Chapter 480-11 PHARMACEUTICAL COMPOUNDING

Rule 480-11-.01 Definitions

(1)	"Administer" or "administration" means the provision of a unit dose and/or doses of medication to an individual patient as a result of the order of an authorized practitioner of the healing arts.

(2)	"Barrier Isolator" means an isolator specifically designed for compounding pharmaceutical ingredients or preparations in an aseptic environment.

(3)	"Biological safety cabinet" means a ventilated cabinet for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward HEPA filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection.

(4)	"Board of Pharmacy" or "Board" means the Georgia State Board of Pharmacy.

(5)	"Class 100 Environment" or "ISO Class 5" means an atmospheric environment which contains fewer than 100 particles 0.5 microns or larger in diameter per cubic meter of air.

(6)

"Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or de vice as the result of a practitioner's prescription drug order or initiative based on the relationship between the practitioner, patient, and pharmacist in the course of professional practice or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

(7)	"Component" means any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.

(8)	"Cytotoxic" means a pharmaceutical that has the capability of killing living cells.

(9)	"Deliver" or "delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration.

(10)	"Device" means an instrument, apparatus, contrivance, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label,"Caution: federal or state law requires dispensing by or on the order of a physician" or "Rx Only."

(11)	"Dispense" or "dispensing" means the preparation and delivery of a drug or device to a patient, patient's caregiver, or patient's agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a patient.

(12)	"Distribute" means the delivery of a drug or device other than by administering or dispensing.

(13)

"Drug" means:

(a)	Articles recognized as drugs in any official compendium, or supplement thereto, designated from time to time by the Board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

(b)	Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

(c)	Articles, other than food, intended to affect the structure or any function of the body of humans or animals; and

(d)	Articles intended for use as a component of any articles specified in subparagraph (a), (b), or (c) of this paragraph but does not include devices.

(14)

Drug regimen review includes but is not limited to the following activities:

(a)

Evaluation of any prescription drug order and patient record for:

1.	Known allergies;

2.	Rational therapy-contraindications;

3.	Reasonable dose and route of administration; and

4.	Reasonable directions for use.

(b)	Evaluation of any prescription drug order and patient record for duplication of therapy;

(c)

Evaluation of any prescription drug order and patient record for the following interactions:

1.	Drug-drug;

2.	Drug-food;

3.	Drug-disease; and

4.	Adverse drug reactions.

(d)	Evaluation of any prescription drug order and patient record for proper utilization, including over utilization or under utilization, and optimum therapeutic outcomes.

(15)	"Enteral" means within or by way of the intestine.

(16)	"FDA" means the United States Food and Drug Administration.

(17)	"GDNA" means the Georgia Drugs and Narcotics Agency.

(18)

"Labeling" means the process of preparing and affixing a label to any drug container exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or rule.

(19)	"Nonprescription drug" means a drug which may be sold without a prescription drug order and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and/or the federal government.

(20)	"Parenteral" means an injectable sterile preparation of drugs for administration by any other means than through the gastrointestinal tract.

(21)	"Patient counseling" means the oral communication by the pharmacist of information, as defined in the law and the rules of the Board, to the patient, patient's caregiver, or patient's agent, in order to improve therapy by ensuring proper use of drugs and devices.

(22)	"Pharmaceutical" means a compound to be used as a medicinal drug.

(23)	"Pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy. This recognizes a pharmacist as a learned professional who is authorized to provide patient services and pharmacy care.

(24)

"Pharmacist in charge" means a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs and who is personally in full and actual charge of such pharmacy and personnel.

(25)

"Pharmacy" means any place licensed in accordance with the laws and rules of this state wherein the possessing, displaying, compounding, dispensing, or selling of drugs may be conducted, including any and all portions of the building or structure leased, used, or controlled by the licensee in the conduct of the business or profession licensed by the Board at the address for which the license was issued.

