Pharmacy Law Review 2020 Edition©

Pharmacy Education Source, LLC and The Law Office of Peter P. Cohron
Peter P. Cohron, BSPharm, JD
petercohron@gmail.com
PharmacyEducationSource@gmail.com
Cell: 859-227-9089

This law review handout is based on the “black letter law,” the law necessary for you to pass the
board examination. It does not entertain various scenarios from the “real world” nor discuss anything
other than the “black letter law.” From experience and discussions with others on this issue, the following
are the topics considered to be the most important and seen most often on the Kentucky multi-state board
jurisprudence exam.
Some headings have been provided but that is no guarantee that everything regarding that title is
under it. Federal, KRS and KAR citations are added for me as I look for updates in the law before each
year’s review is produced; there has never, to my knowledge, been a question on the pharmacy law exam
requiring a citation to a specific regulation or statute.
The information on this handout reflects what will be on the law exam. Some recent changes in
the law that should not be on the exam are covered and there is a NOTE about that. You are not
examined on recent changes—these must be in effect for one year prior to their being on the MPJE.
This year’s Review (2020) has been modified as best as possible to reflect this year’s changes in
the MPJE.

Disclaimer: This review is written and has the sole goal of aiding you in passing the KY MPJE.
This review is a “distillation” of pharmacy law; I have taken out the “legalese” to make the law easier to
understand. Thus, it is not exact; certain parts of the law I consider unnecessary have been reworded or
omitted. This is a review for a board examination (the KY MPJE) and should only be used for that
purpose. It should not be used or relied on as a substitute for a true copy of the state and federal
laws governing the practice of pharmacy. It is not a true copy of the Kentucky Pharmacy Practice Act
or the Controlled Substance Act. Keep in mind that the law changes; I have made every effort to be up to
date but do not guarantee that recent changes in the law are included.
More than 98% of persons using my materials pass the Kentucky MPJE on their first attempt. I
sincerely believe that knowing the contents of this law review is sufficient to pass the exam. I merely shy
away from promising you that you will score 100%. Further, I back away from guaranteeing a very high
grade as the 2016 MPJE Competency Statements were revised for the exam this year. I have reviewed
these statements and revised this review and practice exam to fit those to the best of my ability. You can
review these statements at nabp.net/programs/examination/mpje/mpje-blueprint
COPYRIGHT, February 2020 by Peter P. Cohron, BSPharm, JD. Any unauthorized use or copying of
this material subjects the person doing so to appropriate legal action.

BOARD OF PHARMACY

*peripheral control over pharmacy, at best

The Board of Pharmacy–six members, appointed by the Governor.
Five members are pharmacists; one is a citizen at large—all must be in good standing w/ the Bd,
all must be KY residents, no two RPhs from the same county
Board members serve a term of four years—the Bd member may be reappointed once
The Board elects a president (and other officers as it deems necessary) on an annual basis. An
officer may serve in a capacity for two years.
The Board is required to meet at least four times a year. Four members constitute a quorum.

Duties: The Board is authorized to
–set time and place for examinations, at least two exams yearly
–approve approved colleges of pharmacy
–promulgate administrative regulations pertaining to pharmacists, interns,
technicians, pharmacies, wholesale distributors and manufacturers
–schedule and conduct hearings
–issue and renew licenses
–investigate complaints
–employ an executive director. The executive director must be a pharmacist.

The Purpose of the Board is to protect the public by regulating the profession

210 KAR 2:061 Complaints to the Board.
Complaints may be oral, electronic or written from any source (layman, customer, another
pharmacist, law enforcement). Complaints and action may be taken against
–the pharmacy            –the PIC
–the pharmacist         –the technician
–depending on the issue, the intern

Upon receipt of a complaint, the Board shall instruct its staff to conduct an investigation.
Recommendations following an investigation shall be a 1) reprimand or 2) the issuance of a formal
complaint, order and notice of hearing (though not listed, it is assumed the matter could also be dropped).
Steps:
1. Agreed Order—written statement the pharmacist and Board can sign and the matter is
over and done with. Violation and punishment are ID’d in the document. Notice must be provided and
the pharmacist must be offered an opportunity to seek legal counsel
2. Administrative conference: pharmacist, attorney (if desired), Exec Dir, inspector who did
investigation
3. Settlement conference between the pharmacist’s attorney and the Board’s attorney may be
requested and held in an attempt to resolve the complaint
4. Hearings: a hearing officer presides and has authority to rule on all motions, control the
procedure of the hearing, and include or exclude evidence.
–Board, if taking a part, deliberates on all cases in closed session.

