Glass— Break the container or cut it with a circular saw fitted with a wet abrasive wheel, such as a carborundum or a bonded diamond wheel. Select sections to represent the average wall thickness in the case of blown glass containers, and trim them as necessary to give segments of a size convenient for mounting in the spectrophotometer. After cutting, wash and dry each specimen, taking care to avoid scratching the surfaces. If the specimen is too small to cover the opening in the specimen holder, mask the uncovered portion of the opening with opaque paper or masking tape, provided that the length of the specimen is greater than that of the slit in the spectrophotometer. Immediately before mounting in the specimen holder, wipe the specimen with lens tissue. Mount the specimen with the aid of a tacky wax, or by other convenient means, taking care to avoid leaving fingerprints or other marks on the surfaces through which light must pass.

Plastic— Cut circular sections from two or more areas of the container, and wash and dry them, taking care to avoid scratching the surfaces. Mount in the apparatus as described for Glass.

	Maximum Percentage of Light Transmission at Any Wavelength Between 290 and 450 nm
Nominal Size (in mL)	Flame-sealed Containers	Closure-sealed Containers
1	50	25
2	45	20
5	40	15
10	35	13
20	30	12
50	15	10

NOTE—Any container of a size intermediate to those listed above exhibits a transmission not greater than that of the next larger size container listed in the table. For containers larger than 50 mL, the limits for 50 mL apply.

The following tests are designed to determine the resistance to water attack of new (not previously used) glass containers. The degree of attack is determined by the amount of alkali released from the glass under the influence of the attacking medium under the conditions specified. This quantity of alkali is extremely small in the case of the more resistant glasses, thus calling for particular attention to all details of the tests and the use of apparatus of high quality and precision. The tests should be conducted in an area relatively free from fumes and excessive dust.

Type	General Description1	Type of Test	Limits
			Size,2 mL	mL of 0.020 N Acid
I	Highly resistant, borosilicate glass	Powdered Glass	All	1.0
II	Treated soda-lime glass	Water Attack	100 or less	0.7
			Over 100	0.2
III	Soda-lime glass	Powdered Glass	All	8.5
NP	General-purpose soda-lime glass	Powdered Glass	All	15.0
1  The description applies to containers of this type of glass usually available. 2  Size indicates the overflow capacity of the container.

Autoclave— For these tests, use an autoclave capable of maintaining a temperature of 121 ± 2.0, equipped with a thermometer, a pressure gauge, a vent cock, and a rack adequate to accommodate at least 12 test containers above the water level.

Mortar and Pestle— Use a hardened-steel mortar and pestle, made according to the specifications in the accompanying illustration.

Other Equipment— Also required are 20.3-cm (8-inch) sieves made of stainless steel including the Nos. 20, 40, and 50 sieves along with the pan and cover (see Sizes of Standard Sieve Series in Range of Interest under Particle Size Distribution Estimation by Analytical Sieving 786), 250-mL conical flasks made of resistant glass aged as specified, a 900-g (2-lb) hammer, a permanent magnet, a desiccator, and an adequate volumetric apparatus.

High-Purity Water— The water used in these tests has a conductivity at 25, as measured in an in-line cell just prior to dispensing, of not greater than 0.15 µS per cm (6.67 Megohm-cm). There must also be an assurance that this water is not contaminated by copper or its products (e.g., copper pipes, stills, or receivers). The water may be prepared by passing distilled water through a deionizer cartridge packed with a mixed bed of nuclear-grade resin, then through a cellulose ester membrane having openings not exceeding 0.45 µm.3 Do not use copper tubing. Flush the discharge lines before water is dispensed into test vessels. When the low conductivity specification can no longer be met, replace the deionizer cartridge.

Methyl Red Solution— Dissolve 24 mg of methyl red sodium in Purified Water to make 100 mL. If necessary, neutralize the solution with 0.02 N sodium hydroxide or acidify it with 0.02 N sulfuric acid so that the titration of 100 mL of High-Purity Water, containing 5 drops of indicator, does not require more than 0.020 mL of 0.020 N sodium hydroxide to effect the color change of the indicator, which should occur at a pH of 5.6.