(26)

"Practitioner" or "practitioner of the healing arts" means a physician, dentist, podiatrist, or veterinarian and shall include any other person licensed under the laws of this state to use, mix, prepare, dispense, prescribe, and administer drugs in connection with medical treatment to the extent provided by the laws of this state.

(27)	"Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient.

(28)	"Prospective drug use review" means a review of the patient's drug therapy and prescription drug order, as defined in the law and the rules of the Board, prior to dispensing the drug as part of a drug regimen review.

(29)	"Sterile pharmaceutical" means any dosage form devoid of viable microorganisms, or any other contaminant including, but not limited to, parenterals, injectables, and ophthalmics.

(30)	"Sterile Preparations" are those as defined by USP 797.

(31)	"USP-NF" means the United States Pharmacopeia and National Formulary.

Rule 480-11-.02 Compounded Drug Preparations

(1)

Compounded drug preparations - Pharmacist/Patient/Prescriber Relationship.

(a)

Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order or in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug preparations that are not commercially available in the marketplace or commercially available in the place as outlined by the restrictions under 12(b). Dispensing of pharmaceutical products shall be consistent with the provisions of O.C.G.A. T. 16, Ch. 13 and T. 26, Ch. 4 relating to the issuance of prescriptions and the dispensing of drugs.

(b)

Pharmacists shall receive, store, or use pharmaceuticals that have been manufactured or repackaged in a FDA-registered facility. Pharmacists shall also receive, store, or use pharmaceuticals in compounding preparations that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment to procure alternatives.

(c)

Pharmacists may compound pharmaceuticals prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such preparations compounded at the pharmacy. Preparations compounded in anticipation of a valid prescription drug order shall be properly labeled to include the name of the compounded pharmaceutical, date of compounding, and beyond-use date.

(d)

The distribution of non-patient specific compounded preparations for office use by a practitioner, excluding veterinarians, is prohibited. This subsection shall not affect 503b outsourcing facilities ability to provide non-patient specific compounded preparations for office use by a practitioner. The distribution of compounded preparations, for office administration or emergency dispensing, to a veterinarian shall not exceed 5% of production of compounded preparation in a calendar year by that pharmacy. Amounts produced greater than 5% shall be considered manufacturing and will require separate licensure as a manufacturer.

1.	"Emergency Dispensing" shall mean no more than a 96 hour supply dispensed for an urgent condition to an animal patient by a licensed veterinarian with a valid veterinarian-client-patient relationship when timely access to a compounding pharmacy is not available.

(e)

Pharmacists must maintain a separate compounding log for each compounded preparation that includes the quantity and amount of each pharmaceutical that is compounded. Pharmacists shall label all compounded preparations that are dispensed pursuant to a prescription in accordance with the provisions of O.C.G.A. T. 16, Ch. 13 and O.C.G.A. T. 26, Chs. 3 and 4, and Board rules and regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.

(f)	All compounded preparations labeled in accordance with Board rules and regulations regarding pharmaceutical compounding shall be deemed to meet the labeling requirements of O.C.G.A. T. 16, Ch. 13, and T. 26, Chs. 3 and 4.

(2)

Compounded drug preparations - Pharmacist for Distribution to Veterinarian.

(a)

Only a pharmacy licensed or registered by the Board may distribute compounded preparations to veterinarians licensed in this state for administration or emergency dispensing to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate supervision.

(b)	A veterinarian shall make a request to the pharmacy for a compounded preparation in the same manner as ordering products from a wholesale pharmaceutical distributor or manufacturer and not by using a prescription drug order.

(c)	A pharmacy receiving an order from a veterinarian for a compounded preparation shall maintain such order with its compounding records as required in Rule 480-11-.08 and other rules and regulations of the Board.