Disciplinary action may include suspension of license, revocation of license, fines, additional CE, jail

Pharmacists who commit minor violations may request the Board after three years to expunge their
records. Eg, failure to obtain required CE, failure to timely renew license

KRS 217.155 Each pharmacy inspector shall be a registered pharmacist.

KRS 315.126 PRN or Pharmacists Recovery Network. Assists pharmacists, technicians, and interns
impaired by drugs, alcohol, mental illness or physical incapacity. Report of impairment cannot be basis
for disciplinary action if no other pending complaints

Example test question: Pharmacist self-reports to PRN and the Board that she has a drug issue. She has
been stealing and taking benzos and gabapentin with no legitimate prescription. Her record at the Board
office is clean and clear.
I. She must surrender her license while doing detox/rehab
II. PRN will oversee her recovery
III. The Board must return her license if she does as PRN commands
a. I & III
b. I & II
c. II & III
d. All of the above
The correct answer is d

PHARMACISTS, TECHS, INTERNS

KRS 315.030 A person must have a license issued by the Kentucky Board of Pharmacy in order to hold
oneself out as a pharmacist. The license must be renewed annually, the license expiring on a date set by
the Board currently February 28 of each year. A reasonable fee may be assessed.

KRS 315.110 The pharmacist’s license must be conspicuously displayed at the pharmacist’s primary
practice site–the pocket license must always be in the possession of the licensee when practicing
pharmacy. The license will be marked “Preceptor” if the pharmacist is a preceptor.

KRS 315.050; 201 KAR 2:020 In order to obtain a pharmacist’s license, an applicant must:
–be at least 18 yrs old
–good mental health, moral character
–a graduate of a Board approved college of pharmacy
–have completed the requirements of internship
–must achieve at least 75 percent on the jurisprudence examination
at least 75% on the NABP examination
–background check
–Must register with KASPER
–must register with CPE monitor

KRS 315.065; 210 KAR 2:015 Continuing education requirements. In order to renew a pharmacist’s
license, must have completed 15 hours (1.5 CEU) of continuing education each year.
–NO carryover from one year to the next
–Records of CEU must be kept for 3 three years.
–Time period for CE is Jan 1 to Dec 31.
–Must register with NABP and get CPE monitor number

KRS 315.050, 315.191; 201 KAR 2:040 Internship
–must be in an approved college of pharmacy
–shall register with the KY Board of Pharmacy
–the minimum period of internship is 1500 hours
–the regulation now allows students to obtain all their internship during 4th year rotations
–maximum of 400 hours internship may be obtained for “work or research related to the practice
of pharmacy”
–intern shall have registered ID card on his or her person during all times of internship
–certificate ID card good for 6 years—card is good only when actively enrolled in an approved
school of pharmacy, on a planned (usual) break from school, due to circumstances beyond the control of
the student, while awaiting licensure examination, or awaiting licensure examination results
Intern dispensing responsibilities
–after 1st yr of pharmacy school: supervision of professional acts
Graduate interns may do all delegable pharmacist duties except they may NOT do the final verification

Preceptors–preceptor shall be a registered pharmacist who has been licensed by the Board for at least
one year,
a preceptor may supervise only one intern at a time, unless supervising more than one as a community
based faculty member. The preceptor must be actively engaged in the practice of pharmacy in the
location where the intern does internship

201 KAR 2: 205 Pharmacist-in-charge
The PIC accepts responsibility for the operation of the pharmacy, its conformance with the law
and is personally in “full and actual charge” of the pharmacy.
The PIC must be designated on the pharmacy permit.
A PIC may only be PIC of one pharmacy at a time (an exception to this is allowable upon request
to the Board and an exemption granted). He or she must be physically present at that pharmacy at least
10 hours per week.
Responsible for:
–quality assurance
–procurement, storage, safety, security and disposition of drugs and providing pharmacy
services
–seeing to it that all pharmacists/interns/technicians are currently licensed
–making and filing reports required by law
–notifying the Board within 14 calendar days of any change in PIC, changes with other
pharmacists or change in pharmacy hours.
–responding to Board identified violations/deficiencies
A PIC of a drug manufacturer must do quarterly inspections

KRS 315.121 Pharmacists have a duty to report the conviction of a felony, pharmacist incompetence,
fraud/deceit in obtaining a license, or any information that a pharmacist, intern, tech has diverted or
illegally distributed drugs, physical or mental disability whether or not caused by drugs or alcohol,
violation of a Board order.

