For a complete look at the responsibilities of the
organization, visit the website below. When HIPAA was first enacted, the Office of Civil Rights
would only typically respond to complaints dealing with purported privacy violation; however,
the office is now taking a much more proactive stance in checking compliance with the HIPAA
Privacy and Security regulations.

A drug facts panel is required to contain which of the following?

● The list below incorporates the headings that need to be included on a drug facts panel which
you are likely familiar with from purchasing over the counter products. Note that an ​NDC
number is not required​ on either an OTC label or a prescription drug label, but is highly
recommended.
● Drug Facts Panel
● Active Ingredients (including ​dosage unit and quantity per dosage unit​)
● Purpose (e.g. antihistamine)
● Use(s), Indications (e.g., sneezing, runny nose)
● Warnings ​(examples):
■ external, vaginal, or rectal use only
■ do not use (contraindications)
■ ask doctor before using (list of applicable conditions)
■ ask doctor or pharmacist (applicable drug-drug, drug-food interactions)
■ when using (side effects and what to avoid)
■ stop using (signs of toxicity)
■ if pregnant or breast-feeding warning
■ keep out of reach of children and accidental overdose warning
● Directions
● Other information (as required by the monograph, regulation or approved labeling
● Inactive Ingredients
● Questions? (Optional), followed by telephone number
● See 21 CFR § 201.66 for a complete discussion of the requirement and actual graphics of what a
drug facts panel looks like.

What is/are true regarding the Kefauver-Harris Amendments?

● In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C
Act. The legislation was passed largely in response to the thalidomide tragedy, which resulted in
the birth of thousands of malformed babies in Western Europe. The birth defect was called
phocomelia and created flipper-like appendages instead of arms and legs. Thalidomide had been
marketed as a sleeping pill. Some of the major changes enacted with the legislation:
 ● Required that manufacturers prove the effectiveness of drug products before they go on
the market and afterward report any serious side effects
● Required that evidence of effectiveness be based on adequate and well-controlled
clinical studies conducted by qualified experts. Study subjects would be required to give
their informed consent.
● Gave FDA 180 days to approve a new drug application, and required FDA approval
before the drug could be marketed in the United States
● Mandated that FDA conduct a retrospective evaluation of the effectiveness of drugs
approved for safety, but not for effectiveness, between 1938 and 1962
● Allowed FDA to set good manufacturing practices for the industry, and mandated
regular inspections of production facilities
● Transferred to FDA control of prescription drug advertising, which would have to include
accurate information about side effects

Statements regarding NDC numbers:

● Many pharmacists believe that NDC numbers are required on prescription and over-the-counter
products and that an NDC number signifies that a drug has been approved by the FDA. However,
that is not the case. NDC numbers are highly recommended, but not mandated to be placed on
drug packaging.
● NDC numbers are assigned by the FDA for administrative purposes, and there is no correlation
between an NDC number and drug approval. In fact, it is considered a misbranding offense if an
NDC number is used to denote or imply an FDA approval of a drug. On the other hand, according
to the FDA Guidance Document on Bar Coding, manufacturers, repackers, re-labelers, and
private label distributors of human prescription drug products, biological products, and
over-the-counter drug products that are ​dispensed pursuant to an order and are commonly
used in hospitals ​are subject to the barcode requirement, which requires (at a minimum) the
inclusion of the NDC number.

Assume that you have just been licensed as a pharmacist in another state but have not started
working as a pharmacist yet. You hear on the news that there has been devastating flooding in this
jurisdiction that has severely hampered the delivery of pharmaceutical services, and you are anxious
to assist. Which of the following is/are applicable to emergency provisions in this jurisdiction that will
allow you to do that?

● In an emergency situation, the board may grant an emergency temporary pharmacist license to
practice in NM to a pharmacist who holds a license to practice pharmacy in another state. The
applicant must hold a current pharmacist license in another state that is not in any way
restricted (e.g., suspended, revoked, canceled, surrendered, etc.) and must also be sponsored by
a pharmacy with an active license in NM.
● The application is pretty straightforward and requests basic information, such as:
○ name, address, and phone number of the applicant
 ○ name and license number of the pharmacist-in-charge of the sponsoring pharmacy
○ name and license number of the sponsoring pharmacy
● The emergency temporary pharmacist license shall be valid for a period as determined by the
executive director of the board (not to exceed 6 months)​, who may renew the license for an
additional 6 months if the emergency situation still exists. Once the application is approved, the
board notifies the sponsoring pharmacy, and the pharmacist is restricted to practice in the
sponsoring pharmacy.
● NMAC 16.19.31.8

Activities may lead to the revocation or suspension of a DEA registration

● Under the Controlled Substance Act, the DEA has the authority to deny, suspend, or revoke a
DEA registration​ upon a finding that the registrant:
○ has materially falsified the application
○ has been convicted of a felony relating to a controlled substance or a List I chemical*
○ had a state license or registration suspended, revoked, or denied (or recommended to
be)
○ has committed an act which would render the DEA registration inconsistent with the
public interest
○ has been excluded (or directed to be excluded) from participation in a Medicare or
Medicaid program
● Another important consideration is that before revoking or suspending any registration, the DEA
is required to issue an ​Order to Show Cause​, which means that the registrant has an
opportunity for a hearing and is given the opportunity to explain why the registration should not
be revoked or suspended.
● *A List I chemical means a chemical specifically designated by the DEA Administrator that, in
addition to legitimate uses, is used in manufacturing a controlled substance in violation of the
act and is important to the manufacture of a controlled substance.
● Title 21 United States Code §824.
● 21 CFR §1301.36.
● 21 CFR §1300.02.

OTC drugs can be marketed under what?

● Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the
New Drug Application (NDA)​ Process. Under the NDA process, a manufacturer would typically
seek to market its OTC product, either as a new NDA or as a switch from a prescription product.
● Under the ​OTC Drug Monograph Process​, the FDA reviews the active ingredients and the
labeling of over 80 therapeutic classes of drugs (e.g., antidiarrheals, analgesics, antacids) instead
of individual drug products. For each category, an OTC drug monograph is developed and
published in the Federal Register. OTC drug monographs can be likened to a recipe, whereby the
manufacturer adheres to the acceptable ingredients, doses, formulations, and labeling in the
 OTC monograph. The monographs define the safety, effectiveness, and labeling of all marketing
OTC active ingredients.
● Interestingly, pre-approval by FDA for drugs marketed under a drug monograph is not required
(i.e., you simply follow the “recipe”). On the other hand, if a drug cannot comply with the drug
monograph, an Investigational New Drug Application and approved NDA is necessary before the
drug product may be marketed. It would be advisable to check out an actual monograph to get a
better appreciation of how they work.
● See 21 CFR Part 331 for a discussion of the OTC monograph for antacids.

A DEA registration would terminate upon:

● A DEA registration terminates if and when the registration holder dies, ceases legal existence,
discontinues business or professional practice, or surrenders a registration. ​Any registrant who
ceases legal existence or discontinues business or professional practice shall notify the
administrator promptly of such fact. In the case of a registrant surrendering a registration, that
is accomplished by executing a DEA Form 104 or any signed writing indicating the desire to
surrender a registration.
● No registration can be assigned or otherwise transferred except upon specific conditions
imposed by the DEA and then only pursuant to written consent. Any person seeking authority to
transfer a registration shall submit a written request providing full details regarding the
proposed transfer of registration to the DEA.

Examples of adulteration?

The concept of adulteration should be fairly intuitive. When conjuring up an example of an adulterated
product, most individuals think of something that is contaminated, altered, or in some way different
from what it should be. However, there are a couple things worth noting in the context of adulteration.

