Board of Pharmacy Positions Towards Flavoring

As of April 2024

While USP has always provided guidance that they consider medicine flavoring to be a form of compounding, it is State Boards of Pharmacy that regulate and enforce nonsterile compounding standards. 49 of 52 Boards of Pharmacy have determined that USP 795 nonsterile compounding standards do not apply to the simple practice of medicine flavoring, with most Boards saying they do not consider flavoring to be compounding at all.

Click on a state to read its policy toward flavoring, or use the drop down below.

Map Legend

Of note, Illinois says flavoring is not compounding in statute. Both NC BOP & MA BOP guidance says flavoring is compounding but only require documentation, not full USP 795.

85% of children between ages 0-11 live in states that do not subject flavoring to USP 795 standards.

88% of U.S. pharmacies operate in states that do not subject flavoring to USP 795 standards.

200 million medications have been flavored over the past 25 years without a single reported issue of harm.

In The News

Pharmacists in California Stop Flavoring Medication for Children Due to New Rules
New California rules target flavors in kids’ medication, leading pharmacies to end service

State Policies Towards Flavoring

Click on any state below to see how your state treats flavoring.

The Alabama State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Alaska Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Arizona Board of Pharmacy does not regulate flavoring as compounding.

The following substantive policy is in place:

  1. A pharmacist may add flavoring agents, up to a maximum of five (5) percent (%) of the total volume, to a prescription at the request of a patient, the patient’s caregiver, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented and maintain electronic or manual documentation of the flavoring agent and quantity added. Documentation of beyond-use-dates longer than fourteen days, including the flavoring agent and quantity added, shall be maintained by the pharmacy electronically or manually and made available to agents of the Board on request.

  2. The addition of flavoring agents over five (5) percent (%) of the total volume to a prescription requires the permission of the prescriber and compliance with the requirements of the Current Good Compounding Practices rule (A.A.C. R4-23-410).

The Arkansas State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The California State Board of Pharmacy does not currently regulate flavoring as compounding.

The Board has the following rule in place:

Article 4.5 Compounding 1735. Compounding in Licensed Pharmacies (a) “Compounding” means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription: (1) Altering the dosage form or delivery system of a drug (2) Altering the strength of a drug (3) Combining components or active ingredients (4) Preparing a compounded drug preparation from chemicals or bulk drug substances (b) “Compounding” does not include reconstitution of a drug pursuant to a manufacturer’s direction(s), nor does it include the sole act of tablet splitting or crushing, capsule opening, or the addition of flavoring agent(s) to enhance palatability.

However, this language is set to be stricken and the Board of Pharmacy plans to regulate flavoring to USP 795 standards.

More about California and flavoring

The Colorado State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

3.00.55 Prescription Flavoring. A flavor additive may be incorporated into a non-sterile prescription under the following conditions:

  1. The patient, patient’s caregiver, or practitioner who authorized the original prescription shall authorize the flavoring of each new and, if applicable, refilled prescription.

  2. The flavor additive shall in no way compromise the stability, safety, or efficacy of the dispensed drug.

  3. No expired flavor additive shall be incorporated into a prescription. No flavor additive shall be incorporated which will expire prior to utilization by the patient, based on the practitioner’s directions for use.

  4. For flavoring additives that do not have expiration dates assigned by the manufacturer or supplier, a pharmacist shall clearly and legibly label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt, to the flavoring additive. In no event shall the labeled date of receipt or assigned expiration date be later altered after originally labeling the container.

  5. The following information shall be recorded and maintained in a suitable hard-copy or electronic dispensing record for a period of two years from the date of flavoring the corresponding new or refilled prescription. This record shall be made available, in printed form, for the Board or its representatives immediately upon the request of the Board or its representatives. 1) Additive’s flavor; 2) Flavor additive’s manufacturer 3) Flavor additive’s lot number (if available); and 4) Flavor additive’s expiration date.

  6. The pharmacist responsible for conducting the final evaluation of a new or refilled prescription shall also be responsible for the flavoring of the prescription as specified in subsections a., b., and c. of this Rule 3.00.55.

