No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://drive.google.com/file/d/17QLcEuQm81OlPMBG5D5pmf-RIVkYjQZ-/view

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).
3. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient’s caregiver unless the pharmacist first obtains a prescription for the over-the-counter product from the patient’s medical practitioner.

https://www.pharmacy.ca.gov/laws_regs/lawbook.pdf

Note: Flavoring will be regulated as compounding with full adherence to USP 795 standards

“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.

https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=9470&fileName=3%20CCR%20719-1

3.00.55 Prescription Flavoring. A flavor additive may be incorporated into a non-sterile prescription under the following conditions: a. The patient, patient’s caregiver, or practitioner who authorized the original prescription shall authorize the flavoring of each new and, if applicable, refilled prescription. b. The flavor additive shall in no way compromise the stability, safety, or efficacy of the dispensed drug. c. 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. d. 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. e. 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. f. 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. g. 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.

https://www.cga.ct.gov/current/pub/chap_400j.htm#sec_20-617a

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

(c) The addition of a flavoring agent in accordance with subsections (a) and (b) of this section shall be exempt from the requirements established in subsections (a) to (m), inclusive, of section 20-633b, any regulations adopted pursuant to subsection (o) of section 20-633b and United States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – Nonsterile Preparations, and Chapter 800, Hazardous Drugs, as both may be amended from time to time.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://regulations.delaware.gov/register/june2024/proposed/27%20DE%20Reg%20955a%2006-01-24.htm

Pursuant to 24 Del.C. §2506(a)(1), the Delaware Board of Pharmacy (“Board”) has proposed revisions to its Rules and Regulations. First, the Board proposes to amend subsection 5.1.6, pertaining to compounding, to state that the definition of “compounding” does not include 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.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

See Notice of Intent to Adopt as Rule 480-11-.10. Exceptions

TEXT OF PROPOSED GEORGIA STATE BOARD OF PHARMACY RULE- RULE 480-11-.10 EXCEPTIONS

(1) The requirements of this chapter do not apply to the compounding or mixing of FDA­ approved drugs preparations pursuant to the manufacturer’s directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc.

(2) The act of adding flavoring agents to conventionally manufactured drug products, on its own, shall not be considered an act of pharmaceutical compounding.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://www.legis.iowa.gov/docs/iac/chapter/657.20.pdf

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

https://adminrules.idaho.gov/rules/current/24/243601.pdf

700. COMPOUNDING DRUG PREPARATIONS.
701. 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: (3-28-23)
702. The addition of a flavoring agent to a drug product; and (3-28-23)

https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24

(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.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://www.pharmacy.ks.gov/forms-faqs/faqs

• Is adding flavoring to a commercial oral liquid medication considered to be compounding?

At their February 22, 2024, meeting, the board confirmed their continued opinion that the addition of flavoring to a commercial oral liquid medication is not compounding if certain conditions are met.  Please note the board does not speak for other jurisdictions (FDA, other states, etc.) to which a facility may be subject.  The conditions that must be met include:

• The flavoring must not be reactive with the drug or any of its components.
• The addition must not change the concentration of the medication.
• A product that has been flavored cannot be returned to stock.
• An OTC medication cannot be flavored without a prescription.
• Any flavoring container that does not contain an expiration date must be assigned a 3-year expiration date upon opening.
• Addition of the flavoring must be documented in the prescription record and must include:
  • Flavor added (cherry, grape, etc.)
  • Quantity added

https://apps.legislature.ky.gov/law/kar/titles/201/002/076/

Section 9. Enforcement Discretion.

(2) The board shall not enforce the USP 795 standard that the addition of flavoring to a commercially available drug is compounding, if the additive:

(a) Is non-expired, 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.

https://www.pharmacy.la.gov/assets/docs/GuidanceDocuments/PPM_I.A.31_AdditionFlavorsMedications_2019-1113.pdf

Louisiana Board of Pharmacy Policies & Procedures

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

Following their review of the pharmacy law and rule, the Board determined a rule was not necessary and that an enforcement policy statement would be appropriate. The following motion was adopted after a unanimous vote in the affirmative.

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.

https://www.mass.gov/doc/2023-07-non-sterile-compounding-pdf/download

1. General
2. Patient-specific prescriptions are required to dispense any compounded preparation into, within, or from Massachusetts. Note: Flavoring may be added upon request of the patient or their agent for Schedule VI medications if it has not been requested by the prescriber. The prescription may be updated with this information in accordance with Policy 2018-01: Permitted Prescription Changes and Additions