The first is that a product is considered adulterated if it may have been contaminated​, which has
significant implications. For example, if the FDA inspects a manufacturing plant and notices dirty
conditions, it doesn’t have to prove that the products manufactured there are adulterated, simply that
they may be adulterated. ​The same concept applies to your dropping tablets on the floor and putting
them back in the vial​. The other issue to be aware of is the possibility that a product may be both
adulterated and misbranded. A product is misbranded if the label is false or misleading in any way.
When you read the fairly intuitive examples of adulteration below from the Food Drug and Cosmetic
Act, you will see that some of the examples of adulteration would clearly be misbranding also, because
the label would be false. A summarized list of drug adulteration examples from the Food Drug and
Cosmetic Act is listed below.

The act prohibits the interstate commerce of drugs and devices with impurities, poisons, and
decomposed ingredients. The statute also recognizes that while the drug itself may be pure, it still may
be considered adulterated within the meaning of the statute if:
 ● It is prepared, packed, or held under unsanitary conditions where it may have been
contaminated with filth or rendered injurious to health
● It is manufactured in a way that does not conform to Good Manufacturing Practice standards
established by the FDA
● The container is composed of a poisonous or deleterious substance that may leach into the
contents.
● It contains or is an unsafe color additive
● If it purports to be or is a drug that is recognized in an official compendium, and its strength,
quality, or purity varies from official compendial standards (unless its variations are plainly
stated on the label)
● If the drug is not listed in an official compendium, yet the strength, quality, or purity differs from
that which it purports to possess
● If it is a drug and any substance has been added to it to reduce its quality or strength, or any
substance has been substituted in whole or part
1. Section 351 Food Drug and Cosmetic Act Adulterated Drugs and Devices.
2. NMAC 16.19.8.7.

Applicable to a manufacturer of an OTC product that requires child-resistant packaging

● To make household substances that are subject to requirements for special packaging (i.e.,
child-resistant) readily available to elderly or handicapped persons who are unable to use those
substances in special packaging, section 4(a) of the Poison Prevention Packaging Act (PPPA)
authorizes manufacturers and packers to package such substances in noncomplying packaging
of a single size, provided that complying packaging is also supplied, and the noncomplying
packages are conspicuously labeled to indicate that they should not be used in households
where young children are present​.
● “This Package for Households Without Young Children” shall appear conspicuously on the
package of any household substance subject to the special packaging requirements of the PPPA
that is supplied in noncomplying packaging. If the area of the principal display panel is too small
to accommodate the statement required, the substitute statement “Package Not
Child-Resistant” may be used.
1. 16 CFR §1700.5 Noncomplying package requirements.

Required on the label when a nutritional support statement is made for a dietary supplement?

● Although the FDA does not directly regulate the approval of dietary supplements, they do
control the warning statements required on the label. ​The label requirements clearly point out
the purchaser that the product has not been evaluated by the FDA and that the product is not
intended to diagnose, treat, cure, or prevent any disease​. Always be on the lookout for test
questions that are seeing if you can identify when a dietary supplement manufacturer is pushing
the envelope in terms of the nutritional support claims on the label (i.e., promoting the product
more as a drug than a dietary supplement).
 ● See 21 CFR §101.36 Nutrition labeling of dietary supplements for a complete discussion of
labeling requirements for dietary supplements.
1. 21 CFR §101.36.

Assuming that a telepharmacy fills on average 100 prescriptions per day, how often does the
pharmacist from the hub pharmacy need to physically visit the telepharmacy?

● NM allows the use of telepharmacy to combat a shortage of pharmacies and pharmacists.

Operationally, a "Hub pharmacy" operating under the direct control of a pharmacist supervises a
remote telepharmacy, which is staffed by technicians. The "Hub pharmacist" oversees the
day-to-day operations of the remote telepharmacy via an electronic link that allows visual
observations and inspection of the inside of the pharmacy and all prescription orders prior to
dispensing. The link also allows the pharmacist to engage in patient consultation with patients at
the telepharmacy.
● The pharmacist employed by the hub pharmacy visits and completes inspections of the remote
telepharmacy according to a schedule that is based on the average number of prescriptions
filled per day (ANPFD). Listed below is the requisite number of visits based on the ANPFD.
● The pharmacist must physically visit the telepharmacy at least once a month when the ANPFD is
1 to 50; at least once ​every 2 weeks​ when the ANPFD is 51 to 100 per day; at least once per
week when the ANPFD is 101 to 150; and at least twice per week when the ANPFD is 151 to 200.
A pharmacist is required on site full-time during normal operating hours if the ANPFD exceeds
200.
● A quick read of the regulations listed below should adequately prepare you for any question that
might be asked related to telepharmacy.
1. NMAC 16.19.33.

Applicable to remote drug utilization review in this jurisdiction

● NM allows NM licensed pharmacies to conduct drug utilization reviews in remote practice

sites (including homes) by pharmacists who are licensed in NM and operating under the
direction of the pharmacist-in-charge (PIC).​ Pharmacists performing the DUR do not do any
dispensing, nor do they have any drugs at their respective remote sites. However, they are
subject to inspection by the board.
● The pharmacist-in-charge provides a written policy and procedure document to each practice
site outlining the operation and security of each remote pharmacist DUR location and keeps an
updated list of all remote sites (i.e., the address, phone number and hours of operation for each
site); The PIC is also responsible for ensuring that the NM pharmacy has a written agreement
with each remote pharmacist that outlines the conditions and policies governing the operation
of the remote site and for ensuring that security requirements are met.
● If the remote DUR site is located within a home, there must be a designated area in which all of
the pharmacist's work will be performed. The computer connection needs to be secure,
reserved solely for DUR, and no patient data can be stored at the remote site or transferred.
 ● The computer equipment must be locked or shut down whenever the pharmacist is absent,
must ensure patient confidentiality, and (if in a home) patient information can only be viewed
by the pharmacist.
1. NMAC 16.19.6.26.

Applicable to the transfer of controlled substance prescriptions?

● The rules for transferring prescriptions in New Mexico are pretty straightforward. The
prescription shall indicate that it has been transferred, and it must include the pharmacy
location and file number of the original prescription. The prescription shall show the date of
original fillings, as well as the number of valid refills remaining, in addition to the information
that would typically be included on a prescription. New Mexico also prohibits a pharmacy from
refusing to transfer a prescription when another pharmacy calls on behalf of a patient to request
a transfer.
● The transfer of Schedule III, IV, or V prescriptions is permitted on a one-time basis only unless
the pharmacies electronically share a real-time, online database, in which case they may
transfer up to the maximum refills permitted by law and the prescriber's authorization​. In
addition, the transfer must be communicated directly between 2 licensed pharmacists. The
transferring pharmacist writes the word “VOID​” on the face of the invalidated prescription; for
electronic prescriptions, information that the prescription has been transferred must be added
to the prescription record. The transferring pharmacist also records on the reverse of the
invalidated prescription the name, address, and DEA registration number of the pharmacy to
which it was transferred, the name of the pharmacist receiving the prescription information, and
their name as the pharmacist transferring the information. Electronic prescriptions are also
allowed to be transferred.
● The pharmacist receiving the transferred prescription information must write the word
“transfer”​ on the face of the transferred prescription and also include:
○ date of issuance of original prescription
○ original number of refills authorized on original prescription
○ date of original dispensing
○ number of valid refills remaining and date(s) and locations of previous refill(s)
○ pharmacy's name, address, DEA registration number, and prescription number from
which the prescription information was transferred
○ name of pharmacist who transferred the prescription
○ the pharmacy's name, address, DEA registration number, and prescription number from
which the prescription was originally filled
● Finally, although the DEA requires that the original and transferred prescription(s) must be
maintained for a period of 2 years from the date of the last refill, New Mexico has a general
requirement that original paper prescription documents must be maintained for a minimum
of 3 years and electronic prescriptions be maintained for 10 years.
1. NMAC 16.19.6.23.
2. 21 CFR §1306.25.
 3. NMAC 16.19.6.22.

The main pharmacy of a hospital routinely purchases prescription medications that may be resold to
which of the following?