  7. The pharmacist manager shall be responsible for subsection d. of this Rule 3.00.55 and the maintenance of records as specified in subsection e. of this Rule 3.00.55.

The Connecticut Commission of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Sec. 20-617a. Flavoring agent added to prescription product.

(a) For purposes of this section, “flavoring agent” means an additive used in food or drugs when such additive: (1) Is used in accordance with good manufacturing practice principles and in the minimum quantity required to produce its intended effect, (2) consists of one or more ingredients generally recognized as safe in food and drugs, has been previously sanctioned for use in food and drugs by the state or the federal government, meets United States Pharmacopeia standards or is an additive permitted for direct addition to food for human consumption pursuant to 21 CFR 172, (3) is inert and produces no effect other than the instillation or modification of flavor, and (4) is not greater than five per cent of the total weight of the product.

(b) A flavoring agent may be added to a prescription product by: (1) A pharmacist upon the request of the prescribing practitioner, patient for whom the prescription is ordered or such patient’s agent, or (2) a pharmacist acting on behalf of a hospital, as defined in section 19a-490.

(P.A. 12-12, S. 1.)

The Delaware State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The District of Columbia Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Florida Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

While the Georgia Board of Pharmacy is statutorily bound to adopt USP standards for compounding, they currently exercise enforcement discretion when it comes to the practice of flavoring medicines.

The Hawaii State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Idaho State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

  1. COMPOUNDING DRUG PREPARATIONS. Any compounding that is not permitted herein is considered manufacturing. (7-1-21)T 01. Application. This rule applies to any person, including any business entity, authorized to engage in the practice of non-sterile compounding, sterile compounding, and sterile prepackaging of drug products in or into Idaho, except these rules do not apply to: (7-1-21)T a. Compound positron emission tomography drugs; (7-1-21)T b. Radiopharmaceutics; (7-1-21)T c. The reconstitution of a non-sterile drug or a sterile drug for immediate administration; (7-1-21)T d. The addition of a flavoring agent to a drug product; and (7-1-21)T e. Product preparation of a non-sterile, non-hazardous drug according to the manufacturer’s FDA approved labeling. (7-1-21)T

The Illinois Board of Pharmacy does not regulate flavoring as compounding.

The following statute is in place:

(o) “Compounding” means the preparation and mixing of components, excluding flavorings, (1) as the result of a prescriber’s prescription drug order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice or (2) for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing.

The Indiana Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Iowa Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Compounding does not include the use of a flavoring agent to flavor a drug pursuant to rule 657—20.13(124,126,155A), nor does it include mixing or reconstituting a drug according to the product’s manufacturer label.

“Flavoring agent” means a therapeutically inert, nonallergenic substance consisting of inactive ingredients that is added to a drug to improve the drug’s taste and palatability.

657—20.13(124,126,155A) Use of flavoring agents. A flavoring agent may be added to a drug at the discretion of the pharmacist or upon the request of the prescriber, the patient, or the patient’s agent. The pharmacist may add flavoring agents not to exceed 5 percent of the total volume of the drug to which the flavoring agents are added. The pharmacist shall label the flavored drug with a beyond-use date no greater than 14 days past the date the flavoring agent is added if the drug is required to be stored in a refrigerator. A different beyond-use date or alternate storage conditions may be indicated if such variation is supported by peer-reviewed medical literature. The pharmacist shall electronically or manually document that a flavoring agent was added to a drug, and such documentation shall be made available for inspection and copying upon the request of the board or an agent of the board.

The Kansas State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Kentucky Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

201 KAR 2:076. Compounding.

Section 2. (1) All non-sterile compounded preparations shall be compounded pursuant to United States Pharmacopeia (USP) 795, unless specified portions submitted by a pharmacist have been waived by the board. Notwithstanding any USP guidance to the contrary, the addition of flavoring to a drug shall not be considered non-sterile compounding, if the additive:

(a) Is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor; and (b) Is not greater than five (5) percent of the drug product’s total volume.

The Louisiana Board of Pharmacy does not regulate flavoring as compounding.