(d)

Pharmacists shall label all compounded preparations distributed to veterinarian for administration or emergency dispensing to their patients with the following:

1.	"By purchase order, Not by prescription",

2.	"For Office Use Administration or Emergency Dispensing by a Veterinarian Only - Not for resale",

3.	The name of the active ingredients and strengths contained in the compounded preparation,

4.	The lot number or identification of the compounded preparation,

5.	The pharmacy's name, address and telephone number,

6.	The initials of the pharmacist verifying the finished compounded preparation and the date verified,

7.	The quantity, amount, size, or weight of the compounded preparation in the container,

8.	An appropriate beyond-use (expiration) date of the compounded preparation as determined by the pharmacist in compliance with Board rule and USP-NF standards for pharmacy compounding, and

9.	Appropriate ancillary instructions such as storage instructions or cautionary statements, and where appropriate, hazardous drug warning labels.

(e)

Pharmacists shall enter into a written agreement with a veterinarian for the veterinarian's use and emergency dispensing of the compounded preparation before providing any compounded preparation to the veterinarian. The written agreement shall provide the following information:

1.	The name and address of the veterinarian, license number and contact information.

2.	An agreement by the veterinarian that the compounded preparation may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except for a case in which emergency dispensing is required.

3.	An agreement by the veterinarian to include on the patient's chart, or medication administration record the lot number and beyond-use date of the compounded preparation administered or dispensed to the patient.

4.	The procedures for a patient to report an adverse reaction or to submit a complaint about a compounded preparation.

5.	The procedure to be used when the pharmacy has to recall a batch of compounded preparation.

(f)

When pharmacists are compounding preparations to be provided to veterinarians for use in patient care or when pharmacists are altering or repackaging such products for veterinarians to use in patient care in the veterinarian's office, the compounding shall be conducted as allowed by applicable federal law and Board rules and shall be in compliance with USP-NF standards for compounding.

(g)	Pharmacists may not compound Schedule II, III, IV or V controlled substances, as defined in Article 2 of Chapter 13 of Title 16 without a patient specific prescription drug order.

(h)

Nothing in this paragraph shall be construed to apply to pharmacies owned or operated by institutions or to pharmacists or practitioners employed by an institution or its affiliated entities; provided, however, pharmacies owned or operated by institutions and pharmacists and practitioners within or employed by institutions or affiliated entities shall remain subject to the other rules and regulations of the Board governing the compounding of pharmaceuticals.

(3)	Pharmacists must maintain documentation of proof that the beyond-use date on compounded pharmaceuticals is valid.

(4)

Pharmacists shall personally perform or personally supervise the compounding process, which shall include a final verification check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.

(5)	Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.

(6)

Pharmacists may use prescription bulk substances in compounding when such bulk substances:

(a)

Comply with the standards of an applicable USP-NF monograph, if such monograph exists, including the testing requirements, and the Board rules on pharmaceutical compounding; or are substances that are components of pharmaceuticals approved by the FDA for use in the United States; or otherwise approved by the FDA;

(b)	Are manufactured by an establishment that is registered by the FDA; and

(c)	Are distributed by a wholesale distributor licensed by the Board and registered by the FDA to distribute bulk substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.

(7)

Pharmacists shall maintain records of all compounded pharmaceutical products. Pharmacist shall maintain a complete compounding formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail when such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product.

(a)

This record-keeping requirement does not apply when FDA-approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.

(8)	Pharmacists engaged in the compounding of pharmaceuticals shall operate in conformance with Georgia laws and regulations. Non-sterile compounded preparations shall be subject to USP 795. All sterile compounded preparations shall be subject to USP 797.

(9)	Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board's rules for nuclear pharmacists and pharmacies must be followed.

(10)

Special precaution preparations. If drug preparations with special precautions for contamination are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its return to inventory, must be utilized in order to prevent cross-contamination.

(11)

Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved.

(a)	All cytotoxic drugs should be compounded in a vertical flow, Class II, biological safety cabinet or an appropriate barrier isolator. Other preparations should not be compounded in this cabinet.

(b)	Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH.) in addition to appropriate compounding attire as described in USP 797.

(c)	Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile preparations.

