Non-sterile Compounding Flashcards
A pharmacist may compound non-sterile preparations in a quantity that is supported by prior
valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided:
the pharmacist can document a history of valid prescriptions subsequently received shortly thereafter or medication orders that have been generated solely
within an established professional prescriber-patient-pharmacist relationship, and provided the
prescription or medication order is retained on file at the pharmacy, consistent with the requirements of N.J.A.C. 13:39-7.19. The pharmacist shall document the batch preparation process in accordance with the requirements of N.J.A.C. 13:39-11A.15.
A pharmacist may prepare a pharmacy generated product to be sold OTC without a prescription or medication order provided that:
1) The product does not contain an ingredient that exceeds allowable strengths and doses for OTC drugs; and
2) The finished product is not one for which a prescription or medication order is required.
A finished product that is prepared pursuant to (a) above shall be properly labeled with the following:
1) The product name;
2) The name of all ingredients;
3) The strength or quantity of all active ingredients;
4) The package size;
5) Directions for use;
6) The use by date, consistent with the requirements of N.J.A.C 13:39-11A.11;
7) The name, address, and telephone number of the pharmacy;
8) Any ancillary and cautionary instructions, as needed; and
9) As pertinent, the requirements for proper storage.
A pharmacy generated product shall be:
sold directly to the consumer only after professional interaction or consultation between a pharmacist and the consumer.
A pharmacy generated product shall be:
stored in such a manner as to be inaccessible to
the public.
A pharmacy generated product shall not:
be sold to any entity for resale purposes.
The preparation of pharmacy generated products shall be:
documented in accordance with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14
A pharmacy that regularly engages in compounding shall:
have an area specifically designated for the safe and orderly compounding of drug products. Such area shall allow for the orderly placement of equipment and materials in order to minimize the potential for errors.
A pharmacy that engages in occasional compounding shall:
prepare an area prior to each compounding activity that allows for the safe and orderly compounding of drug products. The area shall allow for the orderly placement of equipment and materials in order to
minimize the potential for errors.
A pharmacy engaged in compounding shall ensure that:
1) All compounding areas are well-lighted and ventilated and are maintained in a clean
and sanitary condition;
2) Heating and air conditioning systems are controlled to avoid decomposition of chemicals;
3) Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area are maintained, and disposed of, in a timely, safe, and sanitary manner; and
4) The compounding area is easily accessible to hot and cold running water, exclusive of the bathroom sink; soap or detergent; and air dryers or single source towels.
A pharmacy shall:
possess equipment appropriate to the type of compounding performed at the pharmacy.
Equipment used in compounding drug products shall be:
of appropriate design and capacity, and shall be suitably located to facilitate operations for the intended use, cleaning, and maintenance of the equipment.
Equipment used in compounding drug products shall be:
of suitable composition. Equipment surfaces that contact components shall not be reactive, additive, or
adsorptive, so as to alter the safety, identity, strength, quality, and purity of the compounded product.
Equipment used in compounding drug products shall be:
thoroughly cleaned and sanitized after each use, and when necessary, prior to use, in order to prevent cross-contamination of ingredients and preparations.
Equipment used in compounding drug products shall be:
stored in a manner to prevent cross-contamination of ingredients and preparations.
Automated, mechanical, or electronic equipment may be:
used in compounding nonsterile preparations. All equipment utilized in compounding non-sterile preparations shall be inspected, maintained, and validated at appropriate intervals, consistent with
manufacturer’s recommendations, to ensure the accuracy and reliability of equipment performance.
A compounding pharmacist shall be responsible for ensuring that:
1) Compounded non-sterile preparations have been properly prepared, labeled,
controlled, stored, dispensed, and distributed in accordance with the provisions of
this subchapter;
2) All aspects of the compounding process set out in N.J.A.C. 13:39-11A.15 are
documented and that accurate compounding records for all compounded non-sterile
preparations prepared by the pharmacy are maintained;
3) Compounding personnel are capable of performing and qualified to perform their
assigned duties;
4) Ingredients used in compounding have their expected identity, quality, and purity
consistent with the requirements of N.J.A.C. 13:39-11A.12;
5) Compounded preparations are of acceptable strength, quality, and purity, with
appropriate packaging and labeling, and are prepared in accordance with good
compounding practices, official standards, and relevant scientific data and
information as set forth in USP 795, which is incorporated herein by reference, as
amended and supplemented, and which is available for purchase at the United States
Pharmacopeia website, www.usp.org;
6) Critical processes are recorded and validated to ensure that procedures will
consistently result in the expected qualities in the finished preparation;
7) The compounding environment is suitable for its intended purpose;
8) Appropriate stability evaluation is performed or is determined from the literature for
establishing reliable beyond-use dating to ensure that the finished preparations have
their expected potency, purity, quality, and characteristics, at least until the labeled
beyond-use date;
9) Compounding conditions and procedures are in place to minimize the potential for
errors;
10) Adequate procedures and records exist for investigating and correcting failures or
problems in compounding, testing, or in the preparation itself; and
11) The patient is advised that the product dispensed is a compounded preparation.