The following guidance in place:

Louisiana Board of Pharmacy Policies & Procedures

Title: Addition of Flavors to Medications- Policy No. I.A.31

Resolved, that the Board adopt an enforcement policy, such that the addition of nonallergenic and inert flavoring agents to commercially available liquid oral products resulting in a change in the final product volume of less than 5% shall not require a prescriber’s order or a full compounding log.

The Maine Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Maryland Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Massachusetts State Board of Pharmacy regulates flavoring as compounding to USP 795 standards.

The Michigan Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

(e) “Compounding” does not include any of the following: (i) Except as provided in section 17748c of the code, MCL 333.17748c, the compounding of a drug product that is essentially a copy of a commercially available product. (ii) The reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved labeling provided by the manufacturer of a commercially available product. (iii) The compounding of allergenic extracts or biologic products. (iv) Flavoring agents added to conventionally manufactured and commercially available liquid medications. Flavoring agents must be nonallergenic and inert, not exceeding 5% of a drug product’s total volume.

The Minnesota State Board of Pharmacy regulates flavoring as compounding.

The Mississippi Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

C. For the purpose of this Article, the combining of commercially manufactured, ready to-use products shall be exempt from USP 795 compounding standards under the following conditions: i. No more than four (4) commercially manufactured ready-to-use products (that have not been manipulated) are used; ii. All products used are FDA approved; iii. Compounding is not done in anticipation of medication orders; iv. Must follow USP 795 beyond use dates (BUDs); v. A valid prescription shall serve as the compounding record; vi. The prescription label shall comply with the labeling requirements as set forth in Article XIV of these regulations and also include: (1) Name of Preparation; (2) Strength and concentration of each component; 2 (3) Beyond Use Date; (4) Special storage requirements, if applicable; and (5) Cautionary auxiliary labels, if applicable.

The Missouri Board of Pharmacy does not regulate flavoring as compounding.

The following guidance is in place:

H.12 FLAVORING

Licensees may flavor a legend product unless the prescriber indicates otherwise. OTC products may only be flavored by prescription. Licensees should indicate that the product was flavored on the patient’s container and the added flavoring must be documented in the pharmacy’s prescription record (e.g., in a flavoring book or in the prescription record). As defined by the Board’s rules, flavoring does not constitute compounding. Licensees may not flavor a prescription dispensed by another pharmacy.

The Montana Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Nebraska Department of Health and Human Services, Division of Public Health, Licensure Unit does not regulate flavoring as compounding.

The following rule is in place:

(4) Any authorized person splitting a scored tablet along scored lines or adding flavoring to a commercially available drug product is not engaged in compounding.

The Nevada State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The New Hampshire Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

“Compounding” shall not include the reconstitution of powdered formulations before dispensing or the addition of flavoring. “Compounding” shall not include the simple addition of flavoring, nor shall it include the preparation of a single dose of a nonhazardous commercially available drug or licensed biologic for administration within 2 hours of preparation to an individual patient when done in accordance with the manufacturer’s approved labeling or instructions consistent with that labeling.

The New Jersey State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

c) A compounding record shall not be required for:

1) Mixing, reconstituting, or assembling a drug according to the product’s labeling or the manufacturer’s directions; and

2) Product flavoring.

It is unclear how the New Mexico State Pharmacy Quality Assurance Commission will treat flavoring of conventionally manufactured medications moving forward.

The New York State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The North Carolina Board of Pharmacy does not regulate flavoring as compounding to USP 795 standards.

The following guidance is in place:

Adding flavoring to Conventionally Manufactured Products

Q. Is adding flavoring to a conventionally manufactured product considered compounding?

A. USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a pharmacy adds flavoring to a manufactured product it must take into account the manufacturer’s Beyond Use Date (BUD) and the effect on stability caused by adding flavoring. If a flavoring component is added to a manufactured product that does not contain a preservative (e.g.: reconstitution of amoxicillin oral suspension) the BUD is 14 days refrigerated or shorter if indicated in the manufacturer’s labeling. If a flavoring component is added to a manufactured product that contains a preservative (e.g. pyridostigmine oral solution), then the BUD is 35 days in controlled room temperature or refrigerated or shorter if indicated in the manufacturer’s labeling. The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription.

