[Title 21 CFR 1308.32]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1308 - SCHEDULES OF CONTROLLED SUBSTANCES]
[Sec. 1308.32 - Exempted prescription products.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  9
  1996-04-01
  1996-04-01
  false
  Exempted prescription products.
  1308.32
  Sec. 1308.32
  
    FOOD AND DRUGS
    DRUG ENFORCEMENT
    SCHEDULES OF CONTROLLED SUBSTANCES
  


Sec. 1308.32  Exempted prescription products.

    The following compounds, mixtures, or preparations which contain a 
non-narcotic controlled substance listed in Sec. 1308.12(e) or in 
Sec. 1308.13(b) or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in 
the Table of Exempted Prescription Products have been exempted by the 
Adminsitrator from the application of sections 302 through 305, 307 
through 309, 1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, 
and 952-954) and Secs. 1301.24, 1301.31, 1301.32, and Secs. 1301.71 
through 1301.76 of this chapter for administrative purposes only. Except 
that those products containing butalbital shall not be exempt from the 
requirements of 21 U.S.C. 952-954 concerning importation, exportation, 
transshipment and in-transit shipment of controlled substances. Any 
deviation from the quantitative composition of any of the listed drugs 
shall require a petition of exemption in order for the product to be 
exempted.

[[Page 177]]

                     Exempted Prescription Products

            Explanation of Column Headings and Abbreviations

    Company/Trade Name. Self explanatory.
    NDC Code. Refers to the specific National Drug Code listing for the 
particular formulated product.
    Form. Refers to the type of dosage formulation:
    CA=capsule
    DP=drops
    EL=elixir
    EC=enteric coated capsule
    ET=enteric coated tablet
    LQ=liquid
    SS=suspension
    SU=suppository
    TB=tablet
    WA=wafer
    XC=sustained release capsule
    XT=sustained release tablet
    Controlled Substance (mg or mg/ml). Refers to the type and amount of 
controlled substance present in the mixture. If the dosage formulation 
is solid (CA, EC, ET, SU, TB, WA, XC, or XT), the amount shown is 
milligrams per dosage unit. If the dosage formulation is liquid (DP, EL, 
LQ, or SS), the amount shown is milligrams per milliliter.