● The Prescription Drug Marketing Act of 1987 (PDMA) addressed 3 primary weaknesses in the
drug distribution system that unnecessarily exposed the American public to unacceptable risk
from counterfeit, adulterated, misbranded, sub-potent, and expired drugs. ​The 3 areas dealt
with the reimportation of drugs into the US; the sample distribution system of manufacturers;
and the resale of drugs that are typically purchased by hospitals and other charitable
institutions at a reduced price.
● The above question deals with the resale issue of drugs purchased by hospitals, etc. The PDMA
handled this issue very directly in stating that no person may sell, purchase, or trade, or offer to
sell, purchase, or trade any prescription drug that was purchased by a public or private hospital
or other healthcare entity or was donated or supplied at a reduced price to a charitable
organization. However, there are a few reasonable exclusions that are built into the law as well.
For example, hospitals that are part of a group purchasing organization or under common
control can sell and trade with each other. Similarly, a charitable organization can sell/trade to a
nonprofit affiliate of the organization.
● There is also an exclusion that permits the sale of this class of drugs for emergency medical
reasons. This means that hospitals can sell drugs to a pharmacy if the pharmacy is experiencing a
temporary emergency shortage of a drug. Hospitals are also allowed to use the drugs that they
have purchased for prescriptions dispensed in any of its outpatient pharmacies but not any
retail pharmacies under its control. That would be unfair competition to the local retail
pharmacies.
● The PDMA also required the licensing of drug wholesalers, which is typically handled under the
laws of the individual state where the wholesaler is operating.
1. 21 CFR Part 203.
2. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/Pr
escriptionDrugMarketingActof1987/ucm201702.htm.

Assume that you own and operate a pharmacy and that you have a small amount of controlled
substances that were out of date and that could not be returned for credit. You would like to dispose
of them. What options are available to you?

● Since the DEA regulations that established rules for ultimate users to be able to return
unwanted/unused drugs to a pharmacy, there is a lot of confusion related to the disposal of
controlled substances. Probably the easiest way to understand the rules is to separately
consider the rules for ultimate users who wish to dispose of CS and the rules for the everyday
practice of pharmacy in which pharmacies have the occasional need to dispose of CS (e.g.,
outdated, damaged), etc​. In order to accept CS from an ultimate user for disposal, pharmacies
 have to modify their DEA numbers to become collectors.​ In addition, they ​must have an on-site
method of destruction that renders the drugs non-retrievable​.
● Contrast that situation with the day-to-day operation of a pharmacy that is not registered as a
collector. In that situation, a pharmacy has several choices. The pharmacy can promptly deliver
the CS to a reverse distributor by common or contract carrier pickup or by the reverse
distributor picking up the CS at the registrant's registered location. Alternatively, the pharmacy
can request assistance from the DEA by submitting 1 copy of the DEA Form 41, which lists the
controlled substance or substances that the registrant desires to dispose of.
● The DEA will instruct the registrant to dispose of the CS in one of the following ways:
○ by transfer to a registrant authorized to transport or destroy the substance
○ by delivery to an agent of the Administration or to the nearest office of the
Administration
○ by destruction in the presence of an agent of the Administration or another authorized
person
● Keep in mind that if a pharmacy uses the services of a reverse distributor, it is the subsequent
responsibility of the reverse distributor, not the pharmacy, to complete the DEA Form 41 that
gets sent to the DEA. When the pharmacy originally forwards the unwanted CS to the reverse
distributor, that transfer is accomplished pursuant to an invoice for Schedules III through V, or
per a DEA Form 222 for a Schedule II. Finally, if a pharmacy is registered as a collector, it may
destroy CS from its own stock (i.e., not just from an ultimate user). Of course, the pharmacy
would also have to keep accurate records of the destruction on a DEA Form 41, including the
signatures of 2 individuals who witnessed the destruction.
1. 21 CFR §1317.05.

Applicable to a pharmacist seeking to reciprocate their license to this jurisdiction?

● Reciprocal licensure shall be granted to those persons licensed by examination as a licensed

pharmacist in other jurisdictions that grant reciprocal privileges in New Mexico. An applicant
must be a graduate of an approved college of pharmacy and must have completed required
intern training or have worked 1 year as a licensed pharmacist in the state in which the applicant
has licensure by examination. An applicant shall be deemed to be ineligible to reciprocate if
licensure in the state of examination is not current, if the pharmacist has worked less than 1
year, or internship requirements at the time of examination did not meet New Mexico's
internship requirements.
● An applicant who has ​not been active in pharmacy for a period of 1 year or more​ shall be
required to ​complete such internship ​as the board shall deem necessary, but the internship
period shall be a ​minimum of 60 hours for each year the applicant has been inactive​.
● If an applicant has not been active in the area of pharmacy practice for greater than 1 year, but
less than 5 years, the pharmacist candidate has 2 options.
● The first would be to get their licensure current by
○ submitting a renewal form
○ paying past renewal fees and reinstatement fees
○ submitting proof of continuing education for each inactive renewal period
 ○ submitting proof of completed internship for each year of inactivity
○ successfully completing the MPJE
○ submitting a current letter of good standing from the state of examination
● The alternate option would be to simply complete the internship for each year of inactivity and
successfully pass the NAPLEX and the MPJE. Similarly, if a pharmacist has not been active in the
area of pharmacy practice for 6 years or more, the pharmacist candidate needs to complete the
internship for each year of inactivity and successfully pass the NAPLEX and the MPJE.
● A candidate shall take the MPJE no more than 5 consecutive times without passing.
1. NMAC 16.19.3.

Applicable to the disposal of controlled substances collected by a pharmacy from an ultimate user?

● On September 8, 2014, the Drug Enforcement Administration published the Final Rule for the
Disposal of Controlled Substances, which implements the Secure and Responsible Drug Disposal
Act of 2010. The rule became effective on October 9, 2014. Prior to the passage of the Act, there
were no legal provisions for patients to dispose of unwanted pharmaceutical controlled
substances except to give them to law enforcement; pharmacies, doctors’ offices, and hospitals
were not allowed to accept them.
● The final rule sets requirements for DEA registrants (including pharmacies) that voluntarily
decide to establish disposal programs to collect unwanted controlled substances from
ultimate users.​ The rule allows numerous DEA registrants to become authorized to establish
disposal programs, including manufacturers, distributors, reverse distributors, narcotic
treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies. These
registrants may become authorized to have disposal programs by modifying their DEA
registrations.
● The final rule allows a number of disposal program options including mail-back programs,
collection receptacles (which pharmacies can participate in), and collection events (which are
authorized only for law enforcement), ​although any person or pharmacy may partner with law
enforcement to hold a collection take-back event. Authorized hospitals/clinics and retail
pharmacies may maintain collection receptacles at long-term care facilities. In addition,
long-term care facilities may dispose of controlled substances on behalf of an ultimate user
residing or previously residing at the facility in the collection receptacle maintained by the
hospital/clinic or retail pharmacy.
● The rule requires destruction of collected controlled substances. It does not require a specific
method but does require that the destroyed substances be rendered non-retrievable (i.e.,
unavailable, unusable, and not capable of being transformed into a controlled substance). It also
sets specific requirements for process and records for the destruction of collected controlled
substances.
● The regulations are very detailed regarding these processes and should be read in their entirety
for a complete understanding, especially if a pharmacy is considering becoming a collector.
1. 21 CFR §1317.
Applicable to pharmaceutical services in a long-term care facility

● Listed below is not an exhaustive list, but it is a list of some of the more important requirements
related to pharmaceutical services in a long-term care facility.
● Each long-term care facility (LTCF) shall retain a ​consultant pharmacist​ who shall visit the facility
at least ​monthly ​to ​review the drug regimen of each resident​ and medication practices. The
pharmacist shall submit a written report of findings at least monthly to the facility's
administrator. This is not only required in the NM regulations but also by the Medicare
Conditions of Participation. What this means is that in order for an LTCF to receive federal
funding, it has to abide by this requirement.
● An LTCF may have 1 or more emergency medication kits available to each charge nurse. ​All
emergency kits shall be under the control of a pharmacist​. The emergency kit shall be sealed
and stored in a locked area. The facility shall have a policy and procedures for access by staff to
the emergency kit in case of need.
● For Schedule II drugs being administered in an LTCF, a proof-of-use record shall be maintained,
which lists—on separate proof-of-use sheets for each type and strength of Schedule II drug—the
date and time administered, resident's name, physician's name, dose, signature of the person
administering the dose, and balance. ​Proof-of-use records shall be audited daily​ by the
registered nurse or licensed practical nurse. So in essence, this is really a requirement for an
LTCF to have a perpetual inventory for all Schedule II substances.
● Unless otherwise ordered by a physician, a resident's medication not returned to the pharmacy
for credit shall be removed to a locked storage area when discontinued by a physician's order
and shall be destroyed within 30 days of the discontinuance. ​Records shall be kept of all
medication returned for credit and/or disposal​. Any controlled substances remaining after the
discontinuance of physician's orders or the discharge or death of the resident shall be
inventoried, and 1 copy shall be kept on file in the facility.
1. NMAC 7.9.2.57.