The North Dakota Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The State of Ohio Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

A pharmacy engaged in the following shall not be required to comply with the provisions of this chapter:

  1. The preparation of non-hazardous, conventionally manufactured non-sterile products in accordance with the directions contained in the approved labeling provided by the product’s manufacturer. A pharmacist shall perform the final check of the product.
  2. The preparation of radiopharmaceuticals as defined in agency 4729 of the Administrative Code.
  3. Sterile compounded drug preparations in accordance with rule 4729:7-2-02 of the Administrative Code.
  4. The addition of a flavoring agent to a conventionally manufactured drug product.

The Oklahoma State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

HB 4010a

  • SECTION 2. The addition of flavoring to a drug intended for dispensation may not be considered compounding if the flavoring:
  • (1) Is inert, nonallergenic and has no effect other than imparting a flavor to the drug or modifying the flavor of the drug; and
  • (2) Does not constitute more than five percent of the total volume of the drug.

 

The Pennsylvania State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

The definition of “compounding” does not include the unencumbered flavoring of conventionally manufactured medications provided that the flavors used are inert, tested and do not alter a medication’s concentration beyond USP’s accepted level of variance.

The Puerto Rico Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Rhode Island Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The South Carolina Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Simple compounding that does not precipitate the application of this form include: 1) Reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer; 2) Making twenty or less compounds of an oral liquid or topical dosage form utilizing five or less non-hazardous APIs over any 30 day period (not exempt from 40-43-86(CC)(6), “Formulas and Logs Maintained”).

The South Dakota State Board of Pharmacy does not regulate flavoring as compounding.

The following guidance is in place:

USP <795>; USP <797>; USP <800>: Tyler Laetsch, Pharm.D., Pharmacy Inspector

  • USP 795 and USP 797 published June 1, 2019 for go live date of December 1, 2019.

  • USP 795 clarifications – Flavoring antibiotic suspensions is not compounding, simple reconstitution of antibiotics with water is not compounding; however, combining two creams or preparing a magic mouthwash is compounding and USP 795 must be followed including the restriction for carpet in the compounding area (Board may propose to allow extra time for compliance) and the BUD changes

The Tennessee Board of Pharmacy does not regulate flavoring as compounding.

The following language has been approved and is currently undergoing rules promulgation:

(2) Solely adding flavoring to medications is not considered compounding. (3) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5. Authority: T.C.A. §§ 63-10-216, 63-10-304, and 63-10-30.

The Texas State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

(H) A pharmacist may add flavoring to a prescription at the request of a patient, the patient’s agent, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented. Documentation of beyond-use-dates longer than fourteen days shall be maintained by the pharmacy electronically or manually and made available to agents of the board on request. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient’s agent unless the pharmacist obtains a prescription for the over-the-counter product from the patient’s practitioner.

The Utah Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Flavoring Rule Utah Admin Code R156-17b-102

(13) “Compounding,” as defined in Subsection 58-17b-102(18), in accordance with 21 U.S.C. 353a(e) Pharmacy Compounding, does not include:

(a) mixing, reconstituting, or other such acts that are performed in accordance with directions in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling; or

(b) the addition of flavoring agents to conventionally manufactured and commercially prepared available liquid medications, if the flavoring agents:

  1. are therapeutically inert; and
  2. do not exceed 5% of a preparation’s total volume.

The Vermont Board of Pharmacy does not regulate flavoring as compounding.

The following language has been approved and is currently undergoing rules promulgation:

Addition of flavoring agents to conventionally manufactured products is not considered compounding; provided that the flavoring agent is inert and does not alter the product’s concentration beyond USP’s accepted level of variance, and that the pharmacy labels the product with an expiration date and storage instructions consistent with any effect on stability caused by the addition of flavoring. The addition of flavoring must be documented as part of the prescription record, reconstitution log, or other similar documentation. The documentation shall include the agent’s flavor, manufacturer, lot number, and expiration date.

While the Virginia Board of Pharmacy is statutorily bound to adopt USP standards for compounding, they currently exercise enforcement discretion when it comes to the practice of flavoring medicines.

