Subchapter A. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS

§ 25.1. Definitions.

 The following words and terms when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   Act—The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144).

   Department—The Department of Health of the Commonwealth.

   Device—Includes the following:

     (i)   An instrument, apparatus or contrivance, including their components, parts and accessories, intended as follows:

       (A)   For use in the diagnosis, cure, mitigation, treatment or prevention of disease of man or other animals.

       (B)   To affect the structure or a function of the body of man or other animals.

     (ii)   The term device shall include the following:

       (A)   Artificial eyes.

       (B)   Artificial limbs.

       (C)   Bandages and dressings, including, but not limited to, adhesive bandages, sterile gauze and cotton products, and elastic bandages and braces.

       (D)   Birth control devices, including, but not limited to, intrauterine devices, prophylactics, and vaginal diaphragms.

       (E)   Blood pressure testing apparatus.

       (F)   Body braces and supports, including, but not limited to, crutches, walkers and orthopedic braces and supports.

       (G)   Cardiac pacemakers and accessories.

       (H)   Colostomy and ileostomy appliances, bags and supplies.

       (I)   Corn pads or plasters.

       (J)   Dental materials which are transferred to the patient, including, but not limited to, dentures, fillings, crowns, inlays, bridges, and apparatus.

       (K)   Dialysis machines and artificial kidneys.

       (L)   Electronic therapeutic or diagnostic products.

       (M)   Eyeglasses and hard contact lenses.

       (N)   Hearing aids.

       (O)   Inhalation therapy equipment and emergency breathing equipment, including but not limited to atomizers, intermittent positive pressure breathing units, iron lungs, vaporizers, and oxygen equipment.

       (P)   Lamps, ultra-violet or infra-red.

       (Q)   Needles.

       (R)   Syringes.

       (S)   Physical therapy equipment for professional or home use, including but not limited to diathermy machines, electronic muscle stimulators, traction units, therapeutic vibrators, and whirlpool units.

       (T)   Surgical implants.

       (U)   Sutures.

       (V)   Thermometers.

       (W)   Urine test kits sold over-the-counter for home use.

       (X)   Wheelchairs.

   Secretary—The Secretary of Health of the Commonwealth.

   The provisions of this §  25.1 issued under section 2102 of The Administrative Code of 1929 (71 P. S. §  532); and sections 6 and 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-106 and 780-135).

   The provisions of this §  25.1 amended April 8, 1977, 7 Pa.B. 997. Immediately preceding text appears at serial page (17625).

GOOD MANUFACTURING PRACTICE IN MANUFACTURE,
PROCESSING, PACKING OR HOLDING OF DRUGS

§ 25.11. Buildings.

 Buildings shall be maintained in a clean and orderly manner and shall be of suitable size, construction, and location to facilitate adequate cleaning, maintenance, and proper operations in the manufacturing, processing, packing, labeling or holding of a drug. The buildings shall conform with the following:

   (1)  Provide adequate space for the following:

     (i)   Orderly placement of equipment and materials to minimize any risk of mixups between different drugs, drug components, in-process materials, packaging materials or labeling, and to minimize the possibility of contamination.

     (ii)   The receipt, storage and withholding from use of components pending sampling, identification, and testing prior to release by the materials approval unit for manufacturing and packaging.

     (iii)   The holding of rejected components prior to disposition to preclude the possibility of their use in manufacturing or packaging procedures for which they are unsuitable.

     (iv)   The storage of components, containers, packaging materials, and labeling.

     (v)   Any manufacturing and processing operations performed.

     (vi)   Any packaging or labeling operations.

     (vii)   Storage of finished products.

     (viii)   Control and production-laboratory operations.

   (2)  Provide adequate lighting, ventilation and screening and, when necessary for the intended production or control purposes, provide facilities for adequate air-pressure, microbiological, dust, humidity and temperature controls to insure the following:

     (i)   Minimize contamination of products by extraneous adulterants, including cross-contamination of one product by dust or particles of ingredients arising from the manufacture, storage or handling of another product.

     (ii)   Minimize dissemination of micro-organisms from one area to another.

     (iii)   Provide suitable storage conditions for drug components, in-process materials and finished drugs in conformance with stability information as derived under §  25.21 (relating to stability).

   (3)  Provide adequate locker facilities and hot and cold water washing facilities, including soap or detergent, air dryer or single service towels and clean toilet facilities near working areas.

   (4)  Provide an adequate supply of potable water under continuous positive pressure in a plumbing system free of defects that could cause or contribute to contamination of any drug. Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphonage.

   (5)  Provide suitable housing and space for the care of all laboratory animals.

 Equipment used for the manufacture, processing, packing, labeling, holding, testing or control of drugs shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction and location to facilitate cleaning, maintenance and operation for its intended purpose. These regulations permit the use of precision automatic, mechanical or electronic equipment in the production of drugs when adequate inspection and checking procedures are used to assure proper performance. The equipment shall conform with the following:

   (1)  Be so constructed that all surfaces that come into contact with a drug product shall not be reactive, additive or absorptive so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.

   (2)  Be so constructed that any substances required for operation of the equipment, such as lubricants or coolants, do not contact drug products so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.

   (3)  Be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance to assure the reliability of control procedures, uniformity of production, and exclusion from the drugs of contaminants from previous and current operations that might affect the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.

 (a)  A person may not operate as a manufacturer of drugs unless the drugs are manufactured under the supervision of a registered pharmacist, chemist or other person possessing at least 5 years’ experience in the manufacture of drugs or another person approved by the secretary as qualified by scientific or technical training or experience to perform the duties of supervision as may be necessary to protect the public health and safety.

 Components and other materials used in the manufacture, processing and packaging of drug products, and materials necessary for building and equipment maintenance, upon receipt shall be stored and handled in a safe, sanitary and orderly manner. Adequate measures shall be taken to prevent mixups and cross-contamination affecting drugs and drug products. Components shall be withheld from use until they have been identified, sampled and tested for conformance with established specifications and are released by a materials approval unit. Control of components shall include the following:

   (1)  Each container of component shall be examined visually for damage or contamination prior to use, including examination for breakage of seals when indicated.

   (2)  An adequate number of samples shall be taken from a representative number of component containers from each lot and shall be subjected to one or more tests to establish the specific identity.

   (3)  Representative samples of components liable to contamination with filth, insect infestation, or other extraneous contaminants shall be appropriately examined.

   (4)  Representative samples of all components intended for use as active ingredients shall be tested to determine their strength in order to assure conformance with appropriate specifications.

   (5)  Representative samples of components liable to microbiological contamination shall be subjected to microbiological tests prior to use. Such components shall not contain microorganisms that are objectionable in view of their intended use.

   (6)  Approved components shall be appropriately identified and retested as necessary to assure that they conform to appropriate specifications of identity, strength, quality, and purity at time of use. This requires the following:

     (i)   Approved components shall be handled and stored to guard against contaminating or being contaminated by other drugs or components.

     (ii)   Approved components shall be rotated in such a manner that the oldest stock is used first.

     (iii)   Rejected components shall be identified and held to preclude their use in manufacturing or processing procedures for which they are unsuitable.

   (7)  Appropriate records shall be maintained, including the following:

     (i)   The identity and quantity of the component, the name of the supplier, the supplier’s lot number, and the date of receipt.

     (ii)   Examinations and tests performed and rejected components and their disposition.

     (iii)   An individual inventory and record for each component used in each batch of drug manufactured or processed.

   (8)  An appropriately identified reserve sample of all active ingredients consisting of at least twice the quantity necessary for all required tests, except those for sterility and determination of the presence of pyrogens, shall be retained for at least 2 years after distribution of the last drug lot incorporating the component has been completed or 1 year after the expiration date of this last drug lot, whichever is longer.

 (a)  To assure uniformity from batch to batch, a master production and control record for each drug product and each batch size of drug product shall be prepared, dated, and signed or initialed by a competent and responsible individual and shall be independently checked, reconciled, dated and signed by a second competent and responsible individual. The master production and control record shall include:

   (1)  The name of the product, description, of the dosage form, and a specimen or copy of each label and all other labeling associated with the retail or bulk unit, including copies of such labeling signed or initialed and dated by the person or persons responsible for approval of such labeling.

   (2)  The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the finished drug, and a statement of the total weight or measure of any dosage unit.