Generic substitution

● Upon receipt of a prescription written by a licensed practitioner for a multisource drug product
in the Orange Book, a pharmacist may dispense any of the listed therapeutically equivalent
drugs that are also lower in cost than the drug listed in the prescription. Drug product selection
shall be permitted unless the licensed practitioner prescribing prohibits drug product selection.
A licensed practitioner shall prohibit drug product selection by writing the words "no
substitution" or "no sub" on the face of a prescription. ​If a therapeutically equivalent drug
which is lower in price is selected, the pharmacist shall indicate on the label of the dispensed
container the brand of drug prescribed and the name of the drug dispensed. A pharmacist may
not select a therapeutically equivalent drug unless the pharmacist ​passes on to the patient all
savings between the net cost of the product prescribed and the product dispensed.
1. NM Stat. 26-3-3.
Over the course of the last 12 months, your pharmacy has dispensed 20,000 doses of controlled
substances pursuant to prescriptions. In that same 12-month period, your pharmacy has "distributed"
2,000 doses of controlled substances to other physicians in the area.

● The following activities require a separate DEA registration:

○ manufacturing
○ distributing
○ reverse distributing
○ dispensing
○ research of Schedule I substances
○ research of Schedule II-V substances
○ narcotic treatment program
○ importing
○ exporting
● Therefore, pharmacies would routinely register as dispensers. In addition, if the total number of
dosage units of all controlled substances distributed by the pharmacy during each calendar year
in which the pharmacy is registered to dispense exceeds 5% of the total number of dosage units
of all controlled substances distributed and dispensed by the pharmacy during the same
calendar year, the pharmacy will be required to register as a distributor.
● 2000/22000 = approximately 9%, requiring registration as a distributor.
● Otherwise, when a pharmacy is selling controlled substances to other healthcare practitioners in
more modest quantities, this would be considered a “coincidental activity,” for which no
additional registration would be required. When a pharmacy sells controlled substances to
another pharmacy or other healthcare practitioner, that would be considered a distribution
activity subject to the above formula.
● Any time a Schedule II substance changes hands, a DEA Form 222 is always completed. When a
Schedule III through V is sold to another practitioner, a simple invoice would suffice to capture
the transaction. Another underlying fundamental rule to remember is that a practitioner can
never write a prescription to obtain controlled substances for office stock from a pharmacy. The
transaction would have to be via an invoice or a DEA Form 222 as described above.
● 21 CFR §1307.11; also, see 21 CFR § 1301.13 for a list of those required to register with the DEA
in addition to a list of permitted coincidental activities. See also Section XIII of the Pharmacist’s
Manual for an explanation of the “5% rule.”
1. 21 CFR §1307.11.
2. 21 CFR §1301.13.

You receive a telephone prescription from a known physician for Tylenol #3 for a regular patient for a
quantity of 50, with directions of 1 tablet 3 times daily prn, with 3 refills. The patient has not been on
this medication previously.

● A pharmacist may dispense a controlled substance listed in Schedule III or IV only pursuant to:
○ a written prescription signed by a practitioner
 ○ a facsimile of a written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy
○ an oral prescription made by an individual practitioner
● It should be promptly reduced to written form by the pharmacist, containing all information
required for a prescription except the signature of the practitioner. ​A telephone order for a new
therapy for an opiate listed in Schedule III, IV, or V shall not exceed a 10-day supply​, based on
the directions for use ​unless a written prescription is on file at this pharmacy from any
practitioner for the same opiate within the past 6 months.​ ​A telephone order for this new
opiate therapy may not be refilled.
● Keep in mind that this is a more stringent requirement than the DEA regulations, which would
permit a telephoned prescription for a Schedule III with up to 5 refills without regard to whether
it was a new opiate or not.
1. NMAC 16.19.20.42.

Circumstances would require that a pharmacist obtain and review a PMP report before dispensing an
opioid prescription to a patient

● A pharmacist shall use professional judgment in determining whether to obtain and review a
PMP report before dispensing an opioid prescription to a patient, and the pharmacist shall
document their action regarding such reports. ​A pharmacist shall request and review a PMP
report covering at least a 1-year time period ​and another states’ report in the following
situations:
○ Exhibiting potential abuse or misuse of opioids (e.g., over-utilization, early refills,
multiple prescribers, appears overly sedated or intoxicated, etc.)
○ Paying cash when the patient has prescription insurance
○ Unfamiliar prescriber outside the area writing an opioid prescription or for an unfamiliar
patient who resides outside the area
○ Initial prescription for any long-acting opioids
○ Opioid concurrently with a benzodiazepine or carisoprodol
● Upon recognizing any of the above scenarios, a pharmacist, using professional judgment, shall
take appropriate steps to avoid or resolve the potential problem (except for an opioid
prescription written for LTCF patient or for a patient with a medical diagnosis documenting a
terminal illness; these are exempt). These steps may include consulting with the prescriber and
counseling the patient. The pharmacist shall document steps taken to resolve the potential
problem.
● PMP reports shall be reviewed a minimum of once every 3 months during the continuous use
of opioids​ for each established patient. The pharmacist shall document the review of these
reports.
1. NMAC 16.19.4.16.
Information is/are required to be submitted by the pharmacist to the Prescription Monitoring
Program (PMP) for all controlled substance prescriptions dispensed

● As part of the NM Prescription Monitoring Program (PMP), pharmacies are ​required to submit
the following information on all Schedule II through Schedule V controlled substance
prescriptions at least within 1 business day of the prescription being filled​:
○ Dispenser NPI number
○ Dispenser NCPDP number
○ Dispenser DEA number
○ Patient name, patient address, patient date of birth, patient gender
○ Reporting status (new, revised, void)
○ Prescription number
○ Date prescription was written
○ Refills authorized
○ Date prescription filled
○ Refill number
○ Product ID (NDC) + product ID qualifier
○ Quantity dispensed; days’ supply
○ Drug dosage units
○ Transmission form of Rx origin
○ Payment type
○ Prescriber NPI number
○ Prescriber DEA number
● It should not be difficult identifying any of these required data points on an exam. If you think
about it, you really need to submit virtually any relevant piece of information for any controlled
substance prescription.
1. NMAC 16.19.29.8.

Requirements apply in order for an intern or resident to use the hospital DEA number in lieu of
obtaining their own

● Interns or residents who are not individually registered with the DEA are required to use the
DEA number of the institution and the code number assigned by the institution for such
purpose​. Any practitioner who is an intern, resident, or foreign physician may dispense and
prescribe controlled substances under the registration of the hospital or other institution that is
registered and by whom the physician is employed, provided that
○ the dispensing or prescribing is in the usual course of professional practice
○ the practitioner is authorized or permitted to do so by the laws of the state
○ the hospital or institution has determined that the practitioner is permitted to dispense
or prescribe drugs in the state
○ the practitioner acts only within the scope of employment in the hospital or institution
 ○ the hospital or institution authorizes the intern, resident, or foreign physician to
dispense or prescribe under its registration number and assigns a specific code number
for each practitioner so authorized
● Typically, the assigned code is either numbers or letters or a combination of both that is
attached as a suffix to the institution’s DEA number.
● NM has an additional requirement​ that the hospital or clinic needs to submit a current list of
authorized practitioners with each controlled substance renewal application. NM also includes
staff physicians and mid-level practitioners under this waiver.
1. 21 CFR §1301.22.
2. NMAC 16.19.20.8.