The Washington State Pharmacy Quality Assurance Commission regulates flavoring as compounding to USP 795 standards.

The West Virginia Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

2.1.7.c. The following are not “compounding” and are exempt from USP 795 Compounding Standards:

2.1.7.c.1. the reconstitution of a drug pursuant to a manufacturer’s directions;

2.1.7.c.2. the act of tablet splitting, crushing, or capsule opening, including those hazardous medications listed in NIOSH List Tables 2 and 3;

2.1.7.c.3. upon the request of the prescribing practitioner and/or the patient for whom the prescription is ordered or such patient’s agent, the addition of therapeutically inert, nonallergenic flavoring agents to a commercially manufactured product, not in excess of five percent (5%) of the preparation’s total volume;

The Wisconsin Pharmacy Examining Board does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Wyoming State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Compounding does not include mixing, reconstituting, adding flavoring or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with the labeling.

The Alaska Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Alabama State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Arkansas State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Arizona Board of Pharmacy does not regulate flavoring as compounding.

The following substantive policy is in place:

  1. A pharmacist may add flavoring agents, up to a maximum of five (5) percent (%) of the total volume, to a prescription at the request of a patient, the patient’s caregiver, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented and maintain electronic or manual documentation of the flavoring agent and quantity added. Documentation of beyond-use-dates longer than fourteen days, including the flavoring agent and quantity added, shall be maintained by the pharmacy electronically or manually and made available to agents of the Board on request.
  2. The addition of flavoring agents over five (5) percent (%) of the total volume to a prescription requires the permission of the prescriber and compliance with the requirements of the Current Good Compounding Practices rule (A.A.C. R4-23-410).

The California State Board of Pharmacy does not currently regulate flavoring as compounding.

The Board has the following rule in place:

Article 4.5 Compounding 1735. Compounding in Licensed Pharmacies (a) “Compounding” means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription: (1) Altering the dosage form or delivery system of a drug (2) Altering the strength of a drug (3) Combining components or active ingredients (4) Preparing a compounded drug preparation from chemicals or bulk drug substances (b) “Compounding” does not include reconstitution of a drug pursuant to a manufacturer’s direction(s), nor does it include the sole act of tablet splitting or crushing, capsule opening, or the addition of flavoring agent(s) to enhance palatability.

However, this language is set to be stricken and the Board of Pharmacy plans to regulate flavoring to USP 795 standards.

Click to learn more about California and flavoring

The Colorado State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

3.00.55 Prescription Flavoring. A flavor additive may be incorporated into a non-sterile prescription under the following conditions:

  1. The patient, patient’s caregiver, or practitioner who authorized the original prescription shall authorize the flavoring of each new and, if applicable, refilled prescription.
  2. The flavor additive shall in no way compromise the stability, safety, or efficacy of the dispensed drug.
  3. No expired flavor additive shall be incorporated into a prescription. No flavor additive shall be incorporated which will expire prior to utilization by the patient, based on the practitioner’s directions for use.
  4. For flavoring additives that do not have expiration dates assigned by the manufacturer or supplier, a pharmacist shall clearly and legibly label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt, to the flavoring additive. In no event shall the labeled date of receipt or assigned expiration date be later altered after originally labeling the container.
  5. The following information shall be recorded and maintained in a suitable hard-copy or electronic dispensing record for a period of two years from the date of flavoring the corresponding new or refilled prescription. This record shall be made available, in printed form, for the Board or its representatives immediately upon the request of the Board or its representatives. 1) Additive’s flavor; 2) Flavor additive’s manufacturer 3) Flavor additive’s lot number (if available); and 4) Flavor additive’s expiration date.
  6. The pharmacist responsible for conducting the final evaluation of a new or refilled prescription shall also be responsible for the flavoring of the prescription as specified in subsections a., b., and c. of this Rule 3.00.55.
  7. The pharmacist manager shall be responsible for subsection d. of this Rule 3.00.55 and the maintenance of records as specified in subsection e. of this Rule 3.00.55.

The Connecticut Commission of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Sec. 20-617a. Flavoring agent added to prescription product.

