Kentucky Law Regarding Compounding for a Practitioner's Office or Institutional Administration

201 KAR 2:310. Compounding for a practitioner’s office or institutional administration.
RELATES TO KRS 315.191(1)(a).
STATUTORY AUTHORITY: KRS 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) requires the board to
promulgate administrative regulations to regulate and control all matters relating to
pharmacists, pharmacist interns, pharmacy technicians, and pharmacies. This administrative
regulation addresses compounding for use by a practitioner’s office administration or
institutional administration.
Section 1. A pharmacist, pharmacist intern, or pharmacy technician may prepare a
compounded drug for a practitioner’s office administration or institutional administration.
Section 2. A compounded drug that contains a controlled substance shall not be
compounded for office or institutional administration.
Section 3. The pharmacist shall receive a written, verbal, facsimile, or electronic request for
a compounded drug from a practitioner, indicating the formulation, strength, and quantity
ordered.
Section 4. Label Requirements. A label shall be generated for the compounded drug and
shall include:
(1) The name of the practioner;
(2) The designated name and strength of the compounded drug;
(3) The quantity dispensed;
(4) A lot or batch number of the compounded drug;
(5) The beyond use date for the compounded drug;95
(6) The date the compounded is dispensed;
(7) The pharmacy's name, address, and telephone number;
(8) Any special storage requirements;
(9) A notation stating "For Office or Institutional Administration Only-Do Not
Dispense to Patient;
(10) Any auxiliary label required for the compounded drug.
Section 5. The compounded drug shall be administered in the practitioner’s office or
institution and shall not be dispensed to the patient.
Section 6. The prescription for the compounded drug shall be kept pursuant to 201 KAR
2:170.
(35 Ky.R. 1954; 2006; eff. 3-11-09.)

Found here.

Maine Board of Pharmacy's Position on Office Use

The Maine Board of Pharmacy Minutes of the June 7, 2012 meeting contain the following information regarding office use of compounded preparations in that state:

E-Correspondence of May 18, 2012, David Kosar, regarding dispensing to a practitioner for office use

The Board concluded that compound products are only for a specific patient’s immediate need and anything outside of this would rise to the activity of manufacturing. A pharmacist cannot sell compounded product to a practitioner.

These minutes of the meeting can be found here.

Hawaii Board of Pharmacy Examines Definition of Office Use for Compounds

During the June 21, 2012, Hawaii Board of Pharmacy Meeting, the Board examined  what the state laws in Hawaii pertaining to "office use" for sterile and non-sterile compounding.  The following discussion is recorded in the meeting minutes:

Questions on Hawaii Compounding Laws

The Chair read the email inquiry from a pharmacy student at the University of New Mexico asking:

1. What are the state laws in Hawaii pertaining to “office use’ for sterile and non-sterile compounding? Can 

pharmacies in Hawaii compound preparations in advance that prescribers can use in their office without a patient-specific prescription for either (or both) sterile and non-sterile compounds?

2. Has Hawaii recently amended their laws so that compounding pharmacies may
help with the drug shortage crisis?

Mr. Inafuku stated that HRS 461-15 under the miscellaneous permit, (a)(6) states, “For any person, as 

principal or agent, to conduct or engage in the business of preparing,manufacturing, compounding, packing, 

or repacking any drug without first obtaining a permit from the board to do so;”.

The Vice Chair stated that pharmacies may not compound a product unless they have a patient specific 

prescription.

Mr. Inafuku stated that a miscellaneous permit holder who compounds will still be subject to FDA 

requirements.

The Vice Chair stated it’s compounding vs. manufacturing. A compounded product is
manufacturing but a pharmacist may compound a product pursuant to a pahent specific prescription and that compounding for office use is considered manufacturing.

That was the consensus of the Board.

These board minutes can be found here.

"Office Use" in Tennessee: Does this Apply to Compounded Drugs?