Similarly, a pharmacist has a duty to self-report a felony conviction (not merely limited to drugs) within
30 days of that conviction

KRS 217.815 A pharmacist is allowed to give his or her professional opinion to a patient regarding the
capabilities, effectiveness and acceptability of any drug.

201 KAR 2:210 Patient Records and Patient Counseling
A/K/A OBRA 90
Patient records
A pharmacist or designee shall obtain pertinent patient information which shall be readily retrievable and
show the pharmacist previously dispensed drugs and known disease states, shall also require the
pharmacist to perform a prospective DUR with the newly dispensed drug. Information in the record shall
include:
patient’s full name
address & telephone number
age or date of birth
gender list of all Rxs obtained in the previous 12 months
known disease states
drug allergies
Patient records are confidential; this does not include counseling.
Counseling
–pharmacist (or designee) shall offer to counsel on new prescriptions and refills when
professional discretion dictates
–counseling shall be done by the pharmacist
–counseling may be done face-to-face or over telephone
–counseling shall include:
drug name, dosage form, route of administration, proper storage, “common and clinically significant”
adverse effects, interactions or contraindications
Counseling for deliveries: the offer is made by the delivery person (the pharmacist-designee) and a
signature is obtained on a sig log; counseling is done over the phone
Counseling for inpatients—only with discharge meds, not inpatient meds
–Documentation is required only if a patient refuses offer to counsel; no documentation is a
presumption that the offer to counsel was made, accepted, and counseling took place. Record of refusal
must be kept for 1 yr

902 KAR 2:020 Pharmacist must report to the local health department when they see a patient with
tuberculosis. Other diseases include measles, cholera, E coli, rabies, rubella, diphtheria
SB 101 pharmacist authority to administer immunizations is expanded
–all CDC recommended vaccinations beginning at age nine

201 KAR 2:045 Pharmacy technician.
A pharmacy tech must be under the immediate supervision of a pharmacist, ie, physical and visual
supervision.
A certified pharmacy tech requires only general supervision–the pharmacist must be on the premises.
Certified techs may certify med carts, initiate or receive refill authorizations and receive diagnostic orders
in a nuclear pharmacy. No new prescriptions. The law also does not indicate the number of techs a
pharmacist may supervise at one time
All technicians (certified or not) must register with the Board. Registration is annual—registration expires
March 31–and there is a $25 fee. As yet, there are no educational requirements (techs need not be
certified nor do CE)

201 KAR 2:380. Board authorized protocols.
This administrative regulation establishes procedures for board authorized protocols by which pharmacists
may initiate the dispensing of noncontrolled medications or other professional services.

OTC Probiotics

Example test question: A technician steals controlled substances from the pharmacy. When discovered,
the tech is fired.
a. Certified pharmacy technicians must be under immediate supervision of a pharmacist
b. Pharmacy techs must be under immediate supervision when working with CS
c. The PIC may be held responsible by the Board
d. As the pharmacist is responsible for the tech, the pharmacist on duty is solely responsible for the
theft
The correct answer is c
Example test question: Patient brings in a new prescription for lisinopril, a medication patient has been
on for three years previously.
a. The pharmacist must offer to counsel
b. Documentation of the offer must be acknowledged by a signature
c. No counseling is required as the patient has been on the medication previously
d. Documentation of a refusal of counseling is required
The correct answer is d

PHARMACIES

KRS 315.035 In order to operate a pharmacy a permit must be obtained. The permit must be renewed
annually, the permit expiring on June 30th of each year. A reasonable fee may be assessed. Each
separate location must have an individual permit.

KRS 315.0351 Out-of-state pharmacies which do business within Kentucky must:
–have a KY permit to operate
–shall comply with all statutorily authorized requests for information
–maintain readily retrievable records
–provide a toll-free telephone number available during business hours
–shall have a pharmacist-in-charge
–may seek a waiver to licensure if the number of Rxs sent in KY is minimal

201 KAR 2:090 required reference material and equipment
***Must have one from each category***
Category I-Pharmacology
Category II-Drug interactions
Category III-Drug Product Composition
Category IV-Laws and Regulations
Computer references are allowed if the reference can be used without interrupting the Rx filling process.
The Internet does NOT count.