Powdered Glass Test

Procedure— Transfer 10.00 g of the prepared specimen, accurately weighed, to a 250-mL conical flask that has been digested (aged) previously with High-Purity Water in a bath at 90 for at least 24 hours or at 121 for 1 hour. Add 50.0 mL of High-Purity Water to this flask and to one similarly prepared to provide a blank. Cap all flasks with borosilicate glass beakers that previously have been treated as described for the flasks and that are of such size that the bottoms of the beakers fit snugly down on the top rims of the containers. Place the containers in the autoclave, and close it securely, leaving the vent cock open. Heat until steam issues vigorously from the vent cock, and continue heating for 10 minutes. Close the vent cock, and adjust the temperature to 121, taking 19 to 23 minutes to reach the desired temperature. Hold the temperature at 121 ± 2.0 for 30 minutes, counting from the time this temperature is reached. Reduce the heat so that the autoclave cools and comes to atmospheric pressure in 38 to 46 minutes, being vented as necessary to prevent the formation of a vacuum. Cool the flask at once in running water, decant the water from the flask into a suitably cleansed vessel, and wash the residual powdered glass with four 15-mL portions of High-Purity Water, adding the decanted washings to the main portion. Add 5 drops of Methyl Red Solution, and titrate immediately with 0.020 N sulfuric acid. If the volume of titrating solution is expected to be less than 10 mL, use a microburet. Record the volume of 0.020 N sulfuric acid used to neutralize the extract from 10 g of the prepared specimen of glass, corrected for a blank. The volume does not exceed that indicated in Table 2 for the type of glass concerned.

Water Attack at 121

Procedure— Fill each container to 90% of its overflow capacity with High-Purity Water, and proceed as directed for Procedure under Powdered Glass Test, beginning with “Cap all flasks,” except that the time of autoclaving shall be 60 minutes instead of 30 minutes, and ending with “to prevent the formation of a vacuum.” Empty the contents from 1 or more containers into a 100-mL graduated cylinder, combining, in the case of smaller containers, the contents of several containers to obtain a volume of 100 mL. Place the pooled specimen in a 250-mL conical flask of resistant glass, add 5 drops of Methyl Red Solution, and titrate, while warm, with 0.020 N sulfuric acid. Complete the titration within 60 minutes after opening the autoclave. Record the volume of 0.020 N sulfuric acid used, corrected for a blank obtained by titrating 100 mL of High-Purity Water at the same temperature and with the same amount of indicator. The volume does not exceed that indicated in Table 2 for the type of glass concerned.

Arsenic

Arsenic 211— Use as the Test Preparation 35 mL of the water from one Type I glass container or, in the case of smaller containers, 35 mL of the combined contents of several Type I glass containers, prepared as directed for Procedure under Water Attack at 121: the limit is 0.1 µg per g.

Perform the in vitro biological tests according to the procedures set forth under Biological Reactivity Tests, In Vitro 87. Materials that meet the requirements of the in vitro tests are not required to undergo further testing. No plastic class designation is assigned to these materials. Materials that do not meet the requirements of the in vitro tests are not suitable for containers for drug products.

If a plastic class designation is needed for plastics and other polymers that meet the requirements under Biological Reactivity Tests, In Vitro 87, perform the appropriate in vivo tests specified for Classification of Plastics under Biological Reactivity Tests, In Vivo 88.

The following tests, designed to determine physical and chemical properties of plastics and their extracts, are based on the extraction of the plastic material, and it is essential that the designated amount of the plastic be used. Also, the specified surface area must be available for extraction at the designated temperature.

Preparation of Sample— From a homogeneous plastic specimen, use a portion, for each 20.0 mL of extracting medium, equivalent to 120 cm2 total surface area (both sides combined), and subdivide into strips approximately 3 mm in width and as near to 5 cm in length as is practical. Transfer the subdivided Sample to a glass-stoppered, 250-mL graduated cylinder of Type I glass, and add about 150 mL of Purified Water. Agitate for about 30 seconds, drain off and discard the liquid, and repeat with a second washing.

Blank— Use Purified Water where a blank is specified in the following tests.