                                      Table of Exempt Prescription Products                                     
----------------------------------------------------------------------------------------------------------------
                                                                                         Controlled      (mg or 
            Company                  Trade Name           NDC Code          Form         Substance       mg/ml) 
----------------------------------------------------------------------------------------------------------------
Adria Laboratories.............  Axotal............         00013-1301  TB           Butalbital.......     50.00
Alpha Scriptics Inc............  Butacet Capsules..         53121-0133  CA           Butalbital.......     50.00
American Urologicals Inc.......  Butace............         00539-0906  CA           Butalbital.......     50.00
Apotheca.......................  Theophen..........         12634-0101  TB           Phenobarbital....      8.00
Arco Pharmaceuthcals...........  Arco-Lase Plus....         00275-0045  TB           Phenobarbital....      8.00
Arlo Interamerican.............  Espasmotex........         11475-0835  TB           Phenobarbital....     20.00
Ascher and Co..................  Anaspaz PB........         00225-0300  TB           Phenobarbital....     15.00
Ascot Pharmaceuticals..........  Antispasmodic              47679-0158  TB           Phenobarbital....     16.20
                                  Tablets.                                                                      
Ascot Pharmaceuticals..........  Chlordiazepoxide           47679-0268  CA           Chlordiazepoxide       5.00
                                  Hydrochloride +                                     HCl.                      
                                  Clidinium Bromide.                                                            
Ayerst Laboratories............  PMB-200...........         00046-0880  TB           Meprobamate......    200.00
Ayerst Laboratories............  PMB-400...........         00046-0881  TB           Meprobamate......    400.00
Barre Drug Co..................  Barophen..........         00472-0981  EL           Phenobarbital....      3.24
Barre Drug Co..................  Isolate Compound..         00472-0929  EL           Phenobarbital....      0.40
Baucum Laboratories Inc........  Butalbital,                54696-0513  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
Beecham Laboratories...........  Hybephen..........         00029-2360  TB           Phenobarbital....     15.00
Bioline Labs Inc...............  Anti-Spas Elixir..         00719-4090  EL           Phenobarbital....      3.24
Bioline Labs Inc...............  Anti-Spas Tablets.         00719-1091  TB           Phenobarbital....     16.20
Bioline Labs Inc...............  Bel-Phen-Ergot-S           00719-1686  TB           Phenobarbital....     40.00
                                  Tablets.                                                                      
Bioline Labs Inc...............  Chlordinium.......         00719-1208  CA           Chlordiazepoxide       5.00
                                                                                      HCl.                      
Blaine Co......................  Spaslin...........         00165-0029  TB           Phenobarbital....     16.20
Blansett Pharm Co..............  Anolor 300                 51674-0009  CA           Butalbital.......     50.00
                                  Capsules.                                                                     
Bock Pharmacal Co..............  Broncholate.......         00563-0277  CA           Phenobarbital....      8.00
Bowman Pharmaceutical..........  Private Formula No         00252-3095  TB           Phenobarbital         15.00
                                  3095.                                               Sodium.                   
Breon Labs.....................  Isuprel Compound..         00057-0874  EL           Phenobarbital....      0.40
Caldwell & Bloor Co............  Hyosital White....         00361-2131  TB           Phenobarbital....     16.20
Carnrick Labs Inc..............  Phrenilin.........         00086-0050  TB           Butalbital.......     50.00
Carnrick Labs Inc..............  Phrenilin Forte...         00086-0056  CA           Butalbital.......     50.00
Carpenter Pharmacal Co.........  ALAGESIC Tablets..         55726-0300  TB           Butalbital.......     50.00
Chelsea Laboratories...........  Chlordiazepoxide           46193-0948  CA           Chlordiazepoxide       5.00
                                  with Clidinium                                      HCl.                      
                                  Bromide.                                                                      
Columbia Drug Co...............  Isopap Capsules...         11735-0400  CA           Butalbital.......     50.00
Consolidated Midland...........  Bellalphen........         00223-0425  TB           Phenobarbital....     16.20
Dorasol Laboratories...........  Donalixir.........         00471-0095  EL           Phenobarbital....      3.24
Dunhall Pharmacal Inc..........  Triaprin..........         00217-2811  CA           Butalbital.......     50.00
Econolab.......................  Micomp-PB Tablets.         55053-0525  TB           Pentobarbital         30.00
                                                                                      Sodium.                   
Equipharm Corp.................  EQUI-CET Tablets..         57779-0111  TB           Butalbital.......     50.00
Everett Laboratories Inc.......  Repan Capsules....         00642-0163  CA           Butalbital.......     50.00
Everett Laboratories Inc.......  Repan Tablets.....         00642-0162  TB           Butalbital.......     50.00
Forest Pharmacal Inc...........  Acetaminophen 325          00456-0674  TB           Butalbital.......     50.00
                                  mg/Butalbital 50                                                              
                                  mg.                                                                           
Forest Pharmacal Inc...........  Acetaminophen 500          00456-0671  TB           Butalbital.......     50.00
                                  mg/Butalbital 50                                                              
                                  mg.                                                                           
Forest Pharmacal Inc...........  Bancap............         00456-0546  CA           Butalbital.......     50.00
Forest Pharmacal Inc...........  ESGIC-PLUS........         00456-0678  TB           Butalbital.......     50.00
Forest Pharmacal Inc...........  Esgic Capsules....         00456-0631  CA           Butalbital.......     50.00
Forest Pharmacal Inc...........  Esgic Tablets.....         00456-0630  TB           Butalbital.......     50.00
Forest Pharmacal Inc...........  G.B.S.............         00456-0281  TB           Phenobarbital....      8.00
Forest Pharmacal Inc...........  Soniphen..........         00456-0429  ET           Phenobarbital....     16.00
Gen-King Products..............  Antispasmodic.....         03547-0777  TB           Phenobarbital....     16.20
Genetco Inc....................  Butalbital,                00302-0490  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             

[[Page 178]]