(a) For purposes of this section, “flavoring agent” means an additive used in food or drugs when such additive: (1) Is used in accordance with good manufacturing practice principles and in the minimum quantity required to produce its intended effect, (2) consists of one or more ingredients generally recognized as safe in food and drugs, has been previously sanctioned for use in food and drugs by the state or the federal government, meets United States Pharmacopeia standards or is an additive permitted for direct addition to food for human consumption pursuant to 21 CFR 172, (3) is inert and produces no effect other than the instillation or modification of flavor, and (4) is not greater than five per cent of the total weight of the product.

(b) A flavoring agent may be added to a prescription product by: (1) A pharmacist upon the request of the prescribing practitioner, patient for whom the prescription is ordered or such patient’s agent, or (2) a pharmacist acting on behalf of a hospital, as defined in section 19a-490.

(P.A. 12-12, S. 1.)

The District of Columbia Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Delaware State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Florida Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

While the Georgia Board of Pharmacy is statutorily bound to adopt USP standards for compounding, they currently exercise enforcement discretion when it comes to the practice of flavoring medicines.

The Hawaii State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Iowa Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Compounding does not include the use of a flavoring agent to flavor a drug pursuant to rule 657—20.13(124,126,155A), nor does it include mixing or reconstituting a drug according to the product’s manufacturer label.

“Flavoring agent” means a therapeutically inert, nonallergenic substance consisting of inactive ingredients that is added to a drug to improve the drug’s taste and palatability.

657—20.13(124,126,155A) Use of flavoring agents. A flavoring agent may be added to a drug at the discretion of the pharmacist or upon the request of the prescriber, the patient, or the patient’s agent. The pharmacist may add flavoring agents not to exceed 5 percent of the total volume of the drug to which the flavoring agents are added. The pharmacist shall label the flavored drug with a beyond-use date no greater than 14 days past the date the flavoring agent is added if the drug is required to be stored in a refrigerator. A different beyond-use date or alternate storage conditions may be indicated if such variation is supported by peer-reviewed medical literature. The pharmacist shall electronically or manually document that a flavoring agent was added to a drug, and such documentation shall be made available for inspection and copying upon the request of the board or an agent of the board.

The Idaho State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

  1. COMPOUNDING DRUG PREPARATIONS. Any compounding that is not permitted herein is considered manufacturing. (7-1-21)T 01. Application. This rule applies to any person, including any business entity, authorized to engage in the practice of non-sterile compounding, sterile compounding, and sterile prepackaging of drug products in or into Idaho, except these rules do not apply to: (7-1-21)T a. Compound positron emission tomography drugs; (7-1-21)T b. Radiopharmaceutics; (7-1-21)T c. The reconstitution of a non-sterile drug or a sterile drug for immediate administration; (7-1-21)T d. The addition of a flavoring agent to a drug product; and (7-1-21)T e. Product preparation of a non-sterile, non-hazardous drug according to the manufacturer’s FDA approved labeling. (7-1-21)T

The Illinois Board of Pharmacy does not regulate flavoring as compounding.

The following statute is in place:

(o) “Compounding” means the preparation and mixing of components, excluding flavorings, (1) as the result of a prescriber’s prescription drug order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice or (2) for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing.

The Indiana Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Kansas State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Kentucky Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

201 KAR 2:076. Compounding.

Section 2. (1) All non-sterile compounded preparations shall be compounded pursuant to United States Pharmacopeia (USP) 795, unless specified portions submitted by a pharmacist have been waived by the board. Notwithstanding any USP guidance to the contrary, the addition of flavoring to a drug shall not be considered non-sterile compounding, if the additive:

(a) Is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor; and (b) Is not greater than five (5) percent of the drug product’s total volume.

The Louisiana Board of Pharmacy does not regulate flavoring as compounding.

The following guidance in place:

Louisiana Board of Pharmacy Policies & Procedures

Title: Addition of Flavors to Medications- Policy No. I.A.31

Resolved, that the Board adopt an enforcement policy, such that the addition of nonallergenic and inert flavoring agents to commercially available liquid oral products resulting in a change in the final product volume of less than 5% shall not require a prescriber’s order or a full compounding log.