Plastics for ophthalmics are composed of a mixture of homologous compounds, having a range of molecular weights. Such plastics frequently contain other substances such as residues from the polymerization process, plasticizers, stabilizers, antioxidants, pigments, and lubricants. Factors such as plastic composition, processing and cleaning procedures, contacting media, inks, adhesives, absorption, adsorption and permeability of preservatives, and conditions of storage may also affect the suitability of a plastic for a specific use.

The standards and tests provided in this section characterize high-density and low-density polyethylene containers that are interchangeably suitable for packaging dry oral dosage forms not meant for constitution into solution.

Where stability studies have been performed to establish the expiration date of a particular dry oral dosage form not meant for constitution into solution in a container meeting the requirements set forth herein for either high- or low-density polyethylene containers, then any other polyethylene container meeting the same sections of these requirements may be similarly used to package such dosage form, provided that the appropriate stability programs are expanded to include the alternative container, in order to assure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.

Both high- and low-density polyethylene are long-chain polymers synthesized under controlled conditions of heat and pressure, with the aid of catalysts from not less than 85.0% ethylene and not less than 95.0% total olefins. The other olefin ingredients most frequently used are butene, hexene, and propylene. The ingredients used to manufacture the polyethylene, and those used in the fabrication of the containers, conform to the requirements in the applicable sections of the Code of Federal Regulations, Title 21.

High-density polyethylene and low-density polyethylene both have an IR absorption spectrum that is distinctive for polyethylene, and each possesses characteristic thermal properties. High-density polyethylene has a density between 0.941 and 0.965 g per cm3. Low-density polyethylene has a density between 0.850 and 0.940 g per cm3. The permeation properties of molded polyethylene containers may be altered when re-ground polymer is incorporated, depending upon the proportion of re-ground material in the final product. Other properties that may affect the suitability of polyethylene used in containers for packaging drugs are: oxygen and moisture permeability, modulus of elasticity, melt index, environmental stress crack resistance, and degree of crystallinity after molding. The requirements in this section are to be met when dry oral dosage forms, not meant for constitution into solution, are intended to be packaged in a container defined by this section.

APPARATUS— Use an IR spectrophotometer capable of correcting for the blank spectrum and equipped with a multiple internal reflectance accessory and a KRS-5 internal reflection plate.4 A KRS-5 crystal 2 mm thick having an angle of incidence of 45 provides a sufficient number of reflections.

PREPARATION OF SPECIMEN— Cut 2 flat sections representative of the average wall thickness of the container, and trim them as necessary to obtain segments that are convenient for mounting in the multiple internal reflectance accessory. Taking care to avoid scratching the surfaces, wipe the specimens with dry paper or, if necessary, clean them with a soft cloth dampened with methanol, and permit them to dry. Securely mount the specimens on both sides of the KRS-5 internal reflection plate, ensuring adequate surface contact. Prior to mounting the specimens on the plate, they may be compressed to thin uniform films by exposing them to temperatures of about 177 under high pressures (15,000 psi or more).

PROCEDURE— Place the mounted specimen sections within the multiple internal reflectance accessory, and place the assembly in the specimen beam of the IR spectrophotometer. Adjust the specimen position and mirrors within the accessory to permit maximum light transmission of the unattenuated reference beam. (For a double-beam instrument, upon completing the adjustments in the accessory, attenuate the reference beam to permit full-scale deflection during the scanning of the specimen.) Determine the IR spectrum from 3500 to 600 cm–1: the corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of USP High-density Polyethylene RS or USP Low-density Polyethylene RS, similarly determined.

High-Density Polyethylene— The thermogram of the specimen is similar to the thermogram of USP High-Density Polyethylene RS, similarly determined, and the temperatures of the endotherms and exotherms in the thermogram of the specimen do not differ from those of the standard by more than 6.0.

Low-Density Polyethylene— The thermogram of the specimen is similar to the thermogram of USP Low-Density Polyethylene RS, similarly determined, and the temperatures of the endotherms and exotherms in the thermogram of the specimen do not differ from those of the standard by more than 8.0.

HEAVY METALS— Containers meet the requirements for Heavy Metals under Physicochemical Tests—Plastics.