12) Any confirmed incidents of product contamination shall be reported by the PIC to the NJ Board of Pharmacy within 48 hours of becoming aware of any
such incidents.
The BUD is the date after which a compounded non-sterile preparation shall:
not be used. The BUD shall be determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, BUD may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
In the absence of stability information that is applicable to a specific drug product and
preparation, the following are the maximum beyond-use dates for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated:
For nonaqueous liquids and solid formulations:
i) Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of the time remaining until the
product’s expiration date or six months, whichever is earlier;
ii) Where a United States Pharmacopeia–National Formulary (USP–NF), analytical
reagent (AR), certified American Chemical Society (ACS), or Food Chemicals
Codex (FCC) grade substance is the source of the active ingredient, the BUD date shall not be later than 6 months or the expiration date of the
ingredient, whichever is earlier; and
iii) Where there is more than one ingredient, the beyond-use date shall be no longer than 6 months or the expiration date of the first ingredient to expire, whichever is earlier;
For water-containing formulations (prepared from ingredients in solid form), the BUD shall not be later:
than 14 days for liquid preparations when stored at
cold temperatures between two degrees and eight degrees Celsius (36 degrees and 46 degrees Fahrenheit)
For all other formulations, the beyond-use date shall not be later than:
the intended duration of therapy or 30 days, whichever is earlier.
The beyond-use date limits established in this section may be exceeded only when:
there is supporting valid scientific stability information that is directly applicable to the specific preparation (that is, the same drug concentration range, pH, excipients, vehicle, water content, etc.
All ingredients used to compound non-sterile preparations shall be:
United States Pharmacopeia–National Formulary (USP–NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade substance ingredient is not available, the pharmacist shall establish the purity and safety of the ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or reliability of source study.
A manufactured drug product may be utilized as the source of an active ingredient. Only manufactured drug products from containers labeled with a batch control number and an unexpired expiration date shall be…
utilized as sources of active ingredients. When
compounding with manufactured drug products, the compounding pharmacist shall consider all ingredients present in the drug product relative to the intended use of the compounded non-sterile preparation.
Components used in the compounding of non-sterile preparations such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as pharmacy stock. The preparation of such products shall be:
documented in accordance with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.
The dispensed container for any compounded non-sterile preparation shall bear a permanently affixed label with at least the following information:
1) In a retail pharmacy only, the name of the prescriber.
i) An institutional pharmacy compounding non-sterile preparations for out-patient use shall include the name of the prescriber on the label, consistent with the
labeling requirements for a retail pharmacy;
2) The name of the patient;
3) The name of all active ingredients;
4) Directions for use;
5) The use by date, consistent with the requirements of N.J.A.C 13:39-11A.11;
6) The name, address, and telephone number of the pharmacy;
7) Any ancillary and cautionary instructions as needed; and
8) As pertinent, the requirements for proper storage.
The compounding pharmacist shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing non-sterile preparation compounding. Supervision shall include, but is not limited to:
the checking of each ingredient used, the quantity of each ingredient whether weighed, measured, or counted, and the finished label
The compounding pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks:
recording of the prescription, selection of the drugs and container, typing of labels, and compounding of preparations. The compounding pharmacist shall ensure that each task has been performed correctly
Except as provided in (c) below, a pharmacy shall maintain a compounding record for each compounded non-sterile preparation that contains the following information:
1) Selection of the ingredients and documentation of source, lot numbers, and expiration dates of all ingredients used;
2) Verification that ingredients comply with the prescription or medication order;
3) Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11A.13;
4) Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies;
5) Strength of preparation;
6) Date of preparation;
7) Name or personal identifier of the person(s) who performed each step of the
compounding process and the compounding pharmacist(s) who verified the
preparation;
8) Reference(s) for formulation, if available;
9) Total quantity;
10) Detailed steps of the compounding process to ensure that the exact same compound
can be duplicated at a future date;
11) Type of dispensing container used when a drug has specific storage requirements;
12) Beyond-use date of the finished product consistent with the requirements in N.J.A.C.
13:39-11A.11;
13) The assigned internal identification number for the preparation or the prescription
number; and
14) Instructions for use, storage, and handling of the compounded preparation.
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.