   (3)  A complete list of ingredients designated by names or codes sufficiently specific to indicate any special quality characteristic; and accurate statement of the weight or measure of each ingredient regardless of whether it appears in the finished product, except that reasonable variations may be permitted in the amount of components necessary in the preparation in dosage form provided that provisions for such variations are included in the master production and control record; an appropriate statement concerning any calculated excess of an ingredient; an appropriate statement of theoretical weight or measure at various stages of processing; and a statement of the theoretical yield.

   (4)  A description of the containers, closures, and packaging and finishing materials.

   (5)  Manufacturing and control instructions, procedures, specifications, special notations, and precautions to be followed.

 (b)  The batch production and control record shall be prepared for each batch of drug produced and shall include complete information relating to the production and control of each batch. These records shall be retained for at least two years after the batch distribution is complete or at least 1 year after the batch expiration date, whichever is longer. These records shall identify the specific labeling and lot or control numbers used on the batch and shall be readily available during such retention period. The batch record shall include:

   (1)  An accurate reproduction of the appropriate master formula record checked, dated, and signed or initialed by a competent and responsible individual.

   (2)  A record of each significant step in the manufacturing, processing, packaging, labeling, testing, and controlling of the batch, including dates, individual major equipment and lines employed; specific identification of each batch of components used; weights and measures of components and products used in the course of processing; in-process and laboratory control results; and identifications of the individuals actively performing and the individuals directly supervising or checking each significant step in the operation.

   (3)  A batch number that identifies all the production and control documents relating to the history of the batch and all lot or control numbers associated with the batch.

 Production and control procedures shall include all reasonable precautions, including the following, to assure that the drugs produced have the safety, identity, strength, quality, and purity they purport to possess:

   (1)  Each significant step in the process, such as the selection, weighing, and measuring of components, the addition of ingredients during the process, weighing and measuring during various stages of the processing, and the determination of the finished yield, shall be performed by a competent and responsible individual and checked by a second competent and responsible individual; or if such steps in the processing are controlled by precision automatic, mechanical, or electronic equipment, their proper performance is adequately checked by one or more competent and responsible individuals. The written record of the significant steps in the process shall be identified by the individual performing these tests and by the individual charged with checking these steps. Such identifications shall be recorded immediately following the completion of such steps.

   (2)  All containers, lines, and equipment used during the production of a batch of a drug shall be properly identified at all times to accurately and completely indicate their contents and, when necessary, the stage of processing of the batch.

   (3)  To minimize contamination and prevent mixups, equipment, utensils, and containers shall be thoroughly and appropriately cleaned and properly stored and have previous batch identification removed or obliterated between batches or at suitable intervals in continuous production operations.

   (4)  Appropriate precautions shall be taken to minimize microbiological and other contamination in the production of drugs purporting to be sterile or which by virtue of their intended use should be free from objectionable micro-organisms.

   (5)  Appropriate procedures shall be established to minimize the hazard of cross-contamination of any drugs while being manufactured or stored.

   (6)  To assure the uniformity and integrity of products, there shall be adequate in-process controls, such as checking the weights and disintegration times of tablets, the adequacy of mixing, the homogeneity of suspensions, and the clarity of solutions. In-process sampling shall be done at appropriate intervals using suitable equipment.

   (7)  Representative samples of all dosage form drugs shall be tested to determine their conformance with the specifications for the product before distribution.

   (8)  Procedures shall be instituted whereby review and approval of all production and control records, including packaging and labeling, shall be made prior to the release or distribution of a batch. A thorough investigation of any unexplained discrepancy or the failure of a batch to meet any of its specifications shall be undertaken whether or not the batch has already been distributed. This investigation shall be undertaken by a competent and responsible individual and shall extend to other batches of the same drug and other drugs that may have been associated with the specific failure. A written record of the investigation shall be made and shall include the conclusions and followup.

   (9)  Returned goods shall be identified as such and held. If the conditions under which returned goods have been held, stored, or shipped prior to or during their return, or the condition of the product, its container, carton, or labeling as a result of storage or shipping, cast doubt on the safety, identity, strength, quality, or purity of the drug, the returned goods shall be destroyed or subjected to adequate examination or testing to assure that the material meets all appropriate standards or specifications before being returned to stock for warehouse distribution or repacking. If the product is neither destroyed nor returned to stock, it may be reprocessed provided the final product meets all its standards and specifications. Records of returned goods shall be maintained and shall indicate the quantity returned, date, and actual disposition of the product. If the reason for returned goods implicates associated batches, an appropriate investigation shall be made in accordance with the requirements of paragraph (8).

 Packaging and labeling operations shall be adequately controlled: To assure that only those drug products that have met the standards and specifications established in their master production and control records shall be distributed; to prevent mixups between drugs during filling, packaging, and labeling operations; to assure that correct labels and labeling are employed for the drug; and to identify the finished product with a lot or control number that permits determination of the history of the manufacture and control of the batch. An hour, day, or shift code is appropriate as a lot or control number for drug products manufactured or processed in continuous production equipment. Packaging and labeling operations shall conform with the following:

   (1)  Be separated, physically or spatially, from operations on other drugs in a manner adequate to avoid mixups and minimize cross-contamination. Two or more packaging or labeling operations having drugs, containers, or labeling similar in appearance shall not be in process simultaneously on adjacent or nearby lines unless these operations are separated either physically or spatially.

   (2)  Provide for an inspection of the facilities prior to use to assure that all drugs and previously used packaging and labeling materials have been removed.

   (3)  Include the following labeling controls:

     (i)   The holding of labels and package labeling upon receipt pending review and proofing against an approved final copy by a competent and responsible individual to assure that they are accurate regarding identity, content, and conformity with the approved copy before release to inventory.

     (ii)   The maintenance and storage of each type of label and package labeling representing different products, strength, dosage forms, or quantity of contents in such a manner as to prevent mixups and provide proper identification.

     (iii)   A suitable system for assuring that only current labels and package labeling are retained and that stocks of obsolete labels and package labeling are destroyed.

     (iv)   Restriction of access to labels and package labeling to authorized personnel.

     (v)   Avoidance of gang printing of cut labels, cartons, or inserts when the labels, cartons, or inserts are for different products or different strengths of the same products or are of the same size and have identical or similar format and/or color schemes. If gang printing is employed, packaging and labeling operations shall provide for added control procedures. These added controls should consider sheet layout, stacking, cutting and handling during and after printing.

   (4)  Provide strict control of the package labeling issued for use with the drug. Such issue shall be carefully checked by a competent and responsible person for identity and conformity to the labeling specified in the batch production record. Said record shall identify the labeling and the quantities issued and used and shall reasonably reconcile any discrepancy between the quantity of drug finished and the quantities of labeling issued. All excess package labeling bearing lot or control numbers shall be destroyed. In event of any significant unexplained discrepancy, an investigation should be carried out according to §  25.16(h) (relating to production and control procedures).

   (5)  Provide for adequate examination or laboratory testing of representative samples of finished products after packaging and labeling to safeguard against any errors in the finishing operations and to prevent distribution of any batch until all specified tests have been met.

 Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, and test procedures to assure that components, in-process drugs, and finished products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include the following:

   (1)  The establishment of master records containing appropriate specifications for the acceptance of each lot of drug components, product containers, and their components used in drug production and packaging and a description of the sampling and testing procedures used for them. Said samples shall be representative and adequately identified. Such records shall also provide for appropriate retesting of drug components, product containers, and their components subject to deterioration.

   (2)  A reserve sample of all active ingredients as required by §  25.14 (8) (relating to components).

   (3)  The establishment of master records, when needed, containing specifications and a description of sampling and testing procedures for in-process drug preparations. Such samples shall be adequately representative and properly identified.

   (4)  The establishment of master records containing a description of sampling procedures and appropriate specifications for finished drug products. Such samples shall be adequately representative and properly identified.

   (5)  Adequate provisions for checking the identity and strength of drug products for all active ingredients and for assuring:

     (i)   Sterility of drugs purported to be sterile and freedom from objectionable micro-organisms for those drugs which should be so by virtue of their intended use.

     (ii)   The absence of pyrogens for those drugs purporting to be pyrogen-free.

     (iii)   Minimal contamination of ophthalmic ointments by foreign particles and harsh or abrasive substances.