NONVOLATILE RESIDUE— Proceed as directed for Nonvolatile Residue under Physicochemical Tests—Plastics, except that the blank shall be the same solvent used in each of the tests set forth below. The difference between the amounts obtained from the specimen and the blank does not exceed 12.0 mg when water maintained at a temperature of 70 is used as the extracting medium; does not exceed 75.0 mg when alcohol maintained at a temperature of 70 is used as the extracting medium; and does not exceed 100.0 mg for high-density polyethylene and does not exceed 350.0 mg for low-density polyethylene when hexanes maintained at a temperature of 50 are used as the extracting medium. Containers meet these requirements for Nonvolatile Residue for all of the above extracting media. [NOTE—Hexanes and alcohol are flammable. When evaporating these solvents, use a current of air with the water bath; when drying the residue, use an explosion-proof oven.]

The standards and tests provided in this section characterize polyethylene terephthalate (PET) and polyethylene terephthalate G (PETG) bottles that are interchangeably suitable for packaging liquid oral dosage forms.

Where stability studies have been performed to establish the expiration date of a particular liquid oral dosage form in a bottle meeting the requirements set forth herein for either PET or PETG bottles, any other PET or PETG bottle meeting these requirements may be similarly used to package such dosage form, provided that the appropriate stability programs are expanded to include the alternative bottle in order to assure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.

The suitability of a specific PET or PETG bottle for use in the dispensing of a particular pharmaceutical liquid oral dosage form must be established by appropriate testing.

PET resins are long-chain crystalline polymers prepared by the condensation of ethylene glycol with dimethyl terephthalate or terephthalic acid. PET copolymer resins are prepared in a similar way, except that they may also contain a small amount of either isophthalic acid (not more than 3 mole percent) or 1,4-cyclohexanedimethanol (not more than 5 mole percent). Polymerization is conducted under controlled conditions of heat and vacuum, with the aid of catalysts and stabilizers.

PET copolymer resins have physical and spectral properties similar to PET and for practical purposes are treated as PET. The tests and specifications provided in this section to characterize PET resins and bottles apply also to PET copolymer resins and to bottles fabricated from them.

PET and PET copolymer resins generally exhibit a large degree of order in their molecular structure. As a result, they exhibit characteristic composition-dependent thermal behavior, including a glass transition temperature of about 76 and a melting temperature of about 250. These resins have a distinctive IR absorption spectrum that allows them to be distinguished from other plastic materials (e.g., polycarbonate, polystyrene, polyethylene, and PETG resins). PET and PET copolymer resins have a density between 1.3 and 1.4 g per cm3 and a minimum intrinsic viscosity of 0.7 dL per g, which corresponds to a number average molecular weight of about 23,000 daltons.

PETG resins are high molecular weight polymers prepared by the condensation of ethylene glycol with dimethyl terephthalate or terephthalic acid and 15 to 34 mole percent of 1,4-cyclohexanedimethanol. PETG resins are clear, amorphous polymers, having a glass transition temperature of about 81 and no crystalline melting point, as determined by differential scanning calorimetry. PETG resins have a distinctive IR absorption spectrum that allows them to be distinguished from other plastic materials, including PET. PETG resins have a density of approximately 1.27 g per cm3 and a minimum instrinsic viscosity of 0.65 dL per g, which corresponds to a number average molecular weight of about 16,000 daltons.

PET and PETG resins, and other ingredients used in the fabrication of these bottles, conform to the requirements in the applicable sections of the Code of Federal Regulations, Title 21, regarding use in contact with food and alcoholic beverages. PET and PETG resins do not contain any plasticizers, processing aids, or antioxidants. Colorants, if used in the manufacture of PET and PETG bottles, do not migrate into the contained liquid.

APPARATUS— Use an IR spectrophotometer capable of correcting for the blank spectrum and equipped with a multiple internal reflectance accessory and a KRS-5 internal reflection plate.6 A KRS-5 crystal having a thickness of 2 mm and an angle of incidence of 45 provides a sufficient number of reflections.

PREPARATION OF SPECIMEN— Cut 2 flat sections representative of the average wall thickness of the bottle, and trim them as necessary to obtain segments that are convenient for mounting in the multiple internal reflectance accessory. Taking care to avoid scratching the surfaces, wipe the specimens with dry paper or, if necessary, clean them with a soft cloth dampened with methanol, and permit them to dry. Securely mount the specimens on both sides of the KRS-5 internal reflection plate, ensuring adequate surface contact.

