RULE 070.00.01-001 - 07-02-0002 - Good Compounding Practices
RULE 070.00.01-001. 07-02-0002 - Good Compounding Practices
A. This regulation describes the requirements of minimum current good compounding practice for the preparation of drug products by pharmacies or other facilities with permits issued by the Arkansas State Board of Pharmacy.
The following words or terms, when used in this regulation, shall have the following meaning, unless the context clearly indicates otherwise:
1. Compounding: means the preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a duly authorized practitioner's prescription drug order or initiative based on the Practitioner/Patient/Pharmacist relationship in the course of professional practice.
a. Compounding may also be for the purpose of, or as an incident to, research, teaching, or chemical analysis.
b. Compounding includes the preparation of Drugs or Devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
c. Reconstitution of commercial products is not considered compounding for the purposes of this regulation.
2. Component: means any ingredient used in the compounding of a drug product, including those that may not appear in such product.
3. Manufacturing: means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of the substance(s) or labeling or re-labeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes any preparation of a drug or device that is given or sold for resale by pharmacies, practitioners, or other persons. The distribution of inordinate amounts of compounded products, without a practitioner/patient/pharmacist relationship is considered manufacturing.
4. Pharmacy Generated Products (PGP: means a medical product that is prepared, packaged, and labeled in a pharmacy that can be sold by the pharmacy without a prescription.
C. Pharmacist Responsibilities:
1. All pharmacists, who engage in drug compounding, shall be proficient in compounding and shall continually expand their compounding knowledge by participating in seminars and/or studying appropriate literature.
2. Every pharmacist engaging in drug compounding must be familiar with all details of Good Compounding Practices and should be familiar with FDAMA related patient regulation.
3. The pharmacist has the responsibility to:
a. Assure the validity of all prescriptions;
b. approve or reject all components, drug product containers, closures, in-process materials, and labeling;
c. prepare and review all compounding records and proceduresto assure that no errors have occurred in the compounding process;
d. assure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice;
e. assure only personnel authorized by the pharmacist in charge shall be in the immediate vicinity of the drug compounding operation.
D. Drug Compounding Facilities:
1. Pharmacies engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions, including the placement or equipment and materials.
2. The aseptic processing for sterile products shall be in an area separate and distinct from the area used for the compounding of non-sterile drug products.
3. The area(s) used for the compounding of drugs shall be maintained in a good state of repair.
4. Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.
5. Adequate lighting and ventilation shall be provided in all compounding areas.
6. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product.
7. These area(s) used for compounding shall be maintained in a clean and sanitary condition.
8. If parenteral products are being compounded, standards set out in Board Regulation 07-02-0001 must be met.
E. Compounding Equipment
1. Equipment used in the compounding of drug products shall be of appropriate design and capacity as well as suitably located to facilitate operations for its intended use, cleaning, and maintenance.
2. Compounding equipment shall be of suitable composition so the surfaces that contact components shall not be reactive, additive, or absorptive so as to alter the purity of the product compounded.
3. Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination.
4. Equipment and utensils must be stored in a manner to protect from contamination.
5. Automated, mechanical, electronic, limited commercial scale manufacturing or testing equipment, and other types of equipment may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.
6. Immediately prior to the initiation of compounding operations, the equipment and utensils must be inspected by the pharmacist and determined to be suitable for use.
7. When drug products with special precautions (antibiotics, hazardous materials and cytotoxins) are involved, appropriate measures must be utilized in order to prevent cross-contamination and proper disposal procedures must be followed. These measures include either the dedication of equipment for such operations or the meticulous cleaning of equipment prior to its use for the preparation of other drugs.
F. Component Selection Requirements:
1. Pharmacists shall first attempt to use USP-NF drug substances for compounding that have been made in an FDA inspected facility.
2. If components are not obtainable from a FDA-inspected facility of if the FDA and/or the company cannot document FDA inspection, pharmacists compounding prescriptions shall use their professional judgement in first receiving, storing, or using drug components that meet official compendia requirements or another high quality source.
G. Control of Drug Products:
1. Drug product containers and closures shall be handled and stored in a manner to prevent contamination and to permit inspection and cleaning of the work area.
2. Containers and closures shall be suitable material as to not alter the compounded drug as to quality, strength, or purity.