The Massachusetts State Board of Pharmacy regulates flavoring as compounding to USP 795 standards.

The Maryland Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Maine Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Michigan Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

(e) “Compounding” does not include any of the following: (i) Except as provided in section 17748c of the code, MCL 333.17748c, the compounding of a drug product that is essentially a copy of a commercially available product. (ii) The reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved labeling provided by the manufacturer of a commercially available product. (iii) The compounding of allergenic extracts or biologic products. (iv) Flavoring agents added to conventionally manufactured and commercially available liquid medications. Flavoring agents must be nonallergenic and inert, not exceeding 5% of a drug product’s total volume.

The Minnesota State Board of Pharmacy regulates flavoring as compounding.

The Missouri Board of Pharmacy does not regulate flavoring as compounding.

The following guidance is in place:

H.12 FLAVORING

Licensees may flavor a legend product unless the prescriber indicates otherwise. OTC products may only be flavored by prescription. Licensees should indicate that the product was flavored on the patient’s container and the added flavoring must be documented in the pharmacy’s prescription record (e.g., in a flavoring book or in the prescription record). As defined by the Board’s rules, flavoring does not constitute compounding. Licensees may not flavor a prescription dispensed by another pharmacy.

The Mississippi Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

C. For the purpose of this Article, the combining of commercially manufactured, ready to-use products shall be exempt from USP 795 compounding standards under the following conditions: i. No more than four (4) commercially manufactured ready-to-use products (that have not been manipulated) are used; ii. All products used are FDA approved; iii. Compounding is not done in anticipation of medication orders; iv. Must follow USP 795 beyond use dates (BUDs); v. A valid prescription shall serve as the compounding record; vi. The prescription label shall comply with the labeling requirements as set forth in Article XIV of these regulations and also include: (1) Name of Preparation; (2) Strength and concentration of each component; 2 (3) Beyond Use Date; (4) Special storage requirements, if applicable; and (5) Cautionary auxiliary labels, if applicable.

The Montana Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The North Carolina Board of Pharmacy does not regulate flavoring as compounding to USP 795 standards.

The following guidance is in place:

Adding flavoring to Conventionally Manufactured Products

Q. Is adding flavoring to a conventionally manufactured product considered compounding?

A. USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a pharmacy adds flavoring to a manufactured product it must take into account the manufacturer’s Beyond Use Date (BUD) and the effect on stability caused by adding flavoring. If a flavoring component is added to a manufactured product that does not contain a preservative (e.g.: reconstitution of amoxicillin oral suspension) the BUD is 14 days refrigerated or shorter if indicated in the manufacturer’s labeling. If a flavoring component is added to a manufactured product that contains a preservative (e.g. pyridostigmine oral solution), then the BUD is 35 days in controlled room temperature or refrigerated or shorter if indicated in the manufacturer’s labeling. The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription.

The North Dakota Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The Nebraska Department of Health and Human Services, Division of Public Health, Licensure Unit does not regulate flavoring as compounding.

The following rule is in place:

(4) Any authorized person splitting a scored tablet along scored lines or adding flavoring to a commercially available drug product is not engaged in compounding.

The New Hampshire Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

“Compounding” shall not include the reconstitution of powdered formulations before dispensing or the addition of flavoring. “Compounding” shall not include the simple addition of flavoring, nor shall it include the preparation of a single dose of a nonhazardous commercially available drug or licensed biologic for administration within 2 hours of preparation to an individual patient when done in accordance with the manufacturer’s approved labeling or instructions consistent with that labeling.

The New Jersey State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

c) A compounding record shall not be required for:

1) Mixing, reconstituting, or assembling a drug according to the product’s labeling or the manufacturer’s directions; and

2) Product flavoring.

It is unclear how the New Mexico State Pharmacy Quality Assurance Commission will treat flavoring of conventionally manufactured medications moving forward.

The Nevada State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The New York State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The State of Ohio Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

A pharmacy engaged in the following shall not be required to comply with the provisions of this chapter:

  1. The preparation of non-hazardous, conventionally manufactured non-sterile products in accordance with the directions contained in the approved labeling provided by the product’s manufacturer. A pharmacist shall perform the final check of the product.
  2. The preparation of radiopharmaceuticals as defined in agency 4729 of the Administrative Code.
  3. Sterile compounded drug preparations in accordance with rule 4729:7-2-02 of the Administrative Code.
  4. The addition of a flavoring agent to a conventionally manufactured drug product.