PROCEDURE— Place the mounted specimen sections within the multiple internal reflectance accessory, and place the assembly in the specimen beam of the IR spectrophotometer. Adjust the specimen position and mirrors within the accessory to permit maximum light transmission of the unattenuated beams. (For a double-beam instrument, upon completing the adjustments in the accessory, attenuate the reference beam to permit full-scale deflection during the scanning of the specimen.) Determine the IR spectrum from 4000 to 400 cm1. The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of the USP Polyethylene Terephthalate RS, or the USP Polyethylene Terephthalate G RS, similarly determined.

Polyethylene Terephthalate— Heat the specimen from room temperature to 280 at a heating rate of about 20 per minute. Hold the specimen at 280 for 1 minute. Quickly cool the specimen to room temperature, and reheat it to 280 at a heating rate of about 5 per minute. The thermogram of the specimen is similar to the thermogram of USP Polyethylene Terephthalate RS, similarly determined: the melting point (Tm) of the specimen does not differ from that of the Standard by more than 9.0, and the glass transition temperature (Tg) of the specimen does not differ from that of the Standard by more than 4.0.

Polyethylene Terephthalate G— Heat the specimen from room temperature to 120 at a heating rate of about 20 per minute. Hold the specimen at 120 for 1 minute. Quickly cool the specimen to room temperature, and reheat it to 120 at a heating rate of about 10 per minute. The thermogram of the specimen is similar to the thermogram of USP Polyethylene Terephthalate G RS, similarly determined: the glass transition temperature (Tg) of the specimen does not differ from that of the Standard by more than 6.0.

EXTRACTING MEDIA—

PROCEDURE— [NOTE—Use the 50 Percent Alcohol Extracting Medium with PET bottles. Use the 25 Percent Alcohol Extracting Medium with PETG bottles.] For each Extracting Medium, fill a sufficient number of test bottles to 90% of their nominal capacity to obtain not less than 30 mL of extract. Fill a corresponding number of glass bottles with Purified Water Extracting Medium, a corresponding number of glass bottles with 50 Percent Alcohol Extracting Medium or 25 Percent Alcohol Extracting Medium, and a corresponding number of glass bottles with n-Heptane Extracting Medium for use as Extracting Media blanks. Fit the bottles with impervious seals, such as aluminum foil, and apply closures. Incubate the test bottles and the glass bottles in a constant temperature room or in an oven at 49 for ten days. Remove the test bottles with the Extracting Media samples and the glass bottles with the Extracting Media blanks, and store them at room temperature. Do not transfer the Extracting Media samples to alternative storage vessels.

HEAVY METALS— Pipet 20 mL of the Purified Water extract of the test bottles, filtered if necessary, into one of two matched 50-mL color-comparison tubes, and retain the remaining Purified Water extract in the test bottles for use in the test for Ethylene Glycol. Adjust the extract with 1 N acetic acid or 6 N ammonium hydroxide to a pH between 3.0 and 4.0, using short-range pH paper as an external indicator. Dilute with water to about 35 mL, and mix.

Total Terephthaloyl Moieties— Determine the absorbance of the 50 Percent Alcohol or 25 Percent Alcohol extract in a 1-cm cell at the wavelength of maximum absorbance at about 244 nm (see Spectrophotometry and Light-Scattering 851), using the corresponding Extracting Medium blank as the blank: the absorbance of the extract does not exceed 0.150, corresponding to not more than 1 ppm of total terephthaloyl moieties.

ETHYLENE GLYCOL—

The standards and tests provided in this section characterize polypropylene containers, produced from either homopolymers or copolymers, that are interchangeably suitable for packaging dry solid and liquid oral dosage forms.

Where suitable stability studies have been performed to establish the expiration date of a particular dosage form in the appropriate polypropylene container, then any other polypropylene container meeting these requirements may be similarly used to package such dosage form, provided that the appropriate stability programs are expanded to include the alternative container, in order to assure that the potency, identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.