                                                                                                                
Genetco Inc....................  Butalbital, Apap           00302-0490  TB           Butalbital.......     50.00
                                  and Caffeine.                                                                 
Geneva Generics................  Phenobarbital,             00781-1701  TB           Phenobarbital....     40.00
                                  Ergotamine and                                                                
                                  Belladonna                                                                    
                                  Tablets.                                                                      
Geriatric Pharmacal Corp.......  Bilezyme Plus.....         00249-1112  TB           Phenobarbital....      8.00
Geriatric Pharmacal Corp.......  Gustase Plus......         00249-1121  TB           Phenobarbital....      8.00
Glenlawn Laboratories..........  Chlordinium                00580-0084  CA           Chlordiazepoxide       5.00
                                  Sealets.                                            HCl.                      
Goldline Laboratories..........  Antispasmodic              00182-0686  EL           Phenobarbital....      3.24
                                  Elixir.                                                                       
Goldline Laboratories..........  Antispasmodic              00182-0129  TB           Phenobarbital....     16.20
                                  Tablets.                                                                      
Goldline Laboratories..........  Bel-phen-ergot s           00182-1847  TB           Phenobarbital....     40.00
                                  Tablets.                                                                      
Goldline Laboratories..........  Butalbital, APAP           00182-1274  TB           Butalbital.......     50.00
                                  and Caffeine                                                                  
                                  Tablets.                                                                      
Goldline Laboratories..........  C.D.P. Plus                00182-1856  CA           Chlordiazepoxide       5.00
                                  Capsules.                                           HCl.                      
H.L. Moore Drug Exchange.......  Antispasmodic              00839-5055  TB           Phenobarbital....     16.00
                                  Tablets.                                                                      
H.L. Moore Drug Exchange.......  Bellamor Tablets..         00839-7370  TB           Phenobarbital....     40.00
H.L. Moore Drug Exchange.......  Theophenyllin.....         00839-5111  TB           Phenobarbital....      8.00
Halsey Drug Co Inc.............  Blue Cross                 00879-0567  TB           Butalbital.......     50.00
                                  Butalbital, APAP                                                              
                                  and Caffeine                                                                  
                                  Tablets.                                                                      
Halsey Drug Co Inc.............  Butalbital and             00879-0543  TB           Butalbital.......     50.00
                                  Acetaminophen                                                                 
                                  Tablets.                                                                      
Halsey Drug Co Inc.............  Clinoxide.........         00879-0501  CA           Chlordiazepoxide       5.00
                                                                                      HCl.                      
Halsey Drug Co Inc.............  Susano............         00879-0059  EL           Phenobarbital....      3.24
Halsey Drug Co Inc.............  Susano............         00879-0058  TB           Phenobarbital....     16.20
Horizon Products Co............  Spastrin Tablets..         54580-0124  TB           Phenobarbital....     40.00
Hyrex Pharmaceutical...........  Panzyme...........         00314-0310  TB           Phenobarbital....      8.10
Hyrex Pharmaceutical...........  Two-Dyne Revised..         00314-2229  TB           Butalbital.......     50.00
Interstate Drug Exchange.......  IDE-Cet Tablets...         00814-3820  TB           Butalbital.......     50.00
Interstate Drug Exchange.......  Spastolate........         00814-7088  TB           Phenobarbital....     16.20
Intetlab.......................  CON-TEN...........         11584-1029  CA           Butalbital.......     50.00
Kaiser Foundation Hosp.........  Belladonna                 00179-0045  EL           Phenobarbital....      3.24
                                  Alkaloids with                                                                
                                  Phenobarbital.                                                                
Keene Pharmacal Inc............  Endolar...........         00588-7777  CA           Butalbital.......     50.00
Knoll Pharmaceutical...........  Quadrinal                  00044-4580  SS           Phenobarbital....      2.40
                                  Suspension.                                                                   
Knoll Pharmaceutical...........  Quadrinal Tablets.         00044-4520  TB           Phenobarbital....     24.00
Kraft Pharmacal Co Inc.........  Digestokraft......         00796-0237  TB           Butabarbital           8.00
                                                                                      Sodium.                   
Kremers Urban Co...............  Levsin with                00091-4530  EL           Phenobarbital....      3.00
                                  Phenobarbital                                                                 