Training requirements for compounding sterile preparations

● All personnel​, including pharmacists, pharmacists who supervise compounding personnel,

pharmacist interns, and pharmacy technicians, shall have completed ​didactic and experiential
training​ ​with competency evaluation through demonstration and testing (written or practical)
as required by USP/NF <797> (Pharmaceutical Compounding-Sterile Preparations). Experiential
training shall include glove fingertip and media-fill tests. Glove fingertip testing simply involves
checking the gloves for contamination, and media-fill tests assess whether someone is practicing
aseptic technique and where growth media is substituted for the drug.
● Instructional topics shall include:
○ aseptic technique
○ critical area contamination factors
○ environmental monitoring; facilities
○ equipment and supplies
○ sterile pharmaceutical calculations and terminology
○ sterile pharmaceutical compounding documentation
○ quality assurance procedures
○ proper gowning and gloving technique
○ the handling of cytotoxic and hazardous drugs
○ general conduct in the controlled area
● Pharmacy technicians shall complete 100 hours of documented experiential training​ in
compounded sterile preparations.
● All personnel ​compounding sterile hazardous drugs​ ​shall have completed​ ​didactic and
experiential training​ with competency evaluation through demonstration and written or
practical testing ​in addition to training in sterile non-hazardous preparations​.
● Training for sterile compounding and compounding of sterile hazardous drugs will be conducted
as outlined by the pharmacist-in-charge and described in the policy and procedures or training
manual and shall be completed prior to compounding applicable preparations.
● Training shall include:
○ initial training before compounding sterile preparations
○ annual refresher​ training and assessment in didactic topics
 ○ annual testing of glove fingertip and media fill for low and medium risk compounding
○ 6-month testing of glove fingertip and media fill testing for high-risk compounding
● Written documentation​ ​of all training and process validation of compounding personnel shall
be​ ​retained for 3 years​ and, in addition to the administrative details, shall also contain the
signature of the person receiving the training or completing the testing or process validation and
the pharmacist-in-charge or other pharmacist designated as responsible for training, testing, or
process validation of personnel.
1. NMAC 16.19.36.13.

Emergency CII prescription

● In this scenario, the rules for NM are virtually identical to the federal rules. If an emergency
exists, a pharmacist may dispense a Schedule II substance upon receiving oral authorization (or
fax authorization) of a prescriber provided that the quantity prescribed and dispensed is limited
to the amount adequate to treat the patient during the emergency period, and the prescription
shall be immediately reduced to writing by the pharmacist and shall contain all information
required except for the signature of the prescribing individual practitioner. If the practitioner is
not known to the pharmacist, the pharmacist must make a reasonable effort to determine that
the oral authorization came from a registered individual practitioner.
● Within 7 days after authorizing an emergency oral prescription, the prescribing individual
practitioner shall cause a written prescription for the emergency quantity prescribed to be
delivered to the dispensing pharmacist.​ The prescription shall have written on its face
“Authorization for Emergency Dispensing,” and the date of the oral order. The paper
prescription may be delivered to the pharmacist in person or at least be postmarked within the
7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the
oral emergency prescription that had earlier been reduced to writing. For electronic
prescriptions, the pharmacist must annotate the record of the electronic prescription with the
original authorization and date of the oral order.
● The pharmacist must notify the nearest office of the DEA if the prescribing individual
practitioner fails to deliver a written prescription​; failure of the pharmacist to do so shall void
the authority to dispense without a written prescription of a prescribing individual practitioner.
The only difference between the above and NM law is that in NM the pharmacist needs to notify
the State Board of Pharmacy in addition to the DEA.
● One area that could be tested here is your knowledge of what constitutes an emergency,
namely that immediate administration of a controlled substance is necessary for proper
treatment: that no appropriate alternative treatment is available (e.g., CIII), and that it is not
reasonably possible for the prescribing practitioner to provide a written prescription to be
presented to the person dispensing the substance prior to the dispensing. Remember, if there is
not an emergency, there can be no emergency dispensing.
1. 21 CFR § 1306.11.
2. 21 CFR §290.10 (for definition of emergency).
3. NMAC 16.19.20.47.
You have been regularly partial filling Schedule II prescriptions for patients in the long-term care
facilities (LTCFs) that your pharmacy services. Today, you get a visit from a DEA inspector who wants
to review your records related to that dispensing. What will the DEA be looking for?

● The DEA will allow information related to partial fills for CII drugs for residents of LTCFs or
terminally ill patients to be maintained in a computerized system if this system has the
capability to permit:
● Output (display or printout) of the original prescription​ number, date of issue,
identification of prescribing individual practitioner, identification of patient, address of
the LTCF or address of the hospital or residence of the patient, identification of
medication authorized (to include dosage, form, strength, and quantity), and a listing of
the partial fillings that have been dispensed under each prescription
● Immediate (real time) updating of the prescription record each time a partial filling of
the prescription is conducted
● Online retrieval of partially filled Schedule II prescription information
1. 21 CFR §1306.13.

Mr. Brown comes into your pharmacy with a prescription for his wife for 50 Demerol 50 mg and
explains to you that she is terminally ill. He asks you to only give him a few tablets at a time since,
according to the doctor, his wife is not likely to be around for more than a week. What are applicable
in this situation?

● CII prescriptions written for LTCF patients or for a patient with a terminal illness may be filled
in partial quantities​. If there is any question, the ​pharmacist must verify that the patient has a
terminal illness​ and shall record on the Rx "terminally ill" or an "LTCF" patient. Both the
pharmacist and the prescribing practitioner have a corresponding responsibility to assure that
the controlled substance is for a terminally ill patient. A prescription that is partially filled and
does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been
filled in violation of the Controlled Substance Act and the NM regulations. For each partial filling,
record date of the partial filling, quantity dispensed, remaining quantity, and the ID of the
dispensing pharmacist.
1. 21 CFR §1306.13.
2. NMAC 16.19.20.46.

Mrs. Martin comes into your pharmacy with a prescription for Oxycontin 20 mg that was written for a
quantity of 100 tablets. However, you only have 75 tablets in stock. She pays for the 75 tablets now.
She says that she will pick up the balance later. What are applicable in this situation?

● The rules for partial filling of CII prescriptions in NM are virtually identical to the DEA
regulations. Partial filling of a CII prescription is permissible if the pharmacist is unable to supply
the full quantity and makes a notation of the quantity supplied on the face of the prescription.
 The remaining portion of the prescription may be filled within 72 hours of the partial filling;
however, if the remaining portion cannot be filled within 72 hours, the pharmacist shall so notify
the prescribing individual practitioner. No further quantity beyond 72 hours would be permitted
without a new Rx.
● There is a subtle difference between the DEA regulation and the NM regulation worth noting.
The DEA regulations state that ​if the remaining portion is not or cannot be filled within the
72-hour period, the pharmacist shall notify the prescribing individual practitioner​, whereas the
NM regulations state that the pharmacist shall notify the practitioner if the balance cannot be
filled. So, in the question scenario, the pharmacist would have to notify the practitioner if the
patient decided that she simply did not want the balance (even if the pharmacy had it in stock
within 72 hours) since that is the more stringent regulation.
1. NMAC 16.19.20.46.
2. 21 CFR §1306.13.