     (iv)   That the drug release pattern of sustained release products is tested by laboratory methods to assure conformance to the release specifications.

   (6)  Adequate provision for auditing the reliability, accuracy, precision, and performance of laboratory test procedures and laboratory instruments used.

   (7)  A properly identified reserve sample of the finished product (stored in the same immediate container closure system in which the drug is marketed) consisting of at least twice the quanitity necessary to perform all the required tests, except those for sterility and determination of the absence of pyrogens, and stored under conditions consistent with product labeling shall be retained for at least 2 years after the drug distribution has been completed or at least 1 year after the drug’s expiration date, whichever is longer.

   (8)  Provision for retaining complete records of all laboratory data relating to each batch or lot of drug to which they apply. Such records shall be retained for at least 2 years after distribution has been completed or 1 year after the drug’s expiration date, whichever is longer.

   (9)  Provision that animals shall be maintained and controlled in a manner that assures suitability for their intended use. They shall be identified and appropriate records maintained to determine the history of use.

 (a)  Finished goods warehouse control and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. Records within the system shall contain the name and address of the consignee, date and quantity shipped, and lot or control number of the drug. Records shall be retained for at least 2 years after the distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever is longer.

 There shall be assurance of the stability of finished drug products. This stability shall be in accordance with the following:

   (1)  Determined by reliable, meaningful, and specific test methods.

   (2)  Determined on products in the same container closure systems in which they are marketed.

   (3)  Determined on any dry drug product that is to be reconstituted at the time of dispensing, as directed in its labeling, as well as on the reconstituted product.

   (4)  Recorded and maintained in such manner that the stability data may be utilized in establishing product expiration dates.

 To assure that drug products liable to deterioration meet appropriate standards of identity, strength, quality, and purity at the time of use, the label of all such drugs shall have suitable expiration dates which relate to stability tests performed on the products.

   (1)  Expiration dates appearing on the drug labeling shall be justified by readily available data from stability studies such as described in §  25.21 (relating to stability).

   (2)  Expiration dates shall be related to appropriate storage conditions stated on the labeling wherever the expiration date appears.

 Records shall be maintained of all written and oral complaints regarding each product. An investigation of each complaint shall be made in accordance with §  25.16(8) (relating to production and control procedures). The record of each investigation shall be maintained for at least 2 years after distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever is longer.

STANDARDS OF OPERATION FOR DRUG, DEVICE OR
COSMETIC DISTRIBUTORS

§ 25.31. Sanitation requirements.

 Those areas of drug, device or cosmetic distributing establishments where drugs, devices or cosmetics are warehoused or stored shall be maintained in a clean, orderly condition, free from vermin infestations, accumulated waste and debris. Preventive measures shall include, but shall not be limited to, the following:

   (1)  Warehousing facilities shall be of construction, material, and finish that will permit the ready and efficient cleaning of all surfaces, having regard to the nature of the operations being performed.

   (2)  Adequate lighting shall be provided in all working areas.

   (3)  Sufficient working and storage space shall be provided to permit adequate cleaning and housekeeping.

   (4)  The establishments shall be free from accumulations of water not necessary for operational or sanitation procedures.

   (5)  Proper and adequate toilet facilities shall be provided and kept in satisfactory condition at all times with sufficient lighting and ventilation. Such facilities shall be separate from operational areas of such establishments. Handwashing facilities shall be available and rules shall require their use before returning to work.

 (a)  Establishments warehousing products which require refrigeration shall be equipped with adequate facilities for storage at the proper reduced temperatures.

 (b)  Distributors dealing in controlled substances shall have adequate storage facilities and safeguards to comply with the regulations of the Federal Drug Enforcement Administration.

 (c)  Distributors dealing in drugs shall have adequate storage facilities and safeguards to prevent loss or minimize deterioration.

 (d)  Each distributor’s establishment shall provide for a systematic rotation of stock.

 (e)  Damaged, out-dated or otherwise unfit drugs, devices or cosmetics not in conformity with the provisions of the act or regulations thereunder, shall be removed from active stock and held for proper disposition in a quarantine or other clearly defined area.

 (f)  A distributor dealing in nonproprietary drugs or controlled substances shall have operating and storage facilities which have entrances used only by that distributor and which are separate from living quarters. Facilities shall be secured so that persons in an adjoining structure, business or residence cannot traverse through the operating and storage areas used for nonproprietary drugs or controlled substances.

   The provisions of this §  25.32 issued under section 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-135); and section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)).

 (a)  Distributing establishments shall not distribute nonproprietary drugs or controlled substances to persons unauthorized by the act to receive them.

 (b)  No person shall buy, sell, cause to be sold or offer for sale any drug or device which bears or which package bears or originally did bear, the inscription ‘‘sample’’ or ‘‘not for sale’’ or words of similar import. This subsection does not apply to the production of promotional samples by one manufacturer for distribution by another manufacturer.

 (c)  Distributors shall keep records of all purchases or other receipts and sales or other distribution of drugs, devices and controlled substances, other than those exempt by regulation, for 2 years from the date of receipt and distribution. Such records shall include the following:

   (1)  Name and address of person from whom received.

   (2)  Name and address of person to whom distributed.

   (3)  Date of receipt and distribution.

 (a)  The personnel responsible for the supervision of a drug, device or cosmetic distributing establishment shall have appropriate technical qualifications or shall be qualified by job training and experience, to assure the proper handling of products in the establishment.

 (b)  No person may operate as a distributor of nonproprietary drugs or controlled substances unless the distribution is performed while a registered pharmacist, chemist or other person who possesses at least 3 years experience in the distribution or sale of drugs or controlled substances is present in the distributing establishment and is responsible for the activities. Other persons may meet this requirement for supervision, if approved by the Secretary as qualified by scientific training to perform the duties of supervision.

   The provisions of this §  25.34 issued under section 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-135); and section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)).

   The provisions of this §  25.34 amended September 12, 1986, effective September 13, 1986, 16 Pa.B. 3396. Immediately preceding text appears at serial page (96886).

EMERGENCY DISPENSING

§ 25.41. Pharmacist.

 A pharmacist may dispense to the ultimate user a controlled substance listed in Schedule II which is a prescription drug as determined under the Federal Food Drug and Cosmetic Act, 21 U.S.C.A. §  812 upon receiving oral authorization without the written prescription order of a licensed practitioner only under the following emergency situations:

   (1)  That immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.

   (2)  That no appropriate alternative treatment is available including administration of a drug that is not a controlled substance under Schedule II of the act, 21 U.S.C.A. §  812.

 The quantity prescribed and dispensed under emergency conditions is limited to the amount adequate to treat the patient during the emergency period.

 The prescription shall be immediately reduced to writing by the pharmacist and shall contain all the information required under section 4 of the act (35 P. S. §  780-104) except the signature of the prescribing licensed practitioner.

 If the prescribing practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a licensed practitioner, which may include a call back to the practitioner using the phone number listed in the telephone directory of other good faith efforts to insure his identity.

 Within 72 hours after authorizing an emergency oral prescription, the prescribing practitioner shall have a written prescription for the emergency quantity prescribed delivered to the dispensing pharmacist. In addition to conforming to the requirements of these regulations, and the act, the prescription shall have written on its face ‘‘Authorization for Emergency Dispensing’’ and the date of the oral order. Upon receipt the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing.

 The pharmacist shall notify the nearest office of the Federal Drug Enforcement Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this section to dispense a controlled substance without a written prescription of a prescribing individual practitioner.

   This section cited in 28 Pa. Code §  551.3 (relating to definitions).

PRESCRIPTIONS

§ 25.51. Definition of ‘‘prescription.’’

 The term ‘‘prescription’’ or ‘‘prescription order’’ means an order for a controlled substance, other drug, or device for medication which is dispensed to or for an ultimate user, but does not include an order for a controlled substance, other drug, or device for medication which is dispensed for immediate administration to the ultimate user. For example, an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription order.

 (a)  A prescription for a controlled substance must be issued for a legitimate medical purpose by a licensed practitioner in the usual course of professional practice. The responsibility for proper prescribing of controlled substances is upon the practitioner but a corresponding responsibility rests with the pharmacist who dispenses the medication and interprets the directions of the prescriber to the patient.