Equipment
Prescription Class A Balance
Weight set
Graduates 1ml to 250ml
Mortars & pestles-glass, porcelain, or wedgewood
Spatulas-steel and nonmetallic
Refrigerator
Ointment slab or papers
Heating unit
Filtration funnel with filter papers

201 KAR 2:300 Common Database—means info shared between pharmacies for purpose of dispensing
Rxs or patient care
–pharmacies must have common ownership
–database must info re: all pharmacists & techs involved in filling a RX
–must have written policy & procedure manual
–use of a common database shall not constitute a transfer

201 KAR 2:106 Pharmacy, manufacturer, or distributor closures
1. Permanent closure ceases to do business permanently
30-day notice (sign) prior to closure and left in place until 30 days after closure–sign must say
where prescription records have been transferred—exception for transfer of records less than 5 miles
15-day written notice to Board, DEA and CHFS
All signs pertaining to pharmacy removed
Maintain records for 2 yrs
a. Involuntary closure means an interruption of formal business activity due to
–acute illness death natural disaster bankruptcy court or Board action
–no desire to close
–written notice to Bd within 5 days
–may maintain the premises for up to 60 days
–Bd may seize drugs if no sale made in 60 days
b. Voluntary closure means a closing or abandonment of business from
–chronic illness deviation from posted hours over 5 consecutive days ***any reason that is not
permanent or involuntary
–failure to resume normal operations within 60 days or KY Bd shall close store & seize drugs
Upon closing the pharmacy permit must be returned to the Board

2. Temporary closure:
–Pharmacy must be closed if no pharmacist present.
–Employees may not enter pharmacy nor conduct any pharmacy business.
–All files, drugs, and prescriptions must be secured. However, prescriptions may be deposited in
the pharmacy.
–If the pharmacy is closed and the rest of the store is open, there must be a floor to ceiling
partition that is locked and closed

201 KAR 2:170 A pharmacist’s signature on a daily printout or daily log containing all the information
about the pharmacist’s prescription filling activities is an acknowledgment that it has been reviewed and
is considered to be correct.
If the signature is on a daily log rather than printout, the Board must give permission to do this.
The daily log must be retained for 5 yrs.

Central (re)fill pharmacy pharmacy located in KY that provides packaging, labeling and delivery of a
refill to another KY pharmacy
–both pharmacy addresses & names on label
–original pharmacy must have patient contact info
–written contract or common ownership

Charitable pharmacies shall comply with all pharmacy requirements but may petition the Board in
writing to be exempt from any requirement not pertaining to the operation of that pharmacy
–only legend drugs
–no controlled substances
–may not charge any fee
–may accept prescription legend drugs for distribution in unbroken original package

201 KAR 2:074 Hospital Pharmacy and all institutional pharmacies
–there shall be a pharmacist designated as the “director of pharmacy”
–there shall be additional pharmacists and non-pharmacist personnel required to operate safely—
there must be written job descriptions
–there shall be a pharmacist with immediate supervision over every decentralized section of the
hospital pharmacy
–the services of a pharmacist must be available at all times, with a pharmacist on call if the
pharmacy is not open 24 hours a day
–floor stocks of drugs are allowed but the amounts must be minimal—must be essential to proper
treatment of emergencies
–a pharmacist must be a member of the hospital’s P & T committee
–may stock manufacturer drug samples
References related to the following subjects shall also be available:
(a) Drug identification;
(b) Toxicology;
(c) Drug interactions;
(d) Parenteral drug compatibility; and
(e) Microbiology.
Appropriate clinical information about patients shall be available and accessible to the pharmacist for use
in his daily practice activities

Drugs in the emergency room: includes drugs, including CS, that may be usual and customary in the
emergency situation. Along with Rxs to patients, drugs may be dispensed from a special “Pixel” machine
that will cover the patient for a reasonable amount of time until the patient can get to a pharmacy

902 KAR 55:070 Emergency boxes in Long Term Care Facilities
–The number is limited to 6 CS different drugs, no more than six dosage units, 30 non-CS drugs.
–Written policies & procedures;
–physician must order; pharmacy notified within 24 hours after box opened;
–physical inventory at least monthly
–the box must be kept in an area not accessible by patients or the public but accessible to staff
(ie, a nursing station)

Parenteral Compounding Pharmacy
must have a policy and procedure manual available for inspection
shall have an area specially designated for parenteral compounding
laminar airflow hood or Class 100 room
pharmacists must be licensed in the state of KY but also be knowledgeable in the specialized
functions of preparing and dispensing parenterals
parenteral profile shall be kept separate from other prescription files