Refills for controlled substance prescriptions

● This is another situation where NM law closely follows federal law. Both follow the general rule
that a CIII through CV prescription cannot be refilled more than 5 times or filled beyond a
6-month time period. After the 5 refills or 6 months have occurred, the prescriber must write a
new prescription/order and cannot add any additional refills beyond 5 original refills.
● There are 2 additional refill limitations in NM law that are worth noting. The first is that CS
prescriptions dispensed directly to a patient shall ​not be refilled before 75% of the prescription
days' supply has passed​ unless the practitioner authorizes the early refill, which must be
documented by the pharmacist. The second is that for CS prescriptions delivered to a patient
indirectly (e.g., ​mail order​) shall ​not be refilled before 66% of a 90-day supply ​has passed ​or
50% of a 30-day supply has passed​ unless the practitioner authorizes the early refill, which must
be documented by the pharmacist.
● Although NM is silent on this, it is worth noting that the DEA regulations specify that the
prescribing practitioner may authorize additional refills of Schedule III or IV controlled
substances on the original prescription through an oral refill authorization transmitted to the
pharmacist provided the following conditions are met:
● the total quantity authorized, including the amount of the original prescription, does not
exceed 5 refills nor extend beyond ​6 months​ from the date of issue of the original
prescription
● the quantity of each additional refill authorized is equal to or less than the quantity
authorized for the initial filling of the original prescription
1. NMAC16.19.20.45.
2. 21 CFR §1306.22.
What are the situations would a faxed prescription from the physician's office to a retail pharmacy be
allowed to serve as the original (i.e., no need to get an original hard copy of the prescription before
dispensing)?

● A prescription for a Schedule II controlled substance may be transmitted by the practitioner or

the practitioner's agent to a pharmacy via facsimile equipment provided the original written,
signed prescription is presented to the pharmacist for review prior to the actual dispensing of
the controlled substance​. However, under federal law (which is similar to NM law), there are 3
exceptions in which the fax can serve as the original:
○ a Schedule II narcotic to be compounded for direct administration to a patient by
parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion
○ a Schedule II narcotic for a hospice patient
○ any Schedule II substance for a patient in a long-term care facility
● In the above scenario for hospice patients, the practitioner or the practitioner's agent will note
on the prescription that the patient is a hospice patient.
● Faxes for CIII-CV can serve as the original also.

References

1. NMAC16.19.20.42.
2. 21 CFR §1306.11.
3. 21 CFR §1306.21.

What are operational requirements for centralized prescription dispensing in this jurisdiction?

● New Mexico is not unlike many other states in requiring that pharmacies who outsource the
dispensing function to another pharmacy have either the ​same owner​ or have entered into
a​written contract or agreement ​and they must share a​ common electronic file or similar
technology​.
● A pharmacy that outsources prescription dispensing to another pharmacy is required to ​notify
patients​ that their prescription may be outsourced and to provide the name of the individual
pharmacy or network of pharmacies that may dispense the prescription (e.g., signage).
● If the prescription is delivered directly to the patient by the dispensing pharmacy upon request
by the patient and not returned to the requesting pharmacy, the pharmacist employed by the
dispensing pharmacy shall ensure that the patient receives written notice of available
counseling. For pharmacies delivering more than 50% of their prescriptions by mail or another
common carrier, the hours of availability shall be a minimum of 60 hours per week and not less
than 6 days per week. The facility must have sufficient toll-free phone lines and personnel to
provide counseling within 15 minutes.
 ● The dispensing pharmacy shall place on the prescription label the name and address or name
and pharmacy license number of the pharmacy dispensing the prescription and the name and
address of the pharmacy that receives the dispensed prescription. The dispensing pharmacy
shall indicate in some manner which pharmacy actually dispensed the prescription.
● A policy and procedure manual shall be maintained at both pharmacies and be approved by the
board or its agent and be available for inspection. Each pharmacy is required to maintain only
those portions of the manual that relate to that pharmacy's operations.
1. NMAC 16.19.6.25.

What are the required related to the issuance of a controlled substance prescription/order?

● NM closely follows federal law as it relates to the rules associated with the issuance of a
controlled substance prescription/drug order. A prescription for a controlled substance may be
issued for a ​legitimate medical purpose​ by an individual practitioner acting in the ​usual course
of professional practice​ and who is registered under the Controlled Substances Act. The
responsibility for the proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, but a ​corresponding responsibility rests with the pharmacist​ who fills
the prescription. An order purporting to be a prescription issued not in the usual course of
professional treatment or in legitimate and authorized research is not a legitimate prescription,
and the person knowingly filling such a purported prescription, as well as the person issuing it,
shall be subject to the penalties provided for violations of the provisions of law relating to
controlled substances.
● A good example would be if a dentist wrote a prescription for Tylenol #3 as a favor for a friend
with knee pain. When a dentist is writing for knee pain, it is not in the usual course of
professional practice. The pharmacist has a corresponding responsibility not to dispense the
prescription. Knowingly dispensing a prescription in this scenario would expose the pharmacist
to criminal penalties by the DEA and administrative penalties imposed by the Board of
Pharmacy. See Section IX of the Pharmacists Manual for a further discussion of corresponding
responsibility, available at
https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html.
● Another fundamental principle is that ​a prescription may not be issued in order for a
practitioner to obtain controlled substances for supplying the practitioner for the purpose of
general dispensing to patients​. This does not mean that a physician cannot obtain controlled
substances from a pharmacy, but only that it would be by means of an invoice or a DEA Form
222 in the case of a Schedule II drug.
● A controlled substance prescription may not be issued for the dispensing of narcotic drugs listed
in any schedule to a narcotic-dependent person for the sole purpose of continuing their
dependence upon such drugs. Remember, however, that there is an exception for drugs such as
Buprenorphine or Buprenorphine in combination with Naloxone. Physicians can write
prescriptions for these drugs for opiate addicts. They can be filled in a retail pharmacy.
1. 21 CFR §1306.04.
2. NMAC 16.19.20.41.
 3. 21 CFR §1301.28.

Assuming that they have the proper training and registrations, which nurses can prescribe controlled
substances in this jurisdiction?

● The following nurses have prescriptive authority in NM:

○ Certified Nurse Practitioner
○ Clinical Nurse Specialist
○ Certified Nurse Midwife
○ Certified Registered Nurse Anesthetist
● Each of the above nurses needs to complete the requisite training mandated by the Board of
Nursing​. Additionally, should they wish to prescribe controlled substances in Schedules II
through V, they need to register with the DEA and the State Board of Pharmacy. However, ​a
Certified Nurse Midwife is not allowed to prescribe controlled substances.​ Regulatory citations
are provided below if you wish to obtain a more detailed looked at the prescriptive authority
regulations for each of the respective nursing classifications.

What are applicable to the prescriptive authority of a physician assistant in this jurisdiction?

● Physician assistants (PAs) may administer and prescribe formulary drugs; these include
Schedule II-V controlled substances under the direction of the supervising physician where
there is an established physician or physician assistant-patient relationship​. They may
telephone prescriptions to pharmacies for any drug they are authorized to prescribe. Keep in
mind that PAs authorized to prescribe controlled substances must register individually with the
DEA as well as the State Board of Pharmacy. The DEA registration is good for 3 years, while the
registration with the State Board of Pharmacy is an annual requirement.
● The PA's prescription pad needs to contain the name, business address, and telephone number
of the supervising physician; it must also contain the name, title, and the NM license number of
the PA.
● If the signature line is without MD, PA, or PA-C printed after it, the PA or PA-C must add the
designation "PA" or "PA-C" at the end of the signature line when signing a prescription; if the PA
or PA-C must use a prescription pre-printed with "MD" at the end of the line, the designation
"MD" must be clearly crossed out, and "PA" or "PA-C" must be added.
● Note that when a PA writes a prescription, in all cases the signature of the PA is required, not
that of the supervising physician. The name of the PA should also be placed on the prescription
label as the prescriber.
1. NMAC 16.10.16.8.
2. NMAC 16.19.20.10.
3. 21 CFR §1301.13.
While you were up on the hospital floor, one of the nurses asked you what happens if the pharmacy is
closed and one of the patients needs an emergency medication. What are applicable to after-hours
access?