(d)	Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.

(e)	Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.

(f)	Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and delivered in a manner to minimize the risk of accidental rupture of the primary container.

(g)	Disposal of cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of cytotoxic and/or infectious waste in a manner so as not to endanger the public health.

(12)

Pharmacists shall not engage in the following:

(a)	The compounding for human use of a pharmaceutical product that has been withdrawn or removed from the market by the FDA because such drug product or a component of such drug product has been found to be unsafe.

(b)

The compounding of any pharmaceutical products that are essentially copies of commercially available pharmaceutical products. However, this prohibition shall not include:

1.	The compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual patient,

2.	The compounding of a commercially available manufactured pharmaceutical during times when the product is not available from the manufacturer or wholesale distributor,

3.	The compounding of a commercially manufactured pharmaceutical that appears on the drug shortages list, or

4.	The mixing of two or more commercially available products of which the end product is a commercially available product.

(13)	Practitioners who may lawfully compound pharmaceuticals for administering or dispensing to their own patients pursuant to O.C.G.A. Section 26-4-130 shall comply with all the provisions of this rule and other applicable Board laws, rules and regulations.

Rule 480-11-.03 Organization and Personnel

(1)

The pharmacist has the responsibility and authority to inspect and approve or reject all components, drug preparations containers, closures, in-process materials, and labeling; and the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for the proper maintenance, cleanliness, and use of all equipment used in prescription compounding practice.

(2)

Pharmacists who engage in drug compounding, and any other pharmacy personnel, supervised by pharmacists, who assist in drug compounding, shall be competent and proficient in compounding procedures and shall maintain that proficiency through current awareness and training and documentation of that training. Every pharmacist who engages in drug compounding and any other pharmacy staff member who assists in compounding, must be aware of and familiar with all details of these good compounding practices. Records of documentation of training for all personnel must be maintained for a minimum of five (5) years.

(3)

All pharmacy personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel, such as coats/jackets, aprons, gowns, hand or arm coverings, or masks shall be worn as necessary to protect personnel from chemical exposure and drug preparations from contamination.

(4)

Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation. Any person known at any time (either by medical examination or pharmacist determination) to have an apparent illness or open lesions that may adversely affect the safety or quality of a drug preparation being compounded shall be excluded from direct contact with components, drug preparation containers, closures, in-process materials, and drug preparations until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of the preparations being compounded. All personnel who assist the pharmacist in compounding procedures shall be instructed to report to the pharmacist any health conditions that may have an adverse effect on drug preparations.

Rule 480-11-.04 Facilities and Equipment

(1)

Facilities.

(a)

Pharmacies engaging in compounding shall have an adequate area for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile preparations shall be separate and distinct from the area used for the compounding of non-sterile drug preparations. The area(s) used for compounding of drugs shall be maintained in a good state of repair.

(b)	Bulk drugs and other chemicals or materials used in the compounding of prescription drug orders must be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.

(c)

Adequate lighting and ventilation shall be provided in all drug-compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute to contamination of any compounded drug preparation. Adequate washing facilities, easily accessible to the compounding area(s) of the pharmacy shall be provided. These facilities shall include, but not be limited to, hot and cold water, soap or detergent, and air dryers or single-use towels.

(d)	Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area(s) shall be disposed of in a safe and sanitary manner.

(2)

Equipment.

(a)

Equipment used in the compounding of drug preparation shall be of appropriate design, appropriate capacity, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug preparations shall be of suitable composition so that surfaces that contact components, in-process materials, or drug preparations shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug preparation beyond that desired.

(b)

Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug preparation beyond that desired. In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug preparations, cleaning, sterilization, and maintenance procedures as set forth in Board Rules.

(c)	Equipment and utensils used for compounding drugs must be stored in a manner to protect them from contamination. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.

(d)

Automatic, mechanical, electronic, or other types of equipment other than commercial scale manufacturing or testing equipment, may be used in the compounding of drug preparations. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.