III. Non-Sterile Compounding Process

1. Flavoring agent(s) added to conventionally manufactured non-sterile drug products is considered compounding. In addition to a policy and procedure, a pharmacy must ensure that the addition of the flavoring agent does not affect stability or alter the final concentration beyond the parameters outlined in USP . Available scientific data or studies, whether published or unpublished, may be utilized for this purpose.
2. Facility and Equipment
3. Pharmacies not engaged in complex non-sterile compounding must have a designated compounding area that should have at least 10 square feet of counter space that should not have carpeting. This area must be separated or otherwise protected from water sources (i.e., sink). Note: Flavoring agents may be added in a separate designated area (e.g., reconstitution area).
4. Labeling / BUDs
5. In addition to standard prescription labeling, a statement that the preparation is a non-sterile compounded drug preparation must also be included (MGL c. 94C § 21). If applicable, a statement that the product was flavored (e.g., auxiliary label, noted on label, etc.) must also be included on the patient’s container.
6. Documentation
7. In the case of pre-measured compounding kits and flavoring agents added to conventionally manufactured non-sterile drug products, the compounding record may also serve as the master formulation record and may be in the form of a log sheet. The following information must be documented and be readily retrievable: 1. date of preparation; 2. prescription number; 3. name, vendor / manufacturer / NDC, lot number, and expiration date of each component; 4. any relevant calculations and quantities/volumes of additives (e.g., water, flavoring agent(s), etc.); 5. BUD and any special storage requirements (e.g., refrigerate); and 6. identifier (e.g., name, initials, etc.) of individual who prepared the product (e.g., reconstitution, etc.).

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://ars.apps.lara.state.mi.us/AdminCode/DownloadAdminCodeFile?FileName=R%20338.471%20to%20R%20338.591.pdf&ReturnHTML=True

R 338.501  Definitions.

“Compounding” does not include any of the following:

(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.

https://mn.gov/boards/pharmacy/resourcesfaqs/faqs/compounding.jsp

Compounding

•  Is adding flavoring to a conventionally manufactured nonsterile product considered compounding?

Yes. United States Pharmacopeia (“USP”) has determined adding a component such as flavoring not stipulated in the labeling to a conventionally manufactured nonsterile product is compounding and has been within the scope of USP <795> since 2004. USP has reemphasized this in its November 1, 2022 guidance document entitled “<795>: Adding Flavor to Conventionally Manufactured Nonsterile Products.”

Additionally, Minnesota Rule 6800.3300, subpart 1 sets forth the standards for nonsterile compounding. The rule states that if pharmacies engage in nonsterile compounding, they must follow USP <795> standards.

The Minnesota Board of Pharmacy (“Board”) recognizes the importance of this service, particularly in the pediatric population. Furthermore, the Board is aware the majority of states, including those states who border with Minnesota and whose resident pharmacies may directly serve Minnesota patients, have either enacted rules or statutes creating exceptions for flavoring, or have indicated they may use enforcement discretion when applying USP <795> standards to its licensees who add flavoring.

Accordingly, at this time, if a licensed Minnesota pharmacy elects to add flavoring to a conventionally manufactured product for the purpose of improving palatability, the Board may exercise its enforcement discretion regarding the applicable USP <795> requirements with the exception of the following USP <795> requirements:

• • Flavoring agents must still consist of inactive ingredients and must not exceed 10% variance from the labeled strength.

• • If a pharmacy adds flavoring to a manufactured product it must still take into account the manufacturer’s Beyond Use Date (“BUD”) and the effect on stability caused by adding flavoring.

• • The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must still be documented in the patient record notes for the prescription. This includes any relevant calculations and quantities/volumes of additives (e.g., water, flavoring agent(s), etc.). Such documentation must still be made available for inspection and copying upon the request of the Board or an agent of the Board.

The Board also expects its licensees to follow and adhere to all other applicable state and federal rules and laws while conducting pharmacy operations.

https://pr.mo.gov/boards/pharmacy/practiceguide.pdf

(New Guide expected April 2025)

SECTION H: MEDICATION DISPENSING

H.14 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 Board is aware that USP is reviewing whether flavoring constitutes compounding. The Board has not adopted USP’s proposed revision at this time but may reconsider this approach in the future.

SECTION I: COMPOUNDING

As defined by the Board’s rules, compounding does not include incorporating a flavoring agent. However, licensees should indicate that the product was flavored on the patient container and the added flavoring must be documented in the prescription record. (See section H.14 for additional information on flavoring).

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://www.ncbop.org/faqs/general-pharmacy-faqs.html

Pharmacy Practice FAQs

Is adding flavoring to a conventionally manufactured product considered compounding?