● A record of the removal is required to include:

○ name of patient
○ name of drug, strength, and dosage form
○ dose prescribed
○ quantity taken
○ time and date
○ signature or electronic signature of the person making the withdrawal
● The original or direct copy of the medication order may substitute for such record.
● The nurse withdrawing the drug shall include with the record an example of what was
removed​. The pharmacist shall verify the withdrawal within 72 hours.
● A drug regimen review will be conducted by a pharmacist either on-site or by electronic
transmission within 24 hours for any new drug order.
● Another duly registered pharmacy may supply medications pursuant to a patient-specific
medication order provided if the supplying pharmacy and pharmacist are licensed in the state.
1. NMAC 16.19.7.9.

What are requirements related to OBRA '90?

● OBRA ’90​ placed several requirements on pharmacists that are intended to improve patient
outcomes. Although the law originally applied to Medicaid patients, the requirements have been
incorporated into the standards of practice for all patients. The OBRA requirements include:
○ Counseling requirements​ (i.e., offer to counsel)
○ Prospective drug utilization review requirements​ (i.e., screening a patient’s history and
medications prior to dispensing a prescription)
○ Record-keeping requirements ​(i.e., patient profile)
● The drug utilization review ​includes screening for potential drug therapy problems​ due to
therapeutic duplication; also included are drug-drug interactions, including serious interactions
with over-the-counter drugs, incorrect drug dosage or duration of drug treatment, drug-allergy
interactions, and clinical abuse or misuse.
1. Omnibus Budget Reconciliation Act of 1990.

You have just graduated from pharmacy school and are excited about the expanded opportunities
potentially available to you as a pharmacist clinician (e.g., prescriptive authority). Which of the
following are applicable requirements for pharmacist clinicians in this jurisdiction?

● To obtain initial certification and registration a pharmacist clinician must submit proof of
completion of ​60-hour board approved physical assessment course​, followed by a ​150-hour,
300-patient contact preceptorship​ supervised by a physician or other practitioner with
 prescriptive authority. Patient encounters must be initiated and completed within 2 years of the
application.
● A pharmacist clinician requesting a controlled substance registration to prescribe controlled
substances in Schedule II or Schedule III shall be trained in responsible opioid prescribing
practices.
● On the biennial renewal of registration, the pharmacist clinician needs to submit proof of
completion of​ 20 contact hours of live CPE or continuing medical education (CME) beyond the
30 contact hours required ​for a traditional pharmacist renewing their license. A pharmacist
clinician with a controlled substance registration to prescribe controlled substances listed in
Schedule II or Schedule III also needs to complete a minimum of​ 2 contact hours per renewal
period​ in the subject area of responsible opioid prescribing practices. With the biennial renewal,
the pharmacist clinician also needs to submit a current ​protocol of collaborative practice​ signed
by the supervising physician and a copy of the pharmacist clinician's registration with the
supervising physician's board.
1. NMAC 16.19.4.17.

Assuming that a qualified physician has been treating patients for opioid dependence in an
office-based treatment program for more than 1 year, that physician can request to treat up to how
many patients going forward?

● The initial threshold for the number of patients is 30. Once a qualified physician has practiced in
this arena for a year, they can apply to treat up to ​100 patients​. Regulations have recently been
enacted for qualified physicians to be able to request to treat up to 275 patients provided that
they meet certain qualifications and have treated up to 100 patients for a year.
1. http://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management.

Which are the requirements on counseling per OBRA '90

● A pharmacist or pharmacist intern shall personally offer to counsel​ patients for ​new
prescriptions/drug orders. ​Note that this is more stringent than the OBRA requirement that the
patient simply be given an offer to be counseled by someone employed by the pharmacy. For
refill prescriptions drug orders, a pharmacy technician can ask the patient or agent if they
would like to be counseled by the pharmacist or intern​. The counseling shall be in person,
whenever practicable, or by telephone. There is nothing specific that has to be discussed, as this
is left to the professional discretion of the pharmacist or intern. Examples of what may be
discussed include:
○ the name and description of the drug
○ the dosage form, dosage, route of administration, and duration of drug therapy
○ intended use of the drug and expected action
○ special directions and precautions for preparation, administration, and use by the
patient
 ○ common severe side or adverse effects or interactions and therapeutic
contraindications that may be encountered, including their avoidance and the action
required if they occur
○ techniques for self-monitoring drug therapy
○ proper storage
○ prescriptions refill information
○ action to be taken in the event of a missed dose
○ the need to check with the pharmacist or practitioner before taking other medication
○ pharmacist comments relevant to the individual's drug therapy, including any other
information peculiar to the specific patient or drug
○
● Patient counseling by pharmacists or interns​ ​shall not be required for inpatients of a hospital
or institution​ where other licensed health care professionals are authorized to administer the
drug(s).
● A pharmacist shall in no way attempt to circumvent or willfully discourage a patient or patient's
agent from receiving counseling. However, a ​pharmacist or intern shall not be required to
counsel a patient or patient's agent when the patient or patient's agent refuses such
consultation​. When the patient or agent is not present when the prescription is dispensed (e.g.,
a prescription that was mailed), the pharmacist shall ensure that the patient receives written
notice of available counseling (i.e., days and hours of availability, their right to request
counseling, toll-free telephone number to obtain oral counseling). ​For pharmacies delivering
more than 50% of their prescriptions by mail or another common carrier, the hours of
availability shall be a minimum of 60 hours per week and not less than 6 days per week​. The
facility must have sufficient toll-free phone lines and personnel to provide counseling within 15
minutes.
● In ​every pharmacy​, there shall be a ​notice concerning available counseling prominently posted
and readable by prescription consumers​.
1. NMAC 16.19.4.16.

A patient comes into your pharmacy to pick up a controlled substance prescription and you ask for
identification. The patient complains that they had to show ID last month and asks if ID will be
required every time. Which of the following is/are applicable exceptions from having to show
identification upon receiving a controlled substance prescription?

● A pharmacy employee ​shall verify the identity of the patient or the patient's
representativewho is receiving any prescription for a controlled substance​ listed in Schedule II,
III, IV, or V before it is released. Acceptable identification means a current state issued driver's
license (including a photo) or other current government issued photo identification of the
person presenting said identification. The ​identification type​ (e.g., driver's license, identification
card, passport), ​number, name imprinted on that identification, and state must be recorded​.

Exceptions are:
 ● a new controlled substance prescription filled for a patient known to the pharmacist or
pharmacist intern whose identification has already been documented in a manner determined
by a written policy developed by the pharmacist-in-charge
● a ​controlled substance prescription filled for home delivery​;
● a ​controlled substance prescription filled for and delivered to a licensed facility
1. NMAC 16.19.20.42.

Examples of Schedule III controlled substances?

An independent pharmacy owner decided to retire and transfer total business operations, including
controlled substances, to a local chain pharmacy. How soon before the owner actually transfers the
business must the required information related to the transfer be submitted to the regional DEA
administrator either in person or by registered or certified mail (return receipt requested)?

● Any registrant desiring to discontinue business activities altogether or with respect to controlled
substances (by transferring such business) shall submit in person or by registered or certified
mail, return receipt requested, to the DEA, ​14 days​ in advance of the date of the proposed
transfer (unless waived), the following information:
○ the name, address, registration number, and authorized business activity of the
registrant discontinuing the business (registrant-transferor)
○ the name, address, registration number, and authorized business activity of the person
acquiring the business (registrant-transferee)
○ whether the business activities will be continued at the location registered by the
person discontinuing business or moved to another location (if the latter, the address of
the new location should be listed)
○ the date on which the transfer of controlled substances will occur
● Unless the registrant-transferor is informed by the DEA before the date on which the transfer
was stated to occur that the transfer may not occur, the registrant-transferor may distribute
controlled substances in their possession to the registrant-transferee in accordance with the
following:
● On the date of transfer of the controlled substances, a complete inventory of all
controlled substances being transferred shall be taken. This inventory shall serve as the
final inventory of the registrant-transferor and the initial inventory of the
registrant-transferee, and a copy of the inventory shall be included in the records of
each person.
● On the date of transfer of the controlled substances, all records required to be kept by
the registrant-transferor with reference to the controlled substances being transferred
shall be transferred to the registrant-transferee. Responsibility for the accuracy of
records prior to the date of transfer remains with the transferor, but responsibility for
custody and maintenance shall be upon the transferee.
 1. 21 CFR §1301.52.