 (b)  A prescription may not be issued by a practitioner to obtain controlled substances for use in his routine office practice nor for general dispensing to his patients.

 (c)  A prescription may not be issued for the dispensing of controlled substances listed in any schedule to a drug dependent person for the purpose of continuing his dependence upon such drugs, nor in the course of conducting an authorized clinical investigation in a narcotic dependency rehabilitation program.

   A pharmacist who fills numerous prescriptions emanating from a dentist for medications which clearly do not comport with a dental practice (such as birth control drugs and unusually large dosages of valium) violates the standards of his profession and the duty imposed by the provisions of this section. Askin v. Department of Public Welfare, 423 A.2d 1371 (Pa. Cmwlth. 1981).

 (a)  Prescription orders may be written on prescription blanks or may be oral, if allowed by law.

 (b)  If prescriptions are issued in writing, the bottom of every prescription blank shall be imprinted with the words ‘‘substitution permissible’’ and shall contain one signature line for the physician’s or other authorized prescriber’s signature. The prescriber’s signature shall validate the prescription, and unless the prescriber handwrites ‘‘brand necessary’’ or ‘‘brand medically necessary’’ shall designate approval of substitution of a drug by a pharmacist, pursuant to the act. Imprinted conspicuously on the prescription blanks shall be the words: IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRESCRIBER MUST HANDWRITE ‘‘BRAND NECESSARY’’ OR ‘‘BRAND MEDICALLY NECESSARY’’ IN THE SPACE BELOW.’’ Information printed on the prescription blank shall be in 8 point, upper-case print. The following example would be acceptable:
SUBSTITUTION PERMISSIBLE

 (c)  If prescription orders are given orally, substitution is permissible unless the prescriber expressly indicates to the pharmacist that the brand name drug is necessary and that substitution is not allowed.

 (d)  Prescriptions for controlled substances shall be written in indelible ink, indelible pencil or typewriter and shall include the following information:

   (1)  The date of issue.

   (2)  The name and address of the patient, or if the patient is an animal, the name and address of the owner and the species of the animal.

   (3)  Directions for administration.

   (4)  The name, address and Federal Drug Enforcement Administration registration number of the prescribing practitioner.

   (5)  The signature of the prescribing practitioner in the manner described in subsection (b).

 (e)  The Federal Drug Enforcement Administration registration number cannot be preprinted on the prescription form.

   The provisions of this §  25.53 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5); amended under section 3 of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5); and section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)).

   The provisions of this §  25.53 amended through June 24, 1977, 7 Pa.B. 1815; amended October 26, 1990, effective October 27, 1990, 20 Pa.B. 5426. Immediately preceding text appears at serial pages (116446) to (116447).

 (a)  Every pharmacy shall post a sign which shall read as follows: ‘‘PENNSYLVANIA LAW PERMITS PHARMACISTS TO SUBSTITUTE A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE.’’ This sign will be printed in boldface letters not less than one inch or 2.54 centimeters in height on a white background and posted in a prominent place that is in clear and unobstructed public view at or near the place where prescriptions are dispensed.

 (b)  Every pharmacy shall post in a conspicuous place, easily accessible to the general public, a list of commonly used generically equivalent drug products from the Department Formulary containing brand names, names of the manufacturers, and generic names. This list shall be alphabetized by brand name, each of which shall be followed by the generic name, and printed in boldface type clearly legible and accessible to the general public.

 (c)  Every pharmacy shall have available to the public a listing of the regular and customary retail prices of that pharmacy for brand name and generic equivalent drug products, with the name of the manufacturer, available for selection by the person presenting the prescription.

   The provisions of this §  25.54 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5).

   The provisions of this §  25.54 amended June 24, 1977, 7 Pa.B. 1742. Immediately preceding text appears at serial page (17641).

 (a)  Where the pharmacist is to substitute a less expensive generically equivalent drug for a brand name drug at the pharmacy, notification to the person presenting the prescription shall be made by the pharmacist, either directly or through a pharmacy intern or other person under the supervision of the pharmacist authorized to assist the pharmacist by the State Board of Pharmacy. Such notification shall be limited to advising the person presenting the prescription that substitution is possible, to advising the person of the amount of the retail price difference between the brand name and the generically equivalent drug product substituted for it, and to informing the person that he may refuse the substitution. Questions by the person presenting the prescription for drug product information shall be answered only by the pharmacist or pharmacy intern. The notification described in this subsection of a possible substitution and retail price difference may be oral or may be in a written statement similar to the following: ‘‘Your

   (2)  After receiving a prescription order by mail, a mail order pharmacy shall substitute a less expensive generically equivalent drug product listed in the Formulary unless expressly directed otherwise by the person presenting the prescription or the prescribing physician.

   (3)  When a generically equivalent drug product is dispensed by mail, the pharmacy shall notify the person presenting the prescription of the substitution and shall indicate the retail price difference between the brand name drug and the generic equivalent drug product substituted for it.

 (c)  Any pharmacist substituting a less expensive drug product shall charge the person presenting the prescription the regular and customary retail price of that pharmacy for the generically equivalent drug.

 (d)  No pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type is not included in the Formulary developed by the Department and found at §  25.58 (relating to generically equivalent drug products).

 (e)  Prescription refills, where permitted by the practitioner, shall be completed using the identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the prescription and the practitioner authorize in advance a different manufacturer’s generic equivalent product. Advance authorization is not required in an emergency, but the physician shall be notified by the pharmacist as soon as possible thereafter.

   The provisions of this §  25.55 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5).

   The provisions of this §  25.55 amended June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742. Immediately preceding text appears at serial pages (17641) and (17642).

 (a)  Prescription orders for controlled substances in Schedules I and II shall be maintained in a file separate from all other records of the pharmacy.

 (b)  Prescription orders for controlled substances in Schedules III, IV and V shall be maintained either in a separate prescription file or in such form that they are readily retrievable from the other prescription records of the pharmacy. They will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is marked in red ink in the lower right corner with the letter ‘‘C,’’ no less than one inch high and filed in the usual consecutively numbered prescription file for noncontrolled substances.

 (c)  When a pharmacist substitutes a generically equivalent drug product for a brand name product, he shall maintain a record of the substitution by making a notation indicating the generic equivalent drug name, using abbreviations if necessary, and the name of the manufacturer and distributor of the product dispensed on the original prescription order retained by the pharmacist, or the pharmacist may store it in a functionally equivalent retrieval system.

   The provisions of this §  25.56 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5).

   The provisions of this §  25.56 adopted June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.

 A controlled substance listed in Schedules III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § §  301—392, may be dispensed without a prescription to a purchaser at retail provided that the following conditions are met:

   (1)  Such distribution is made only by a registered pharmacist and not by a nonpharmacist employe even if under the direct supervision of a pharmacist; although, after the pharmacist has fulfilled his professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist.

   (2)  Not more than 240 milliliters, eight fluid or avoirdupois ounces of any such controlled substance listed in Schedule V containing opium nor more than 120 milliliters, four fluid or avoirdupois ounces of any other controlled substance listed in Schedule V may be distributed at retail to the same purchaser in a given 72-hour period, except under a written or oral prescription of a licensed practitioner in possession of a DEA number.

   (3)  The purchaser is at least 18 years of age.

   (4)  The pharmacist requires every purchaser of a controlled substance listed in Schedule V not known to him to furnish suitable identification, including proof of age where appropriate.

   (5)  A bound record book for distributions of controlled substances, other than by prescription order, is maintained by the pharmacist. This book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the dispensing pharmacist.

   (6)  No individual other than a registered manufacturer, distributor, practitioner, or pharmacy in possession of a Federal DEA registration shall acquire or attempt to acquire controlled substances containing opium listed in Schedule V in excess of eight fluid or avoirdupois ounces nor any other controlled substance if listed in Schedule V in excess of four fluid or avoirdupois ounces for any individual in a 72-hour period, except when dispensed pursuant to a prescription or prescription order.

   The provisions of this §  25.57 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §  960.5).

   The provisions of this §  25.57 adopted June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.