The Oklahoma State Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

HB 4010a

 

The Pennsylvania State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

The definition of “compounding” does not include the unencumbered flavoring of conventionally manufactured medications provided that the flavors used are inert, tested and do not alter a medication’s concentration beyond USP’s accepted level of variance.

The Rhode Island Board of Pharmacy does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The South Carolina Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Simple compounding that does not precipitate the application of this form include: 1) Reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer; 2) Making twenty or less compounds of an oral liquid or topical dosage form utilizing five or less non-hazardous APIs over any 30 day period (not exempt from 40-43-86(CC)(6), “Formulas and Logs Maintained”).

The South Dakota State Board of Pharmacy does not regulate flavoring as compounding.

The following guidance is in place:

USP <795>; USP <797>; USP <800>: Tyler Laetsch, Pharm.D., Pharmacy Inspector

The Tennessee Board of Pharmacy does not regulate flavoring as compounding.

The following language has been approved and is currently undergoing rules promulgation:

(2) Solely adding flavoring to medications is not considered compounding. (3) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5. Authority: T.C.A. §§ 63-10-216, 63-10-304, and 63-10-30.

The Texas State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

(H) A pharmacist may add flavoring to a prescription at the request of a patient, the patient’s agent, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented. Documentation of beyond-use-dates longer than fourteen days shall be maintained by the pharmacy electronically or manually and made available to agents of the board on request. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient’s agent unless the pharmacist obtains a prescription for the over-the-counter product from the patient’s practitioner.

The Utah Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Flavoring Rule Utah Admin Code R156-17b-102

(13) “Compounding,” as defined in Subsection 58-17b-102(18), in accordance with 21 U.S.C. 353a(e) Pharmacy Compounding, does not include:

(a) mixing, reconstituting, or other such acts that are performed in accordance with directions in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling; or

(b) the addition of flavoring agents to conventionally manufactured and commercially prepared available liquid medications, if the flavoring agents:

  1. are therapeutically inert; and
  2. do not exceed 5% of a preparation’s total volume.

While the Virginia Board of Pharmacy is statutorily bound to adopt USP standards for compounding, they currently exercise enforcement discretion when it comes to the practice of flavoring medicines.

The Vermont Board of Pharmacy does not regulate flavoring as compounding.

The following language has been approved and is currently undergoing rules promulgation:

Addition of flavoring agents to conventionally manufactured products is not considered compounding; provided that the flavoring agent is inert and does not alter the product’s concentration beyond USP’s accepted level of variance, and that the pharmacy labels the product with an expiration date and storage instructions consistent with any effect on stability caused by the addition of flavoring. The addition of flavoring must be documented as part of the prescription record, reconstitution log, or other similar documentation. The documentation shall include the agent’s flavor, manufacturer, lot number, and expiration date.

The Washington State Pharmacy Quality Assurance Commission regulates flavoring as compounding to USP 795 standards.

The Wisconsin Pharmacy Examining Board does not regulate flavoring as compounding. This is not written in rule, but rather an informal policy that has been in place for decades.

The West Virginia Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

2.1.7.c. The following are not “compounding” and are exempt from USP 795 Compounding Standards:

2.1.7.c.1. the reconstitution of a drug pursuant to a manufacturer’s directions;

2.1.7.c.2. the act of tablet splitting, crushing, or capsule opening, including those hazardous medications listed in NIOSH List Tables 2 and 3;

2.1.7.c.3. upon the request of the prescribing practitioner and/or the patient for whom the prescription is ordered or such patient’s agent, the addition of therapeutically inert, nonallergenic flavoring agents to a commercially manufactured product, not in excess of five percent (5%) of the preparation’s total volume;

The Wyoming State Board of Pharmacy does not regulate flavoring as compounding.

The following rule is in place:

Compounding does not include mixing, reconstituting, adding flavoring or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with the labeling.