Nuclear Pharmacy
pharmacy providing radiopharmaceutical services
must be under the direction of a nuclear pharmacist who shall be physically
present in the preparation area whenever support personnel are preparing radiopharmaceuticals—a
nuclear pharmacist is one who meets minimal standards of training and experience in the handling of
radioactive materials in accordance with the requirements of the Radiation Control Branch of the Cabinet
for Human Resources.
exempt from general space requirements
radiopharmaceuticals must be kept separate from other medications

201 KAR 2:225 Special pharmacy medical gas pharmacy: oxygen & nitrous oxide
–must have a special pharmacy permit
–must have a PIC but is not required to be on site 10 hrs per week—may be PIC for multiple locations
–must inspect medical gases at least quarterly
–must have written policy & procedure manual detailing security and following state & federal laws
–medical gases do require a prescription—Q on refills—one year

201 KAR Clinical Pharmacy
–does not fill Rxs
–must have a PIC and all required reference books
–can seek to be exempted from Rx sanitation requirements, Rx equipment requirements
–policy and procedure manual updated annually
–Patient records which are readily retrievable and maintained for five years
–physical address

KRS 315.300, 902 KAR 55:115 Drugs in hospice or home health agencies
A pharmacy may store drugs in a home health agency if the drugs are to be dispensed to patients,
a written agreement exists, the home health employees are licensed to administer drugs, and the
pharmacy’s PIC approves.
Records for these drugs must be retained for 5 yrs
The drug inventory is limited to
sterile water for irrigation or injection
sterile saline for irrigation or injection
heparin flush
diphenhydramine inj.
epinephrine inj. glucagon
flu vaccine
pneumonia vaccine

21 CFR 1301 A pharmacy that is a DEA registrant may not employ any person who has been convicted
of a felony related to controlled substances unless the DEA issues a waiver. Waivers are specific to each
employer and each employee.

201 KAR 2:105 Requirements for drug manufacturers and wholesalers
–A license is required by the Board. A CHFS-Drug control license is required if controlled substances
present (& of course, a DEA license).
–Each separate location must have a license.
–adequate maintenance and storage conditions with log books to record proper storage of prescription
drugs. Records must show accurate and precise accounts of all goods shipped or received.
–adequate lighting and environmental controls
–A pharmacist must supervise manufacturing.
–Prescription drugs may only be sold to currently licensed entities.
Prescribers pharmacies hospitals labs
–There shall be an alarm system and access to prescription drugs must be limited.
–there must be written procedures for handling and disposal of returned goods
–there must be written procedures for handling recalls and withdrawals for the market
_____________________________________________________________________________________
Past graduates taking this review suggested more on manufacturers even though they PASSED the exam
on their first attempt. I recommend that you read through this regulation at least one time.

201 KAR 2:320. Permit requirements for manufacturers.
Requirements. (1) A manufacturer shall apply for a permit from the board
(2) A separate permit shall be required for each facility

A permit shall not be issued or renewed unless the applicant or its officers demonstrates or continues to
demonstrate acceptable operational procedures, including:
(a) Adequate maintenance and storage conditions to ensure proper lighting, ventilation, temperature and
humidity control, sanitation, space, and security as per label requirements or current year United States
Pharmacopoeia (USP) compendium requirements.
(b) Physical separation and quarantine of deteriorated, damaged, outdated, misbranded, adulterated, or
otherwise recalled merchandise until they are destroyed or returned;
(c) Providing accurate and precise records of all goods shipped or received including source or recipient,
date, quantity, itemized description
(d) Providing proof of registration with the state controlled substance authority & DEA

Qualifications for Permit. The Kentucky Board of Pharmacy shall consider
1. Any convictions of the officers of the applicant under any federal, state, or local laws;
2. The applicant’s past experience in the manufacture of prescription drugs, including controlled substances;
3. The furnishing by the applicant of false or fraudulent material in any application made in connection
with drug manufacturing;
4. Suspension or revocation by federal, state, or local government of any license or permit currently or
previously held by the applicant
5. Compliance with the requirements under any previously granted license or permit
6. Compliance with requirements to maintain or make available to the Kentucky Board of Pharmacy or to
federal, state, or local law enforcement officials those records required under this section.
(b) The Kentucky Board of Pharmacy shall have the right to deny a permit to an applicant or its officers if
it determines that the granting of that permit would not be in the public interest for any reason established
in KRS 315.121.
A permit shall not be issued unless the applicant has furnished proof satisfactory to the Board of Pharmacy:
(a) That the applicant is in compliance with all applicable federal and state laws and regulations relating to
drugs; and
(b) That the applicant and its officers are equipped as to land, buildings, and security to properly carry on
the business described in the application.