 The following is a formulary of generically equivalent drug products and the names of their corresponding distributors and manufacturers:


ACETAMINOPHEN
Capsules

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Acetaminophen   Danbury Pharmacal   Danbury Pharmacal

   Acetaminophen   West-ward   West-ward

   Acetaminophen   Henry Schein   West-ward

   Acetaminophen   Gen-King Products   West-ward

   Halenol   Halsey Drug   Halsey Drug

   Acetaminophen   United Research Labs   Halsey Drug

   Acetaminophen   Glenlawn Labs   Halsey Drug

   Acetaminophen   Geneva Generics   Cord Labs

   Acetaminophen   Superpharm Corp   Superpharm Corp

   Biolenol   Bioline Labs   Superpharm Corp

   Acetaminophen   Parmed Pharmaceuticals   KV Pharmaceutical

   Amidol   Amide Pharmaceutical   Amide Pharmaceutical

   Acetaminophen   United Research Labs   Pharmacaps

   Acetaminophen   United Research Labs   Sidmak Labs

   Acetaminophen   United Research Labs   B T Products

   Acetaminophen   United Research Labs   Ohm Labs

   Acetaminophen   Barr Labs   Barr Labs

   Acetaminophen   Rugby Labs   Chelsea Labs

   Acetaminophen   American Therapeutics   American Therapeutics

   Acetaminophen   Mutual Pharmaceutical   Mutual Pharmaceutical
ACETAMINOPHEN
Capsules—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Acetaminophen   United Research Labs   Mutual Pharmaceutical

   Acetaminophen   Genetco   Mutual Pharmaceutical
ACETAMINOPHEN
Chewable Tablets

   Tylenol   McNeil Labs   McNeil Labs
ACETAMINOPHEN
Elixir

   Acetaminophen   Lederle Labs   National Pharmaceutical

   Acetaminophen   United Research Labs   National Pharmaceutical

   Acetaminophen   Peoples Drug   National Pharmaceutical

   Acetaminophen   Vangard Labs   National Pharmaceutical

   Acetaminophen   Ascot   National Pharmaceutical

   APAP   Barre Drug   National Pharmaceutical

   APAP   Bioline Labs   National Pharmaceutical

   APAP   Henry Schein   National Pharmaceutical

   APAP   H L Moore Drug Exchange   National Pharmaceutical

   APAP   ACA   National Pharmaceutical

   APAP   Murray Drug   National Pharmaceutical

   APAP   Harber Pharmaceutical   National Pharmaceutical

   APAP   Rugby Labs   National Pharmaceutical

   Pampa   Pharmco   National Pharmaceutical

   Fendon   American Pharmaceutical   National Pharmaceutical

   Revinol   Revco Drug   National Pharmaceutical

   Tylenol   McNeil Labs   McNeil Labs

   Acetaminophen   Rugby Labs   West-ward

   Acetaminophen   West-ward   West-ward

   Acetaminophen Pediatric   Lannett   Lannett

   Liquinol   Life Labs   Life Labs

   Acetaminophen   Purepac Pharmaceutical   Purepac Pharmaceutical

   Acetaminophen   Superpharm Corp   Superpharm Corp

   APAP   Henry Schein   Halsey Drug

   Halenol   Halsey Drug   Halsey Drug

   APAP   Rugby Labs   Naska Pharmacal

   APAP   Goldline Labs   Barre-National
ACETAMINOPHEN
Solution

   Tylenol Drops   McNeilab   McNeilab

   Myapap   My-K Labs   My-K Labs
ACETAMINOPHEN
Suppositories

   Acephen   G & W Labs   G & W Labs

   Acetaminophen   West-ward   G & W Labs

   Acetaminophen   United Research Labs   G & W Labs

   Acetaminophen   Upsher-Smith   Upsher-Smith

   Acetaminophen   Geneva Generics   Chase Chemical
ACETAMINOPHEN
Tablets

   Acetaminophen   Richlyn Labs   Richlyn Labs

   Acetaminophen   Purepac Pharmaceutical   Purepac Pharmaceutical

   Acetaminophen   Barr Labs   Barr Labs

   Acetaminophen   Roxane Labs   Roxane Labs

   Acetaminophen   ICN Pharmaceuticals   ICN Pharmaceuticals

   Acetaminophen   West-ward   West-ward

   Acetaminophen   Danbury Pharmacal   Danbury Pharmacal

   Acetaminophen   Geneva Generics   Danbury Pharmacal

   Acetaminophen   McKesson Labs   MK Labs

   Acetaminophen   Lederle Labs   Lederle Labs

   Acetaminophen   United Research Labs   Sidmak Labs

   Acetaminophen   United Research Labs   B T Products

   Acetaminophen   United Research Labs   Ohm Labs

   Acetaminophen   United Research Labs   Bowman Pharmaceuticals

   Acetaminophen   Bowman Pharmaceuticals   Bowman Pharmaceuticals

   Acetaminophen   American Therapeutics   American Therapeutics

   APAP   Heather Drug   Heather Drug

   APAP   Rugby Labs   Chelsea Labs

   APAP   Lannett   Lannett
ACETAMINOPHEN
Tablets—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   APAP   Superpharm Corp   Superpharm Corp

   Biolenol   Bioline Labs   Superpharm Corp

   Amidol   Amide Pharmaceutical   Amide Pharmaceutical

   Tylenol   McNeil Labs   McNeil Labs

   Valadol   E R Squibb & Sons   E R Squibb & Sons

   Tapar   Parke-Davis   Parke-Davis

   Acetaminophen   United Research Labs   Danbury Pharmacal

   Acetaminophen   Mutual Pharmaceutical   Mutual Pharmaceutical

   Acetaminophen   United Research Labs   Mutual Pharmaceutical

   Acetaminophen   J J Balan   Mutual Pharmaceutical

   Acetaminophen   Vita-Rx   Mutual Pharmaceutical

   Acetaminophen   Genetco   Mutual Pharmaceutical

   Acetaminophen   Warner Chilcott Labs   Mutual Pharmaceutical
ACETAMINOPHEN/BUTALBITAL/CAFFEINE
Tablets

   Butalbital, APAP and
 Caffeine   Halsey Drug   Halsey Drug

   Butalbital, APAP and
 Caffeine   United Research Labs   Halsey Drug

   Butalbital, Acetaminophen
 and Caffeine   Geneva Generics   Halsey Drug
ACETAMINOPHEN/CHLORPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL
Tablets

   Sinus   American Therapeutics   American Therapeutics
ACETAMINOPHEN/CODEINE PHOSPHATE
Capsules

   Phenaphen w/Codeine   A H Robins   A H Robins

   Acetaminophen and Codeine
Phosphate   Qualitest   Zenith Labs

   Acetaminophen/Codeine   Major Pharmaceutical Corp   American Therapeutics
ACETAMINOPHEN/CODEINE PHOSPHATE
Elixir

   APAP w/Codeine   Barre Drug   National Pharmaceutical

   APAP w/Codeine   Henry Schein   National Pharmaceutical

   APAP w/Codeine   Rugby Labs   National Pharmaceutical

   APAP w/Codeine   Glenlawn Labs   National Pharmaceutical

   APAP w/Codeine   Bioline Labs   National Pharmaceutical

   APAP w/Codeine   Bell Pharmacal   National Pharmaceutical

   APAP w/Codeine   United Research Labs   National Pharmaceutical

   APAP w/Codeine   Qualitest   National Pharmaceutical

   APAP w/Codeine   Goldline Labs   Barre-National

   Tylenol with Codeine   McNeil Labs   McNeil Labs

   Myapap and Codeine   My-K Labs   My-K Labs

   Acetaminophen/Codeine   Roxane Labs   Roxane Labs

   Acetaminophen/Codeine   Pharmaceutical Basics   Pharmaceutical Basics
ACETAMINOPHEN/CODEINE PHOSPHATE
Tablets