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. When adding flavoring the compounding record must include the flavor manufacturer or product, lot number, and expiration date. All of this information about the flavoring must be documented in the patient record notes for the prescription.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://nebraskalegislature.gov/laws/statutes.php?statute=38-2867.01

(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.

https://gc.nh.gov/rsa/html/XXX/318/318-mrg.htm

“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.

https://www.njconsumeraffairs.gov/regulations/Chapter-39-State-Board-of-Pharmacy.pdf

c) A compounding record shall not be required for:

2) Product flavoring.

https://www.srca.nm.gov/parts/title16/16.019.0030.html

(4) the addition of a flavoring agent to a conventionally manufactured product is not considered compounding as long as the following conditions are met:

(a) the flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor;

(b) the flavoring agent does not alter a medication’s concentration beyond USP’s accepted level of variance;

(c) the addition of flavoring agent(s) is documented in the prescription record.

https://bop.nv.gov/uploadedFiles/bopnvgov/content/board/ALL/2024_Meetings/PublicHearingNoticeR053-24.pdf

Sec. 4.

1. A pharmacist, pharmaceutical technician or dispensing practitioner may add flavoring to an oral drug product at the request of a patient or a legal guardian of the patient, as applicable. A pharmacist, pharmaceutical technician or dispensing practitioner who adds flavoring to an oral drug product pursuant to this subsection shall:

(a) Make a record contemporaneous with the completion of the mixture, including, without limitation, the ingredients of the oral drug product;

(b) Ensure that the flavor additive does not compromise the stability, safety or efficacy of the dispensed oral drug product; and

(c) Assign the applicable beyond-use date to the oral drug product pursuant to chapter 795 of the United States Pharmacopeia – National Formulary, as adopted by reference in paragraph (b) of subsection 1 of NAC 639.670.

2. Except as otherwise provided in paragraph (c) of subsection 1, a pharmacist, pharmaceutical technician or dispensing practitioner is not required to comply with the compounding standards established in the publications and standards adopted by reference in subsection 1 of NAC 639.670 when he or she adds flavoring to an oral drug product pursuant to subsection 1 of this section.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://codes.ohio.gov/ohio-administrative-code/rule-4729:7-2-01

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

(4) The addition of a flavoring agent to a conventionally manufactured drug product.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://olis.oregonlegislature.gov/liz/2024R1/Downloads/MeasureDocument/HB4010/A-Engrossed

DRUGS

• SECTION 1. Section 2 of this 2024 Act is added to and made a part of ORS chapter 689.
• 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.

https://www.pshp.org/news/479128/Information-on-USP.htm

The following decisions were approved by the Board and placed on record:

1. The Board is enforcing USP 795 and 797 as currently written. Board Regulation Section 27.601 was finalized on June 22, 2019 and requires compliance with section 503a of the federal Food, Drug and Cosmetic Act, federal regulations promulgated thereunder and the current version of the USP chapters governing compounding.
2. The Board is delaying the enforcement of USP 800 until the appeals of certain provisions of the revised USP 795 and 797 are resolved. While enforcement of USP 800 is being delayed, pharmacies should do their best to comply with the requirements of USP 800, including the sections related to the handling of hazardous medications, as these requirements will be enforced at some time in the future, dependent on resolution of the appeals of the revised USP 795 and 797.
3. The Board voted to adopt the following position and will be amending its regulations to reflect this information:
   • 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.

No BOP rule/guidance in place. However, flavoring does not appear to be subject to USP 795 standards per enforcement discretion.

https://llr.sc.gov/bop/PFORMS/InspectionForms/Non-Sterile%20Compounding%20Pharmacy.pdf

Non-Sterile Compounding Inspection Form

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”).

https://publications.tnsosfiles.com/rules/1140/1140-07.20240314.pdf

1140-07-.09 NONSTERILE SIMPLE COMPOUNDING PREPARATIONS

(2) Solely adding flavoring to medications is not considered compounding.

https://adminrules.utah.gov/public/rule/R156-17b/Current%20Rules

(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:

(i) are therapeutically inert; and

(ii) do not exceed 5% of a preparation’s total volume.

https://www.dhp.virginia.gov/media/dhpweb/docs/pharmacy/guidance/110-36.pdf

8. Does USP consider flavoring to be compounding?

Yes, but the Board will exercise enforcement discretion of USP compounding standards for flavoring.

https://doh.wa.gov/sites/default/files/2024-02/690-318-GeneralSelfInspectionWorksheet.pdf

In Washington State, compounding is defined in RCW 18.64.011(6) and means “the act of combining two or more ingredients in the preparation of a prescription. Reconstitution and mixing of (a) sterile products according to federal food and drug administration approved labeling does not constitute compounding if prepared pursuant to a prescription and administered immediately or in accordance with package labeling, and (b) nonsterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription.”

Please note: If a pharmacy adds flavoring to a commercially available product, it is considered compounding and the non-sterile compounding self-inspection worksheets must also be completed.

https://apps.sos.wv.gov/adlaw/csr/readfile.aspx?DocId=57188&Format= PDF

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

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;

https://rules.wyo.gov/Search.aspx?Agency=059

See Pharmacy Board of (059)- Pharmacy Board of (0001)- General Practice of Pharmacy Regulations Chapter 2

Section 3

(iv)  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.

Section 13

(iii) No compounded or flavored prescription may be returned to stock;