(3)

Physical requirements for pharmacies compounding sterile parenteral preparations.

(a)

A pharmacy compounding or preparing sterile parenteral preparations shall have a designated area for preparing compounded, sterile parenteral preparations as defined in USP 797. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. It shall be used only for the preparation of sterile parental preparations.

(b)

Equipment and supplies for compounding sterile parenteral preparations. A pharmacy compounding sterile parenteral preparations shall have the following minimum equipment and supplies:

1.	Laminar airflow hood (ISO 5) located within a clean room, or barrier isolator as described in USP 797;

2.	Infusion pumps, if appropriate;

3.	Sink, in working condition, with hot and cold running water, which is convenient to the compounding area for the purpose of hand scrubs prior to compounding;

4.	Facility for light/dark field examination;

5.	Appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy agents;

6.	A Class II, vertical flow biological safety cabinet or appropriate barrier isolator, if chemotherapy agents are routinely prepared;

7.	Refrigerator/freezer in working condition;

8.	If compounding onsite using components which must be weighed, Class A Balance with an assortment of metric weights or a Class I or II Electronic Balance;

9.	Disposable needles, syringes and other supplies needed for aseptic admixture;

10.	Disinfectant cleaning solutions;

11.	Handwashing agent with bactericidal action;

12.	Disposable, lint free towels or an automatic hand dryer;

13.	Appropriate filters and filtration equipment;

14.	Disposable masks and sterile, disposable gloves, gowns, hair and shoe covers and goggles when indicated;

15.	An oncology drug spill kit, if chemotherapy agents are routinely prepared.

16.	For the purpose of emergency or immediate patient care, compounded sterile preparations are exempted from the requirements as outlined in USP 797.

(4)

Minimum equipment for pharmacies compounding non-sterile preparations.

(a)	A compounding pharmacy must have all equipment required of a pharmacy in Chapter 480-10 of the Board Rules.

(b)	Additionally, a compounding pharmacy must have the appropriate equipment for use in compounding as defined in USP Chapters 795 and 797.

(5)

References. In addition to references required of a pharmacy, pharmacies compounding sterile pharmaceuticals shall also have a current edition of or electronic access to an established reference on IV stability and incompatibility, such as, Handbook on Injectable Drugs or King's Guide to Parenteral Admixtures, current Federal requirements for sterile compounding and other reference material including but not limited to:

(a)	"USP Pharmacists Pharmacopeia",

(6)

Variances.

(a)

The pharmacist-in-charge may submit to the Georgia State Board of Pharmacy a typed request for a variance to the provisions relating to minimum equipment requirements. The reasons for the request for a variance must be included in the submitted request. A variance shall be granted by the Board only when, in the judgment of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requestor will be notified of the Board's decision in writing.

(b)	If approved, said letter(s) will serve as proof of the Board's approval for the variance indicated in the letter, and must be posted next to the inspection report.

Rule 480-11-.05 Drug Compounding Controls

(1)

For compounding of drugs in anticipation of prescription drug orders:

(a)

There shall be written procedures for the compounding of drug preparations to assure that the finished preparations have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include a listing of the components (ingredients), their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. All equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug, shall be listed. These written procedures shall be followed in the execution of the drug compounding procedure. Nothing in these rules shall prohibit or exclude the use of electronic or computer equipment to meet these requirements.

(b)

Components for drug preparation compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures. If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed/stored in an appropriate container), the new container shall be appropriate and shall be identified with the:

1.	Component name; and

2.	Weight or measure.

(c)

To assure the reasonable uniformity and integrity of compounded drug preparations, written procedures shall be established and followed that describe the tests or examinations to be conducted on the preparation compounded (e.g., degree of weight variation among capsules.) Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug preparation. Such control procedures shall include, but are not limited to, the following (where appropriate):

1.	Capsule weight variation;

2.	Adequacy of mixing to assure uniformity and homogeneity;

3.	Clarity, completeness, or pH of solutions.

(d)	Appropriate written procedures designed to prevent microbiological contamination of compounded drug preparations purporting to be sterile shall be established and followed. Such procedures shall include validation of any sterilization process.