   Acetaminophen/Codeine   Roxane Labs   Roxane Labs

   SK-APAP w/Codeine   Smith, Kline & French Labs   Roxane Labs

   Empracet/Codeine   Burroughs-Wellcome   Burroughs-Wellcome

   Acetaminophen/Codeine   Halsey Drug   Halsey Drug

   Acetaminophen/Codeine   Rugby Labs   Halsey Drug

   Acetaminophen/Codeine   Henry Schein   Halsey Drug

   Acetaminophen/Codeine   Purepac Pharmaceutical   Halsey Drug

   Acetaminophen/Codeine   Interstate Drug Exchange   Halsey Drug

   Acetaminophen/Codeine   Towne, Paulsen   Towne, Paulsen

   Acetaminophen/Codeine   Parke-Davis   Parke-Davis

   Acetaminophen/Codeine   United Research Labs   Halsey Drug

   Tylenol with Codeine   McNeil Labs   McNeil Labs

   Acetaminophen/Codeine   Lemmon Co   Lemmon Co

   Acetaminophen/Codeine   Zenith Labs   Zenith Labs

   Acetaminophen/Codeine   Gen-King Products   Zenith Labs

   Acetaminophen/Codeine   H L Moore Drug Exchange   Zenith Labs

   Acetaminophen/Codeine   Interstate Drug Exchange   Zenith Labs

   Acetaminophen/Codeine   Regal Labs   Zenith Labs

   Acetaminophen/Codeine   Murray Drug   Zenith Labs
ACETAMINOPHEN/CODEINE PHOSPHATE
Tablets—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Acetaminophen/Codeine   Henry Schein   Zenith Labs

   Acetaminophen/Codeine   Cooper   Zenith Labs

   Acetaminophen/Codeine   Cord Labs   Cord Labs

   Acetaminophen/Codeine   Geneva Generics   Cord Labs

   Acetaminophen/Codeine   Purepac Pharmaceutical   Purepac Pharmaceutical

   Acetaminophen/Codeine   Gen-King Products   Halsey Drug

   Acetaminophen/Codeine   Glenlawn Labs   Halsey Drug

   Acetaminophen/Codeine   H L Moore Drug Exchange   Halsey Drug

   Acetaminophen/Codeine   Murray Drug   Halsey Drug

   Codaca   Arkansas Cooperative   Halsey Drug

   APAP w/Codeine Phosphate   Bioline Labs   Halsey Drug

   Acetaminophen/Codeine   Barr Labs   Barr Labs

   Acetaminophen/Codeine   Rugby Labs   Barr Labs

   Acetaminophen/Codeine   Bell Pharmacal   Zenith Labs

   Acetaminophen/Codeine   Rugby Labs   Chelsea Labs

   Acetaminophen/Codeine   KV Pharmaceutical   KV Pharmaceutical

   Acetaminophen/Codeine   Parmed Pharmaceuticals   KV Pharmaceutical

   Acetaminophen/Codeine   Duramed Pharmaceuticals   Duramed Pharmaceuticals

   Acetaminophen/Codeine   Parmed Pharmaceuticals   Towne, Paulsen

   Acetaminophen/Codeine   Parmed Pharmaceuticals   Boots Labs

   Acetaminophen/Codeine   Boots Labs   Boots Labs

   Acetaminophen/Codeine   United Research Labs   Lemmon Co

   Acetaminophen/Codeine   Richie Pharmacal   Lemmon Co

   Acetaminophen/Codeine   Interstate Drug Exchange   Lemmon Co

   Acetaminophen/Codeine   Purepac Pharmaceutical   Lemmon Co

   Acetaminophen/Codeine   Purepac Pharmaceutical   Barr Labs

   Acetaminophen/Codeine   Geneva Generics   Zenith Labs

   Acetaminophen/Codeine   Qualitest   Zenith Labs

   Acetaminophen/Codeine   Vitarine Pharmaceutical   Vitarine Pharmaceutical

   Acetaminophen/Codeine   Geneva Generics   Vitarine Pharmaceutical

   Acetaminophen/Codeine   Superpharm Corp   Superpharm Corp

   Acetaminophen/Codeine   Bioline Labs   Superpharm Corp

   Acetaminophen/Codeine   Goldline Labs   Superpharm Corp

   Acetaminophen/Codeine   Rondex Labs   Kalipharma

   Acetaminophen/Codeine   Goldline Labs   Zenith Labs

   Acetaminophen/Codeine   Major Pharmaceutical Corp   Zenith Labs

   Acetaminophen/Codeine   Bioline Labs   Zenith Labs

   Acetaminophen/Codeine   American Therapeutics   American Therapeutics

   Acetaminophen/Codeine   Qualitest   Halsey Drug

   Acetaminophen/Codeine   Goldline Labs   Halsey Drug

   Acetaminophen/Codeine   Mutual Pharmaceutical   Mutual Pharmaceutical

   Acetaminophen/Codeine   United Research Labs   Mutual Pharmaceutical

   Acetaminophen/Codeine   J J Balan   Mutual Pharmaceutical

   Acetaminophen/Codeine   Warner Chilcott Labs   Mutual Pharmaceutical

   Acetaminophen/Codeine   Genetco   Mutual Pharmaceutical

   Acetaminophen/Codeine   Dixon-Shane   Mutual Pharmaceutical

   Acetaminophen/Codeine   Medicopharma   Charlotte Pharm.
ACETAMINOPHEN/DICHLORALPHENAZONE/ISOMETHEPTENE MUCATE
Capsules

   Isocom   Nutripharm Labs   Central Pharmaceuticals
ACETAMINOPHEN/HYDROCODONE BITARTRATE
Tablets

   Hydrocodone Bitartrate
 and Acetaminophen   Halsey Drug   Halsey Drug

   Hydrocodone Bitartrate
 and Acetaminophen   Qualitest   Halsey Drug

   Hydrocodone Bitartrate
 and Acetaminophen   Pharmaceutical Basics   Pharmaceutical Basics

   Hydrocodone Bitartrate
 and Acetaminophen   Best Generics   Pharmaceutical Basics

   Hydrocodone Bitartrate
 and Acetaminophen   Barr Labs   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   Goldline Labs   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   Bioline Labs   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   Regal Labs   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   Genetco   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   J J Balan   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   H L Moore Drug Exchange   Barr Labs
ACETAMINOPHEN/HYDROCODONE BITARTRATE
Tablets—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Hydrocodone Bitartrate
 and Acetaminophen   Parmed Pharmaceuticals   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   Texas Drug Reps   Barr Labs

   Vapocet   Major Pharmaceutical Corp   Barr Labs

   Hydrocodone Bitartrate
 and Acetaminophen   LuChem Pharmaceuticals   LuChem Pharmaceuticals

   Hydrocodone Bitartrate
 and Acetaminophen   Watson Labs   Watson Labs

   Hycotab   Medicopharma   Charlotte Pharm.

   Hydrocodone Bitartrate
 and Acetaminophen   Martec Pharmaceutical   Charlotte Pharm.
ACETAMINOPHEN/OXYCODONE HCL
Capsules

   Oxycodone and Acetaminophen   Halsey Drug   Halsey Drug
ACETAMINOPHEN/OXYCODONE HCL
Tablets

   Oxycodone HCl/Acetaminophen   Barr Labs   Barr Labs

   Oxycodone HCl/Acetaminophen   Rugby Labs   Barr Labs

   Oxycodone HCl/Acetaminophen   Interstate Drug Exchange   Barr Labs

   Oxycodone HCl/Acetaminophen   Henry Schein   Barr Labs

   Oxycodone HCl/Acetaminophen   Roxane Labs   Roxane Labs

   Oxycet   Halsey Drug   Halsey Drug

   Acetaminophen/Oxycodone   Goldline Labs   Halsey Drug

   Acetaminophen/Oxycodone   Purepac Pharmaceutical   Halsey Drug

   Acetaminophen/Oxycodone   Interstate Drug Exchange   Halsey Drug

   Oxycodone HCl with APAP   Qualitest   Halsey Drug

   Apap and Oxycodone HCl   Goldline Labs   Barr Labs
ACETAMINOPHEN/PHENYLTOLOXAMINE CITRATE
Tablets

   Phenyltoloxamine-Apap   Richlyn Labs   Richlyn Labs

   Supergesic   Superpharm Corp   Superpharm Corp

   Biogesic   Bioline Labs   Superpharm Corp

   Phenylgesic   Amide Pharmaceutical   Amide Pharmaceutical

   Phenylgesic   Goldline Labs   Superpharm Corp
ACETAMINOPHEN/PROPOXYPHENE HCL
Tablets

   Propoxyphene HCl/Acetaminophen   Geneva Generics   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Bioline Labs   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Interstate Drug Exchange   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   H L Moore Drug Exchange   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Rugby Labs   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Henry Schein   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   United Research Labs   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Parmed Pharmaceuticals   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Purepac Pharmaceutical   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Mylan Pharmaceuticals   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Lemmon Co   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Goldline Labs   Mylan Pharmaceuticals