A permitted manufacturer may sell or distribute federal legend drugs only to the following:
(a) A currently permitted manufacturer;
(b) A currently licensed wholesale distributor;
(c) A currently permitted pharmacy;
(d) A currently licensed practitioner;
(e) A currently licensed hospital, but only for use by or in that hospital; or
(f) A person in charge of a laboratory, but only for use in that laboratory for scientific and medical research
purposes.

An application for a permit shall be submitted to the Board of Pharmacy on Application for a Permit to
Operate as a Manufacturer (KBP M 5:09).
An application shall be accompanied by the annual fee.
An application shall include:
(a) The name, full business address, and telephone number of the applicant;
(b) All trade or business name used by the applicant;
(c) Addresses, telephone numbers, and the names of the contact persons for the facility used by the permittee
for the storage, handling, and manufacturing of prescription drugs;
(d) The type of ownership or operation (i.e. partnership, corporation, or sole proprietorship);
(e) The name(s) of the owner and operator of the permittee, including;
1. If a person, the name and Social Security number of the person;
2. If a partnership, the name and Social Security number of each partner, and the name of the partnership;
3. If a corporation, the name, Social Security number and title of each corporate officer and director, the
corporate names, and the name of the state of incorporation; and
4. If a sole proprietorship, the full name and social security number of the sole proprietor and the name of
the business entity; and
(f) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant
to manufacture or possess prescription drugs.

All permits shall:
(a) Expire on September 30 following the date of issuance; and
(b) Be:
1. Renewable annually thereafter upon proper application accompanied by the renewal fee set forth in 201
KAR 2:050; and
2. Nontransferable.
Standards. (1) Facilities.
(a) All buildings in which legend drugs are repackaged, stored, held, sold, offered for sale, exposed for sale,
or kept for sale shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and
proper operations.
(b) Buildings shall meet all applicable federal, state, and local standards. The facility shall have a quarantine
area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated,
or that are in immediate or sealed secondary containers that have been opened.
(c) A facility shall not be located in a residence.
(2) Security.
(a) A manufacturer shall be equipped with an alarm system to detect entry after hours.
(b) A manufacturer shall ensure that access from outside their premises is well-controlled and reduced to a
minimum. This includes the installation of adequate lighting at the outside perimeter of the premises.
(c) Internal security policies shall be developed to provide reasonable protection against theft and diversion
by limiting access to areas where legend drugs are held to authorized personnel. These policies shall provide
protection against tampering with computers or electronic records.
(d) A permit holder shall employ adequate personnel with the education and experience necessary to safely
and lawfully engage in the manufacturer of prescription drugs.
(e) Lists of officers, directors, managers and other persons in charge of distribution, storage, and handling
of prescription drugs, including a description of their duties and summary of their qualifications, shall be
maintained for purpose of review.
(3) Recordkeeping.
(a) Inventories and other records of transactions regarding the receipt and disposition of legend drugs shall
be maintained and readily available for inspection or photocopying by authorized law enforcement officials
for a period of two (2) years following disposition of the drugs. These records shall include:
1. The source of the drugs including the name and principal address of the seller or transferor and the
address of the location from which the drugs were shipped;
2. The identity and quantity of the drugs received and distributed or disposed of; and
3. The dates of receipt and distribution or other distribution of the drugs.
(b) Records described shall be readily available for authorized inspection during the retention period.

Written policies and procedures.
(a) A manufacturer shall establish, maintain, and adhere to written policies and procedures for the receipt,
security, storage, inventory, and distribution of prescription drugs, including policies and procedures for
identifying, recording, and reporting losses or thefts and to ensure that the manufacturer prepares for,
protects against, and handles crisis situations that affect the security or operation of the facility. These crises
shall include fires, floods, or other natural disasters, and situations of local, state, or national emergency.
(b) There shall be written policies and procedures for managing and correcting all errors or inaccuracies in
inventories.
(c) There shall be written policies and procedures to assure that any outdated stock or any stock with an
expiration date that, in the manufacturer’s view, does not allow sufficient time for repacking or resale shall
be segregated from other stock and shall be prepared for return or otherwise destroyed, and this shall be
documented.
(d) There shall be written policies and procedures by which the manufacturer exercises control over the
shipping and receiving of all stock within the operation.

Returned, damaged, and outdated prescription drugs. A manufacturer’s operation shall maintain and follow
a written procedure to assure the proper handling and disposal of returned goods. If conditions under which
a prescription drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity,
then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other