(e)

All personnel involved in any step of the compounding process shall be clearly identified in the compounding record. The compounding record must document the following:

1.	The ingredients and amounts or volumes used including the source, lot numbers and expiration dates;

2.	The order of the mixing or preparation of the preparation including the date mixed;

3.	The identity of the pharmacist and any staff member involved in each step of the procedure; and

4.	The pharmacy's lot or identification number and expiration date for the compounded drug/ preparation if applicable.

(2)

Compounding of drugs for an individual prescription drug order. The pharmacist must document in a readily retrievable manner, the following information:

(a)	The ingredients and lot numbers used in the compounding;

(b)	The amounts (weights or volumes) of each ingredient;

(c)	The order of component mixing;

(d)	A description of the compounding process;

(e)	The name of the responsible pharmacist and all other personnel involved in each step of the compounding; and

(f)	Appropriate written procedures designed to prevent microbiological contamination if the compounded prescription is purported to be sterile.

Rule 480-11-.06 Labeling and Control of Excess Preparations

In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients (components), the preparation date, and the assigned beyond-use date based upon the pharmacist's professional judgment, appropriate testing, or published data. It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics (e.g., in a clean, dry place on a shelf or in the refrigerator) to ensure its strength, quality, and purity as outlined in Rule 480-11-.07.

Rule 480-11-.07 Control of Components and Drug Preparation Containers and Closures

(1)

Components, drug preparation containers, closures, and bagged or boxed components of drug preparation containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area (e.g., floors) and inspection.

(2)

Drug preparation containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result. Components, drug preparation containers, and closures for use in the compounding of drug preparations shall be rotated so that the oldest stock is used first. Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug preparation. Drug preparation containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

(3)

Drug preparation containers and closures intended for the compounding of sterile preparations must be handled, sterilized, processed and stored to remove pyrogenic properties to assure that they are suitable for their intended purpose. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug preparation containers and closures used in the preparation of sterile pharmaceuticals. These processes shall be performed by pharmacists or under the pharmacist's supervision.

Rule 480-11-.08 Records and Reports

(1)	Any procedures or other records required to be maintained in compliance with this chapter shall be retained for the same period of time as required in chapter 480-10 of the Board Rules for the retention of prescription files.

(2)

All records required to be retained under this chapter or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection.

(3)

Records required under this chapter may be retained either as the original records or as true copies, such as photocopies, microfilm, microfiche, electronic files or other accurate reproductions of the original records. All records or reports must be producible immediately if requested by the Board or an agent of the GDNA or within forty-eight (48) hours if maintained in a central database.

(4)

In addition to standard record and reporting requirements, the following records and reports must be maintained for sterile pharmaceuticals:

(a)	A policy and procedure manual, including policies and procedures for cytotoxic and/or infectious waste, if applicable; and

(b)	Lot numbers and expiration dates of all the components used in compounding sterile prescription drug orders.

(c)

This record-keeping requirement does not apply when FDA approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.

Rule 480-11-.09 Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals

(1)

There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and facilities. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.

(a)

All clean rooms, ante rooms, barrier isolators and laminar flow hoods shall be certified following procedures such as those outlined in the CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2005) should be performed by a qualified individual no less than every six months whenever the device or room is relocated, altered, or major service to the facility is performed. Appropriate documentation and records shall be maintained.

(b)	There shall be written procedures developed requiring sampling if microbial contamination is suspected.

(c)	If bulk compounding of parenteral solutions is performed using non-sterile chemicals, extensive end preparation testing must be documented prior to the release of the preparation from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.

(d)	There shall be documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits.

Rule 480-11-.10 Exceptions

The requirements of this chapter do no 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.

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