Propylene polymers are long-chain polymers synthesized from propylene or propylene and other olefins under controlled conditions of heat and pressure, with the aid of catalysts. Examples of other olefins most commonly used include ethylene and butene. The propylene polymers, the ingredients used to manufacture the propylene polymers, and the ingredients used in the fabrication of the containers conform to the applicable sections of the Code of Federal Regulations, Title 21.

Factors such as plastics composition, processing and cleaning procedures, contacting media, inks, adhesives, absorption, adsorption and permeability of preservatives, and conditions of storage may also affect the suitability of a plastic for a specific use. The suitability of a specific polypropylene must be established by appropriate testing.

Polypropylene has a distinctive IR spectrum and possesses characteristic thermal properties. It has a density between 0.880 and 0.913 g per cm3. The permeation properties of molded polypropylene containers may be altered when reground polymer is incorporated, depending on the proportion of reground material in the final product. Other properties that may affect the suitability of polypropylene used in containers for packaging drugs are the following: oxygen and moisture permeability, modulus of elasticity, melt flow index, environmental stress crack resistance, and degree of crystallinity after molding. The requirements in this section are to be met when dry solid and liquid oral dosage forms are to be packaged in a container defined by this section.

APPARATUS— Use an IR spectrophotometer capable of correcting for the blank spectrum and equipped with a multiple internal reflectance accessory and a KRS-5 internal reflection plate. A KRS-5 crystal 2-mm thick having an angle of incidence of 45 provides a sufficient number of reflections.

PREPARATION OF SPECIMEN— Cut 2 flat sections, representative of the average wall thickness of the container, and trim them as necessary to obtain segments that are convenient for mounting in the internal reflectance accessory. Taking care to avoid scratching the surfaces, wipe the specimens with dry paper, or if necessary with a soft cloth dampened with methanol, and permit them to dry. Securely mount the specimens on both sides of the KRS-5 internal reflection plate, ensuring adequate surface contact. Prior to mounting the specimens on the plate, they may be compressed to flat uniform films by exposure to temperatures between 220 and 240. The specimen's time/temperature history during this operation should be limited to that necessary to mold the films.

PROCEDURE— Place the mounted specimen sections within the multiple internal reflectance accessory, and place the assembly in the specimen beam of the IR spectrophotometer. Adjust the specimen position and mirrors within the accessory to permit maximum light transmission of the unattenuated reference beam. (For a double beam instrument, upon completing the adjustment in the accessory, attenuate the reference beam to permit full-scale deflection during the scanning of the specimen.) Determine the IR spectrum from 3500 to 600 cm-1. The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of the USP Reference Standard for either a polypropylene homopolymer or copolymer, similarly determined.

HEAVY METALS— Containers meet the requirements for Heavy Metals under Physicochemical Tests—Plastics.

An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. Because the expiration date stated on the manufacturer's or distributor's package has been determined for the drug in that particular package and is not intended to be applicable to the product where it has been repackaged in a different container, repackaged drugs dispensed pursuant to a prescription are exempt from this expiration date labeling requirement. It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients.

The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.

In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication package (patient med pak).7

A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.

It is the responsibility of the dispenser to instruct the patient or caregiver on the use of the patient med pak.

the name of the patient;
a serial number for the patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;
the name, strength, physical description or identification, and total quantity of each drug product contained therein;
the directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;
any storage instructions or cautionary statements required by the official compendia;
the name of the prescriber of each drug product;
the date of preparation of the patient med pak and the beyond-use date or period of time assigned to the patient med pak (such beyond-use date or period of time shall be not longer than the shortest recommended beyond-use date for any dosage form included therein or not longer than 60 days from the date of preparation of the patient med pak and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein); alternatively, the package label shall state the date of the prescription(s) or the date of preparation of the patient med pak, provided the package is accompanied by a record indicating the start date and the beyond-use date;
the name, address, and telephone number of the dispenser (and the dispenser's registration number where necessary); and
any other information, statements, or warnings required for any of the drug products contained therein.

the name and address of the patient;
the serial number of the prescription order for each drug product contained therein;
the name of the manufacturer or labeler and lot number for each drug product contained therein;
information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;
the date of preparation of the patient med pak and the beyond-use date that was assigned;
any special labeling instructions; and
the name or initials of the pharmacist who prepared the patient med pak.