   Propoxyphene HCl/Acetaminophen   Qualitest   Mylan Pharmaceuticals

   Dolene - AP   Lederle Labs   Mylan Pharmaceuticals

   SK-65 APAP   Smith, Kline & French Labs   Mylan Pharmaceuticals

   Propoxyphene HCl w/APAP   Regal Labs   Mylan Pharmaceuticals

   Propoxyphene HCl w/APAP   Murray Drug   Mylan Pharmaceuticals

   Propoxyphene HCl w/APAP   Texas Drug Reps   Mylan Pharmaceuticals

   Propoxyphene HCl w/APAP   Towne, Paulsen   Mylan Pharmaceuticals

   Propoxyphene HCl w/APAP   Vita Rx   Mylan Pharmaceuticals

   Lorcet   UAD Labs   Mylan Pharmaceuticals

   Pancet   Pan American Labs   Mylan Pharmaceuticals

   Dolagesic   J M Dwyer   Mylan Pharmaceuticals

   Wygesic   Wyeth Labs   Wyeth Labs

   Propoxyphene HCl/
 Acetaminophen   Warner Chilcott Labs   Mylan Pharmaceuticals

   Propoxyphene HCl/
 Acetaminophen   Best Generics   Mylan Pharmaceuticals
ACETAMINOPHEN/PROPOXYPHENE NAPSYLATE
Tablets

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Propoxyphene Napsylate and
 Acetaminophen   Barr Labs   Barr Labs

   Propoxyphene Napsylate and
 Acetaminophen   Zenith Labs   Zenith Labs

   Propoxyphene Napsylate and
 Acetaminophen   Gen-King Products   Zenith Labs

   Propoxyphene Napsylate and
 Acetaminophen   Harber Pharmaceutical   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   Lemmon Co   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   Interstate Drug Exchange   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   Parmed Pharmaceuticals   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   Purepac Pharmaceutical   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   United Research Labs   Lemmon Co

   Propoxyphene Napsylate and
 Acetaminophen   Mylan Pharmaceuticals   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Goldline Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Henry Schein   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   H L Moore Drug Exchange   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Regal Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   United Research Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and  Acetaminophen   Bioline Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Rugby Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Purepac Pharmaceutical   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Parmed Pharmaceuticals   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Geneva Generics   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Qualitest   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Texas Drug Reps   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Glenlawn Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Genetco   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Warner Chilcott Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Schein Pharmaceutical   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Dixon-Shane   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Best Generics   Barr Labs

   Propoxyphene Napsylate and
 Acetaminophen   Rugby Labs   Chelsea Labs

   Propoxyphene Napsylate and
 Acetaminophen   Cord Labs   Cord Labs

   Propoxyphene Napsylate and
 Acetaminophen   Geneva Generics   Cord Labs

   Propoxyphene Napsylate and
 Acetaminophen   Superpharm Corp   Superpharm Corp

   Propoxyphene Napsylate and
 Acetaminophen   Best Generics   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Lederle Labs   Mylan Pharmaceuticals

   Propoxyphene Napsylate and
 Acetaminophen   Purepac Pharmaceutical   Purepac Pharmaceutical

   Propoxyphene Napsylate and
 Acetaminophen   Halsey Drug   Halsey Drug
ACETAZOLAMIDE
Tablets

   Acetazolamide   Bolar Pharmaceutical   Bolar Pharmaceutical

   Acetazolamide   Rugby Labs   Bolar Pharmaceutical
ACETAZOLAMIDE
Tablets—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Acetazolamide   Glenlawn Labs   Bolar Pharmaceutical

   Acetazolamide   Geneva Generics   Bolar Pharmaceutical

   Acetazolamide   Bell Pharmacal   Bolar Pharmaceutical

   Acetazolamide   Parmed Pharmaceutical   Bolar Pharmaceutical

   Acetazolamide   Qualitest   Bolar Pharmaceutical

   Acetazolamide   Purepac Pharmaceutical   Bolar Pharmaceutical

   Acetazolamide   United Research Labs   Bolar Pharmaceutical

   Acetazolamide   Best Generics   Bolar Pharmaceutical

   Acetazolamide   Mutual Pharmaceutical   Bolar Pharmaceutical

   Acetazolamide   Goldline Labs   Bolar Pharmaceutical

   Acetazolamide   Bioline Labs   Bolar Pharmaceutical

   Acetazolamide   Danbury Pharmacal   Danbury Pharmacal

   Acetazolamide   Lannett   Lannett

   Acetazolamide   Mutual Pharmaceutical   Mutual Pharmaceutical

   Acetazolamide   United Research Labs   Mutual Pharmaceutical

   Acetazolamide   Genetco   Mutual Pharmaceutical
ACETIC ACID - NONAQUEOUS
Otic Solution

   Acetic Acid   Thames Pharmacal   Thames Pharmacal

   Acetic Acid   Rugby Labs   National Pharmaceutical

   Acetasol   Qualitest   National Pharmaceutical

   Acetasol   Barre Drug   National Pharmaceutical

   Bio-Sol   Biocraft Labs   National Pharmaceutical

   Acetasol   Goldline Labs   Barre-National
ACETIC ACID - NONAQUEOUS/HYDROCORTISONE
Otic Solution

   Acetasol HC   Barre Drug   National Pharmaceutical

   Acetic Acid w/Hydro   Rugby Labs   National Pharmaceutical

   Bio-Sol HC   Bioline Labs   National Pharmaceutical

   Hydrocortisone/Acetic Acid   Thames Pharmacal   Thames Pharmacal

   Acetasol HC   Goldline Labs   Barre National
ACETOHEXAMIDE
Tablets

   Acetohexamide   Pharmaceutical Basics   Pharmaceutical Basics

   Acetohexamide   Best Generics   Pharmaceutical Basics

   Acetohexamide   Barr Labs   Barr Labs

   Acetohexamide   Danbury Pharmacal   Danbury Pharmacal
ALLANTOIN/AMINACRINE HCL/SULFANILAMIDE
Vaginal Cream

   Vaginal Sulfa Cream   G & W Labs   G & W Labs

   Vaginal Sulfa Cream   United Research Labs   Clay-Park Labs

   Vaginal Sulfa Cream   Interstate Drug Exchange   Clay-Park Labs

   Vaginal Sulfa Cream   Rugby Labs   Clay-Park Labs

   Vaginal Sulfa Cream   J J Balan   Clay-Park Labs

   Vaginal Sulfa Cream   Henry Schein   Clay-Park Labs

   Vaginal Sulfa Cream   Bioline Labs   Clay-Park Labs

   Vaginal Sulfa Cream   H L Moore Drug Exchange   Clay-Park Labs

   Vaginal Sulfa Cream   Cooper   Clay-Park Labs

   Vaginal Sulfa Cream   Goldline Labs   Clay-Park Labs

   Vaginal Sulfa Cream   Regal Labs   Clay-Park Labs

   Vaginal Sulfa Cream   Qualitest   Clay-Park Labs

   Vaginal Sulfa Cream   Clay-Park Labs   Clay-Park Labs

   Par Cream   Parmed Pharmaceuticals   Clay-Park Labs
ALLANTOIN/AMINACRINE HCL/SULFANILAMIDE
Vaginal Suppositories

   AAS   Rugby Labs   Pharmacaps

   CPB   Crown Drug   Pharmacaps

   Asulam   Cooper   Pharmacaps
ALLOPURINOL
Tablets

   Zyloprim   Burroughs Wellcome   Burroughs Wellcome

   Lopurin   Boots Labs   Boots Labs

   Allopurinol   Rugby Labs   Boots Labs

   Allopurinol   Goldline Labs   Boots Labs

   Allopurinol   Parmed Pharmaceuticals   Boots Labs

   Allopurinol   Geneva Generics   Boots Labs

   Allopurinol   Qualitest   Boots Labs

   Allopurinol   Purepac Pharmaceutical   Boots Labs
ALLOPURINOL
Tablets—Continued

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Allopurinol   United Research Labs   Boots Labs