H. Drug Compounding Controls:
1. There shall be written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality and purity they purport or are represented to possess.
2. Procedures shall include a listing of the components, their amounts (in weight or volume), the order of component mixing, and a description of the compounding process.
3. 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.
4. All written procedures shall be followed in the execution of the compounding procedure.
5. Components 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 and measure is correct as stated in the written compounding procedures.
6. Written procedures shall be established and followed that describe the tests or examination to be conducted on the product compounded (e.g. degree of weight variation among capsules) to assure reasonable uniformity and integrity of compounded drug products.
a. 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 product.
b. Such control procedures shall include, but are not limited to, the following (where appropriate):
i. capsule weight variation;
ii. adequacy of mixing to assure uniformity and homogeneity; and
iii. clarity, completeness or pH of solutions.
7. Appropriate written procedures designed to prevent microbiological contamination of compounded drug products purporting to be sterile shall be established and followed. Such procedures shall follow accepted standards of practice and/or include validation of any sterilization process.
8. Beyond use dates and storage requirements (e.g. refrigeration) should be established. The USP-NF guidelines should be used.
1. If a component is transferred from the original container to another (e.g. a powder is taken from the original container, weighed, placed in a container) and stored in another container) the new container shall be identified with the:
a. component name;
b. lot and expiration date if available;
c. strength and concentration; and
d. weight or measure.
e. Route of administration
2. Products prepared in anticipation of a prescription prior to receiving a valid prescription should not be an inordinate amount.
a. A regularly used amount should be prepared based on a history of prescriptions filled by the pharmacy.
b. These products shall be labeled or documentation referenced with the:
i. complete list of ingredients or preparation name and reference;
ii. federal expiration date-up to one (1) year;
iii. assigned beyond -use date:
(a) based on published data, or;
(b) appropriate testing, or;
(c) USP-NF standards.
iv. storage under conditions dictated by its composition and stability (e.g., in a clean, dry place or in the refrigerator); and
v. batch or lot number.
3. Upon the completion of the drug preparation operation, the pharmacist shall examine the product for correct labeling.
4. The prescription label shall contain the following:
a. patient name;
b. prescriber's name;
c. name and address of pharmacy;
d. directions for use;
e. date filled;
f. beyond use date and storage (may be auxiliary labels); and
g. an appropriate designation that this is a compounded prescription, with reference to active ingredients.
J. Records and Reports:
1. Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records.
2. All records required to be retained under good compounding practices, or copies of such records, shall be readily available for authorized inspection.
3. Computer information and the hard copy of the prescription should indicate that the prescription is to be compounded.
4. Adequate records must be kept of controlled substances (Scheduled drugs) used in compounding.
K. Pharmacy Generated Product Requirements:
1. A Pharmacy Generated Product (PGP) may be prepared from legend drugs, not to exceed recommended strengths and doses.
2. PGP will be labeled properly and will be sold with the public's health and welfare in mind.
3. A PGP cannot be bulk compounded to sell to a second entity for resale. This would require a manufacturer's permit.
L. Compounding for a Prescriber's Office Use:
1. Pharmacies may prepare compounded drug products for a duly authorized prescriber's office use.
2. An order by the duly authorized prescriber, indicating the formula and quantity ordered, will be filed in the pharmacy.
3. The product is to be administered in the office and not dispensed to the patient. The product shall be labeled "For Office Use Only-Not for Resale".
4. A record of the compounded drug product may be kept as a prescription record in the pharmacy computer.
5. A label may be generated and a number assigned by the pharmacy computer for the compounded drug product.
6. Patient specific prescriptions for controlled substances cannot be filled "for office or medical bag use".
7. A retail pharmacy is not precluded from making more that five percent (5%) of its annual sales to licensed practitioners. The pharmacy must, however, obtain a State Wholesale Legend Drug and/or Controlled Substance Distributor Permit.
M. Compounding Veterinarian Products:
1. Prescriptions for animals may be compounded based on an order or prescription from a duly authorized prescriber.
2. These prescriptions are to be handled and filled the same as the human prescriptions.
3. Caution should be taken as to not violate federal patent laws by duplicating an available product in inordinate quantities.
4. Patient specific prescriptions for controlled substances cannot be filled "for office or medical bag use".(3/2/2001)
The following state regulations pages link to this page.