This article appeared in the Tennessee Board of Pharmacy January 2012 newsletter, which is found here:

Understanding the Correct Transfer for ‘Office Use’
Pharmacists have often asked how to follow the proper procedures
when transferring a medication to another pharmacy
or prescribing practitioner. Please note that the only place in
the Tennessee Board of Pharmacy rules that mentions “office
use” is in Rule 1140-06-.02 (5), which states “ . . . A nuclear
pharmacy practice site may also furnish radiopharmaceuticals
for office use to authorized practitioners for individual patient
use . . . ”
Therefore, what is allowed? Refer to Tennessee Board of
Pharmacy Rule 1140-09-.01, which states:
“ . . . (3) The requirement of a license [referring to a
Manufacturer/Wholesaler license] shall not apply to
the following types of distributions . . . [*](i) The sale,
purchase or trade of a prescription drug, or an offer
to sell, purchase or trade of a prescription drug by a
pharmacy practice site to another pharmacy practice
site or to authorized prescribing practitioners, except
that the total gross dollar volume of such transfers
shall not exceed five percent (5%) of the total medical and
prescription orders sales revenue of either the
transferor or transferee pharmacy during any twelve
(12) consecutive month period . . . ”
Therefore, instead of transferring pursuant to a prescription
for “office use only,” pharmacists are advised to invoice
the medication or medical device while complying with section (i),
and hold this readily retrievable record for two years.
In this manner, the medication can then be delivered to the
prescribing practitioner’s office or pharmacy.
Furthermore, the rules change/add when dealing with a
controlled substance. For a Schedule II medication, Drug
Enforcement Administration (DEA) Form 222 must be
completed between the seller and buyer, while one copy is
kept in the pharmacy for two years per Title 21, Code of
Federal Regulations (CFR) 1307.11, which may be found at
the following Web link: www.deadiversion.usdoj.gov/21cfr/
cfr/1307/1307_11.htm. An invoice with the following information
must also be kept for Scheduled III through V medication
including the name, address, and DEA registration number of
both parties, the name, strength, quantity, and dosage form of
the drugs, and the date of the transaction, pursuant to CFR
1304.22. CFR 1304.22 may be found at the following Web
link: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.
htm. It is advised to obtain a signature of each registrant
on the invoice. This record must be kept for two years per
DEA CFR 1304.04., found at the following Web link: www
.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm.
According to CFR 1307.11, the pharmacy must make certain
that the distribution “. . . does not exceed 5% of total dosage
units of controlled drugs dispensed and distributed during the
same calendar year unless licensed as a distributor by DEA .
. . ” This regulation is in addition to the Tennessee Board of
Pharmacy rule stated previously, which refers to 5% of total
order sales revenue. (See asterisked section of Rule 1140-
09-.01 referenced at the beginning of this article.)

New Rules in Texas Relating to Veterinary Compounding

The Texas State Board of Veterinary Medical Examiners have adopted rules impacting veterinarian compounding in Texas.  A complete set of all the new rules adopted in Texas can be found here.  The following rule was adopted in the Spring of 2012 and became effective June 14, 2012.  The rules are intended to limit veterinarians from compounding significant quantities of drugs in advance of diagnosis for business profit reason without having established a veterinarian-client relationship  for the patient and diagnosing a condition or disease in that patient.  The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs.  The new rule 573.44 provides:

 RULE §573.44 COMPOUNDING DRUGS
(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(b) A veterinarian may only prescribe compounded drugs to treat a specific occurrence of a disease or condition, which threatens the health of the animal or will cause suffering or death if left untreated, that the veterinarian has observed and diagnosed in the particular patient for whom the compounded drugs are prescribed. The amount of a drug that a veterinarian compounds or orders compounded must not exceed the established need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(c) Labeling Requirements.
(1) All compounded drugs must bear the labeling information required under §573.40 of this title (relating to Labeling of Medications Dispensed), as well as the following information:
(A) date on which the drug was compounded;
(B) name and strength of medically active ingredients;
(C) identity of treated animals;
(D) withdrawal/withholding times if needed; and
(E) condition or disease to be treated.
(2) In addition to the information listed in paragraph (1) of this subsection, compounded drugs dispensed to the client must also state a date dispensed and an expiration date, which should not exceed the length of the prescribed treatment.
(d) Limitations on Compounded Products.
(1) A veterinarian shall not compound or order a drug compounded if there is a FDA-approved,
commercially available animal or human drug that, when used as labeled or in an extra-label fashion in its available dosage form and concentration, will appropriately treat the patient.
(2) A veterinarian shall only compound or order compounded products with FDA-approved commercially available animal or human drugs as the active ingredients.
(3) A veterinarian shall not promote and/or distribute compounded drugs that are essentially similar to FDAapproved products.
(4) A veterinarian must ensure the safety and efficacy of a compounded drug, including but not limited to avoiding known drug incompatibilities and inappropriate combinations, and must use a pharmacist to perform drug compounding when the complexity of the compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.
(e) Compounding for Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval for the compounded product sufficient to ensure food safety and may not compound from any drugs prohibited for use in food producing animals. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not compound or order a drug compounded if the compounded drug results in
violative food residue, or any residue that may present a risk to public health.
(3) Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for compounding.
(4) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
(f) Limitations on Promotion and Sale of Compounded Drugs.
(1) A veterinarian shall not prepare for sale any compounded drugs which employ fanciful names or trade names, colorings or other additives, or that in any way imply that the compounds have some unique effectiveness or composition.
(2) A veterinarian shall not advertise, promote, display, resell, or in any other way market prepared
compounded drugs.
(3) A veterinarian shall not offer compounded drugs to other state licensed veterinarians, pharmacists or other commercial entities for resale.
Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229

Here are the boards comments, which can be found here,  on that new rules:

22 TAC §573.44

The Board adopts new §573.44, regarding Compounding Drugs, which sets out the limited circumstances in which a veterinarian can compound a drug.  The adopted new rule parallels current state and federal regulations on the compounding of drugs by veterinarians while emphasizing issues that are of particular significance for veterinarians, such as the importance of the veterinary-client-patient relationship and the limitations on drugs compounded for foodproducing animals. The adopted rule is structured by subject-area, to clarify the limitations that apply to all compounded products, the limitations on compounding for food producing animals, and the limitations on promotion and sale  of compounded drugs. The new adopted rule strengthens the requirement that a veterinarian must establish and maintain a veterinarian-client
-patient relationship with any animal for which the veterinarian compounds drugs. The Board intends the adopted rule to limit drug compounding by veterinarians only  to treat a specific occurrence of a disease or condition that the veterinarian has diagnosed in a specific patient, and to prohibit veterinarians from compounding on any other basis or in quantities greater than those needed for the treatment of the particular disease occurrence in the specific diagnosed patient.   The Board's concern is that some  veterinarians compound significant quantities of drugs in advance of diagnosis for business profit reasons without first diagnosing the condition or disease the compounded drug is designed to treat in a particular patient with whom the veterinarian has established and maintained a  veterinarian-client-patient relationship. Compounding drugs for
office use is allowed under the rule, but only in amounts that do not exceed the established historical need for specific compounded drugs  for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship. The adopted rule includes more detailed provisions requiring that a veterinarian only compound products made with FDA-approved drugs as active ingredients, and not promote or distribute compounds that are essentially the same as other FDA-approved drugs. The subsection of the adopted rule regarding compounding for food-producing animals parallels existing federal and state law on the subject by requiring that the veterinarian set withdrawal times that are based on scientific
information and note the method used to determine the withdrawal period in the patient records, and ensure that procedures are in place to maintain the identity of any food-producing animal that receives a compounded drug. With regard to labeling requirements for compounded drugs, the new adopted rule eliminates redundancies in the labeling information required for all drugs under §573.44, and requires that the label for  compounded drugs include both name and strength of medically active ingredients. 

RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:

(a) Extra-label or off-label use is the actual or intended use of a drug in an animal that is not in accordance with the approved labeling, and includes, but is not limited to:
(1) compounded drugs;
(2) use in species not listed in the labeling;
(3) use for diseases or other conditions not listed in the labeling;
(4) use at dosage levels, frequencies, or routes of administration other than those stated in the labeling; and
(5) deviation from the labeled withdrawal time based on these different uses.
(b) A veterinarian must use his or her discretion in the off-label use of drugs for animals. In exercising such discretion, a veterinarian shall consider, to the extent possible:
(1) whether the off-label use of a drug meets the community standard of humane care and treatment set out in §573.22 of this title (relating to Professional Standard of Care);
(2) the established safety of the off-label usage;
(3) the inclusion of a drug in a standard veterinary formulary;
(4) analyses of off-label usage in the veterinary medical literature and in articles and commentaries written by the veterinarian's peers in the veterinary medical profession;
(5) information provided by the drug's manufacturer, vendor or the FDA as to whether off-label usage of a drug may present a risk to public health; and
(6) any other sources of pertinent information

(c) If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the e health of the animal.

Any oral notification shall be recorded in the patient records.

(d) Extra-Label Drug Use in Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval sufficient to ensure food safety. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not prescribe an extra-label drug in a manner that will result in violative food residue, or any residue that may present a risk to public health.
(3) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
Source Note: The provisions of this §573.45 adopted to be effective June 14, 2012,

The board's comments about rule 573.45 are as follows.

22 TAC §573.45
The Board adopts new §573.45, regarding Extra-Label or Off-Label Use of Drugs, which sets out the conditions under which a veterinarian may prescribe a drug for an off-label use. The adopted new rule includes compounded drugs explicitly among the list of extra-label or offlabel uses for drugs. Although compounding is commonly considered an off-label use, some licensees have expressed confusion over whether the limitations on extra-label use applied to compounded drugs as well as approved drugs. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs set out in adopted new §573.44. 

Office Use Compounding in Florida

The following is a Powerpoint presentation on Florida's Inspection Criteria for Office Use Compounding in Florida.  To view the Powerpoint, click here.

Consulting Applicable Law: Federal and State

Both the state and the federal laws need to be consulted when dealing with compound medications.  An example of this is when one is dealing with "office use" or "office administration" of medications--both medications for humans and medications for animals.  In general, "office use"  or "office administration" of medications refers to "limited" or "reasonable" quantities and for administration in the office, institution or hospital.  This does not mean a doctor or veterinarian can dispense the medication to the patient.  To determine specifically if one is complying with applicable law, first consult your State Board of Pharmacy rules and regulations regarding "office use."  


Second, one should consult the state rules and regulations of any state where medications will be shipped or delivered to, if the medication, is not being shipped or delivered to one's home state.   For example, Oklahoma's rules allow the "office use" of compounded medications except for controlled substances as written in their state rules, which is the same as the United States Drug Enforcement Administration (DEA), patient-specific, controlled substance prescription requirement, which is discussed below.  Missouri's rules, on the other hand, strictly forbid the "office use" of compounded medications.  Whereas, Texas' rules allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. 

Third, you must consult any applicable federal law.  For example, 21 CFR § 1306.04 relates to the purpose of issue of prescription.  That section provides:

Section 1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. 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 prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) 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.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for “detoxification treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005]

The DEA does not recognize compounded, controlled substance medications ordered for "office use" or "office administration." Thus, controlled substance cannot be shipped to a doctor's office, but must be patient-specific and delivered directly to patients. 

What law applies to compounded medications is a tricky and developing area of the law.  It is essential that all involved in the chain dealing with compounded medications consult both state and federal law to ensure compliance with all applicable laws.

Website with Links to All the State Laws Relating to Compounding

The Compounding Pharmacy Compliance website contains links to all the state laws relating to compounding.  Click here to view the links. This website also contains other useful information.  For example, this website points out that Texas and South Carolina allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. The specific requirements that must be found in these contracts can be found in each state's rules.