   Allopurinol   Mutual Pharmaceutical   Boots Labs

   Allopurinol   Rugby Labs   Chelsea Labs

   Allopurinol   Danbury Pharmacal   Danbury Pharmacal

   Allopurinol   Qualitest   Danbury Pharmacal

   Allopurinol   Lederle Labs   Danbury Pharmacal

   Allopurinol   Geneva Generics   Danbury Pharmacal

   Allopurinol   Bolar Pharmaceutical   Bolar Pharmaceutical

   Allopurinol   United Research Labs   Bolar Pharmaceutical

   Allopurinol   Best Generics   Bolar Pharmaceutical

   Allopurinol   Purepac Pharmaceutical   Purepac Pharmaceutical

   Allopurinol   Par Pharmaceutical   Par Pharmaceutical

   Allopurinol   Mutual Pharmaceutical   Mutual Pharmaceutical

   Allopurinol   Schein Pharmaceutical   Danbury Pharmacal

   Allopurinol   Superpharm Corp   Superpharm Corp

   Allopurinol   Cord Labs   Cord Labs

   Allopurinol   Geneva Generics   Cord Labs

   Allopurinol   United Research Labs   Mutual Pharmaceutical

   Allopurinol   Bioline Labs   Mutual Pharmaceutical

   Allopurinol   Genetco   Mutual Pharmaceutical

   Allopurinol   Goldline Labs   Mutual Pharmaceutical

   Allopurinol   Barr Labs   Barr Labs

   Allopurinol   Mylan Pharmaceuticals   Mylan Pharmaceuticals

   Allopurinol   Dixon-Shane   Mutual Pharmaceutical

   Allopurinol   Bioline Labs   Mutual Pharmaceutical

   Allopurinol   Towne, Paulsen   Mutual Pharmaceutical

   Allopurinol   Purepac Pharmaceuticals   Mutual Pharmaceutical
ALUMINUM ACETATE
Topical Solution

   Aluminum Acetate   Halsey Drug   Halsey Drug
ALUMINUM HYDROXIDE
Suspension

   Aluminum Hydroxide Gel   Barre Drug   National Pharmaceutical

   Aluminum Hydroxide Gel   Rugby Labs   National Pharmaceutical

   Aluminum Hydroxide Gel   Goldline Labs   National Pharmaceutical

   Aluminum Hydroxide Gel   Henry Schein   National Pharmaceutical

   Aluminum Hydroxide Gel   Ascot   National Pharmaceutical

   Aluminum Hydroxide Gel   H L Moore Drug Exchange   National Pharmaceutical

   Aluminum Hydroxide Gel   Bioline Labs   National Pharmaceutical

   Aluminum Hydroxide Gel   Rugby Labs   Naska Pharmacal

   Aluminum Hydroxide Gel   Roxane Labs   Roxane Labs
ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE
Suspension

   Rolox   Purepac Pharmaceutical   Purepac Pharmaceutical

   Antacid   G & W Labs   G & W Labs

   Antacid   Rugby Labs   Naska Pharmacal

   Mag-Drox Antacid   Life Labs   Life Labs

   Kessadrox   McKesson Labs   MK Labs

   Liquid Antacid   McKesson Labs   MK Labs

   Alamag   Barre Drug   National Pharmaceutical

   Alamag   H L Moore Drug Exchange   National Pharmaceutical

   Alamag   Richie Pharmacal   National Pharmaceutical

   Alamag   United Research Labs   National Pharmaceutical

   Alamag   Medical Supplies   National Pharmaceutical

   Alamag   Glenlawn Labs   National Pharmaceutical

   Alamag   Murray Drug   National Pharmaceutical

   Alamag   Virginia Pharmaceutical   National Pharmaceutical

   M A H Liquid   Interstate Drug Exchange   National Pharmaceutical

   Mag-Gel   Syncon Pharmaceutical   National Pharmaceutical

   Magnagel   Mallard   National Pharmaceutical

   Genemag Gel   General Pharmaceutical   National Pharmaceutical

   Antacid   Cooper   National Pharmaceutical

   Antacid Suspension   Geneva Generics   National Pharmaceutical

   Aluminum/Magnesium Hydroxide Gel   Ascot   National Pharmaceutical
ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE/SIMETHICONE
Suspension

   Alma-Mag   Rugby Labs   Naska Pharmacal

   Newtrogel   Newtron Pharmaceuticals   Newtron Pharmaceuticals

   Mygel   Geneva Generics   Newtron Pharmaceuticals
ALUMINUM HYDROXIDE/MAGNESIUM TRISILICATE
Suspension

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Aluminum Hydroxide Gel w/
 Magnesium Trisilicate   Barre Drug   National Pharmaceutical

   Alma-Mag   Rugby Labs   National Pharmaceutical
AMANTADINE HCL
Capsules

   Amantadine HCl   Chase Labs   Chase Labs

   Amantadine HCl   Pharmaceutical Basics   Chase Labs

   Amantadine HCl   Martec Pharmaceutical   Chase Labs

   Amantadine HCl   Best Generics   Chase Labs

   Amantadine HCl   Lemmon Co   Chase Labs

   Amantadine HCl   Bolar Pharmaceutical   Pharmacaps
AMILORIDE HCL
Tablets

   Amiloride HCl   Par Pharmaceutical   Par Pharmaceutical

   Amiloride HCl   Qualitest   Par Pharmaceutical

   Amiloride HCl   Schein Pharmaceutical   Par Pharmaceutical

   Amiloride HCl   Goldline Labs   Par Pharmaceutical
AMILORIDE HCL/HYDROCHLOROTHIAZIDE
Tablets

   Amiloride HCl and
 Hydrochlorothiazide   Biocraft Labs   Biocraft Labs
AMINOPHYLLINE
Solution

   Aminophylline   Barre Drug   National Pharmaceutical

   Aminophylline   Henry Schein   National Pharmaceutical

   Aminophylline   Rugby Labs   National Pharmaceutical

   Aminophylline   United Research Labs   National Pharmaceutical

   Aminophylline   Roxane Labs   Roxane Labs

   Aminophylline DF   My-K Labs   My-K Labs

   Aminophylline DF   Pharmaceutical Basics   Pharmaceutical Basics
AMINOPHYLLINE
Tablets

   Aminophylline   Cord Labs   Cord Labs

   Aminophylline   Geneva Generics   Cord Labs

   Aminophylline   West-ward   West-ward

   Aminophylline   Towne, Paulsen   West-ward

   Aminophylline   Geneva Generics   West-ward

   Aminophylline   Euclid Pharmaceutical   West-ward

   Aminophylline   Henry Schein   West-ward

   Aminophylline   Regal Labs   West-ward

   Aminophylline   Bioline Labs   West-ward

   Aminophylline   Vangard Labs   West-ward

   Aminophylline   Rugby Labs   West-ward

   Aminophylline   United Research Labs   West-ward

   Aminophylline   Whiteworth Pharmaceuticals   West-ward

   Aminophylline   Bioline Labs   Duramed Pharmaceuticals

   Aminophylline   Major Pharmaceutical Corp   Duramed Pharmaceuticals

   Aminophylline   Penta Products   Duramed Pharmaceuticals

   Aminophylline   Regal Labs   Duramed Pharmaceuticals

   Aminophylline   Richie Pharmacal   Duramed Pharmaceuticals

   Aminophylline   Towne, Paulsen   Duramed Pharmaceuticals

   Aminophylline   UDL   Duramed Pharmaceuticals

   Aminophylline   Qualitest   Duramed Pharmaceuticals

   Aminophylline   Purepac Pharmaceutical   Duramed Pharmaceuticals

   Aminophylline   Duramed Pharmaceuticals   Duramed Pharmaceuticals

   Aminophylline   Goldline Labs   Duramed Pharmaceuticals
AMITRIPTYLINE HCL
Injection

   Elavil   Merck, Sharpe & Dohme   Merck, Sharpe & Dohme

   Amitriptyline HCl   Steris Labs   Steris Labs
AMITRIPTYLINE HCL
Tablets

   Brand Name/Generic Name   Distributed By:   Manufactured By:

   Elavil   Merck, Sharpe & Dohme   Merck, Sharpe & Dohme

   SK-Amitriptyline HCl   Smith, Kline & French Labs   Roxane Labs

   Amitriptyline HCl   Roxane Labs   Roxane Labs