If a patient finds a mistake on their printout of prescription drugs and requests that the pharmacy
amend the pharmacy records, the pharmacy must comply within how long?

● 60 days​ is the correct response.

● The right to amend one’s PHI records is one of the primary patient rights that are included in the
Notice of Privacy Practices. The other 2 primary rights are the right of access to one’s records
and the right to an accounting of disclosures of one’s personal health information, or PHI.
● An example of how the right to amend might come up in a pharmacy would be where a
pharmacy had 2 patients with the same name and some of the prescription activity was
inadvertently placed on the wrong patient profile. The actual HIPAA privacy regulations explore
additional situations, such as when a covered entity can deny a request to amend and also has
procedures on where a covered entity like a pharmacy may need to get involved in informing
others to any amendments to a patient’s records. They are explored in depth in 21 CFR §164.526
Amendment of Protected Health Information.
● It is worth nothing that it is unlikely for a pharmacy to encounter most of those scenarios.
1. 21 CFR §164.526.

What are the operational requirements for reverse distributors?

● Reverse distribution is the acquisition of controlled substances from another registrant, such as
a pharmacy or law enforcement agency, for the purpose of returning to the registered
manufacturer (or authorized representative) or for destruction. ​A reverse distributor is required
to register with the DEA.
● Operationally​, a pharmacy may forward controlled substances at any time to a DEA registered
reverse distributor​. When a pharmacy transfers Schedule II controlled substances to a reverse
distributor for destruction, ​the reverse distributor must submit a DEA Form 222​ or the
electronic equivalent to the pharmacy. When Schedules III-V controlled substances are
transferred to a reverse distributor for destruction, the pharmacy must maintain a record that
lists the drug name, dosage form, strength, quantity, and date transferred. The DEA-registered
reverse distributor who will destroy the controlled substances is responsible for submitting a
DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled
substances have been destroyed. A DEA Form 41 should not be used to record the transfer of
controlled substances between the pharmacy and the reverse distributor disposing of the drugs.
1. 21 CFR 1300.01.
2. DEA Pharmacists Manual. https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/.

What of the following are applicable to the impaired professional program?

 ● New Mexico has a program for impaired pharmacist and others licensed/registered by the
board that operates by either board referral or through voluntary participation​. The board has
appointed a committee to administer the program. In the case of board referrals, the board
refers licensees in lieu of or in addition to other disciplinary action. The board is ​not aware of
those licensees who avail themselves of the program voluntarily​ (unless, of course, they do not
comply with the rules of the program). This program is applicable to all licensed/registered
externs, interns, pharmacists, and any other board licensee/registrant.
● All participants in the program are informed of their respective responsibilities and
consequences for not adhering to the rules. Failure to comply with any treatment provision of a
program may result in termination of the participation in the program and being reported to the
board. The board is notified of any failure to comply that is deemed to pose a threat to the
health and safety of the public if the licensee were to resume practice.
● When an impaired licensee who has been reported to the board successfully completes a
board/committee-approved treatment program, that licensee must​ appear before the board​.
The licensee must provide documentary evidence from the approved treatment program,
stating that the licensee has reached recovery and may be allowed to practice without
endangering the public. The board may suspend the registration/license, stay the execution of
the suspension, and impose a period of probation during which the following conditions shall be
met:
● the licensee shall strictly adhere to the aftercare program
● during the probationary period, the licensee shall comply with the general and special
conditions of probation imposed by the board, including but not limited to, monitoring
and drug screens where applicable
● No member of the board or the committee or any board-approved intervenor shall be
liable for any civil damages​ because of acts or omissions which may occur while acting
in good faith pursuant to the Impaired Pharmacists Act.
1. NMS 61-11A.
2. NMAC 16.19.4.12: Impaired pharmacists.

When completing a 222 Order Form, (i.e., when a pharmacy is ordering from the wholesaler)

● The pharmacy submits copy 1 and copy 2 of the DEA Form 222 to the supplier and retains copy
3 in the pharmacy files​.
● The supplier must record on copies 1 and 2 the number of commercial or bulk containers
furnished on each item and the date on which the containers are shipped to the pharmacy. If an
order cannot be filled in its entirety, it may be filled in part and the balance supplied by
additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222
is valid more than 60 days after its execution by a pharmacy. The controlled substances must be
shipped only to the pharmacy and the location pre-printed on the DEA Form 222. The supplier
must retain copy 1 of the DEA Form 222 for his or her files and forward copy 2 to the DEA. Copy
2 must be forwarded at the close of the month during which the order is filled. If an order is
filled by partial shipments, copy 2 must be forwarded at the close of the month during which the
 final shipment is made or the 60-day validity period expires. The pharmacy must record on copy
3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and
the dates on which the containers are received by the purchaser.
1. 21 CFR §1305.13.

What are the applicable to optometrist prescriptive authority in this jurisdiction?

● Subject to the provisions of the Optometry Act, NM licensed optometrists may prescribe or
administer all pharmaceutical agents for the diagnosis and treatment of diseases of the eye or
adnexa,​ including controlled substances classified as Schedule II-V​. However, ​optometrists are
limited to prescribing only hydrocodone and hydrocodone-combination medications in
Schedule II​. They may also administer epinephrine auto-injections to counter anaphylaxis.
● Prior to an optometric physician administering, dispensing, or prescribing any controlled
substances, they must register with the State Board of Pharmacy in addition to the DEA.
● The licensee must display the pharmaceutical certificate(s) for which they have been qualified
and certified by the board in a conspicuous place at their principal office or place of business.
● All NM licensed optometrists shall have pharmaceutical certification as determined by the board
prior to licensure and may use the title "optometric physician." Previously, optometrists had the
option of obtaining additional training that would allow them different levels of prescriptive
authority.
1. NMAC 16.16.7.

Which are the exempt from having to procure a DEA registration in order to prescribe controlled
substances?

● The requirement of registration is waived for any official of the U.S. Army, Navy, Marine
Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons​ who is authorized to
prescribe, dispense, or administer, but not to purchase controlled substances in the course of
official duties. They state the branch of service or agency (e.g., “U.S. Army” or “Public Health
Service”) and the service identification number of the issuing official in lieu of the DEA
registration number required on prescription forms. If any official named above also engages as
a private individual in any activity for which registration is required, such official shall obtain a
registration for such private activities.
1. 21 CFR §1301.23.

What are the requirement of a wholesaler application for licensure?

● Every wholesale drug distributor who engages in wholesale distribution into, out of, or within
this state must be licensed by the board before engaging in wholesale distribution of
prescription drugs.
● The application to the board requires:
 ○ that the distributor supply ​all trade or business names ​used by the licensee
○ name(s) of the owner and operator​ of the licensee (if not the same person) including
specific detailed information about the principal owners in a partnership, corporation,
sole proprietorship, or limited liability company
○ the name(s), business address(es), telephone number(s) of a person(s) to serve as the
designated representative​(s) for each facility of the wholesale distributor
○ a list of all state and federal licenses, registrations, or permits, including any other state
and federal authority
○ a list of all disciplinary actions by state and federal agencies against the wholesale
distributor, principals, owners, directors, or officers
○ a ​full description of each facility and warehouse
○ a ​copy of the deed​ for the property ​or applicable lease
○ information regarding general and ​product liability insurance​, including copies of
relevant policies
○ a description of the wholesale distributor's ​drug import and export activities
○ a copy of the wholesale distributor's written ​policies and procedures
● NMAC 16.19.8.8.
● NMAC 16.19.8.9​.