                                  Elixir.                                                                       
Kremers Urban Co...............  Levsin with                00091-3534  TB           Phenobarbital....     15.00
                                  Phenobarbital                                                                 
                                  Tablets.                                                                      
Kremers Urban Co...............  Levsin-PB.........         00091-4536  DP           Phenobarbital....     15.00
Kremers Urban Co...............  Levsinex with              00091-3539  XC           Phenobarbital....     45.00
                                  Phenobarbital.                                                                
Landry Pharmacal Inc...........  Febridyne Plain            05383-0001  CA           Butalbital.......     50.00
                                  Capsules.                                                                     
Lanpar Co......................  PB Phe-Bell.......         12908-7006  TB           Phenobarbital....     16.20
Lasalle Laboratories...........  Pacaps Modified            48534-0884  CA           Butalbital.......     50.00
                                  Formula.                                                                      
Lemmon Pharmacal Co............  Donphen...........         00093-0205  TB           Phenobarbital....     15.00
Life Laboratories..............  Belladonna                 00737-1283  EL           Phenobarbital....      3.00
                                  Alkaloids with                                                                
                                  Phenobarbital.                                                                
Lunsco Inc.....................  Pacaps Capsules...         10892-0116  CA           Butalbital.......     50.00
Major Pharmacal Corp...........  Bellamine Tablets.         00904-2548  TB           Phenobarbital....     40.00
Major Pharmacal Corp...........  Cafatine-PB                00904-1750  TB           Pentobarbital         30.00
                                  Tablets.                                            Sodium.                   
Major Pharmacal Corp...........  Fabophen Tablets..         00904-3280  TB           Butalbital.......     50.00
Mallard Inc....................  Anoquan Modified           00166-0881  CA           Butalbital.......     50.00
                                  Formula.                                                                      
Mallard Inc....................  Malatal...........         00166-0748  TB           Phenobarbital....     16.20
Marlop Pharmacal Inc...........  Broncomar.........         12939-0128  EL           Butabarbital.....      1.00
Marlop Pharmacal Inc...........  Dolmar............         12939-0812  CA           Butalbital.......     50.00
Marnel Pharmacal Inc...........  Margesic Capsules.         00682-0804  CA           Butalbital.......     50.00
Martec Pharmacal Inc...........  Butalbital,                52555-0079  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
Mayrand Pharmacal Inc..........  B-A-C Tablets.....         00259-1256  TB           Butalbital.......     50.00
Mayrand Pharmacal Inc..........  Sedapap-10 Tablets         00259-1278  TB           Butalbital.......     50.00
Mead Johnson Pharmacal.........  Quibron Plus               00087-0518  CA           Butabarbital.....     20.00
                                  Capsules.                                                                     
Mead Johnson Pharmacal.........  Quibron Plus               00087-0511  EL           Butabarbital.....      1.33
                                  Elixir.                                                                       
Medco Supply Co................  Phenobarbital &            00764-2057  TB           Phenobarbital....     16.20
                                  Hyoscyamine                                                                   
                                  Sulfate.                                                                      

[[Page 179]]

                                                                                                                
Mikart Inc.....................  Butalbital and             46672-0099  TB           Butalbital.......     50.00
                                  Acetaminophen                                                                 
                                  Tablets 50/325.                                                               
Mikart Inc.....................  Butalbital and             46672-0098  TB           Butalbital.......     50.00
                                  Acetaminophen                                                                 
                                  Tablets 50/650.                                                               
Mikart Inc.....................  Butalbital,                46672-0228  CA           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Capsules.                                                            
Mikart Inc.....................  Butalbital,                46672-0053  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
Mikart Inc.....................  Butalbital,                46672-0059  TB           Butalbital.......     50.00
                                  Acetaminophen,                                                                
                                  and Caffeine                                                                  
                                  Tablets.                                                                      
Nejo Pharmaceutical............  Spasmalones.......         00653-0002  TB           Phenobarbital....     16.00
Parke-Davis & Co...............  Dilantin with              00071-0531  CA           Phenobarbital....     32.00
                                  Phenobarbital 1/2.                                                            
Parke-Davis & Co...............  Dilantin with              00071-0375  CA           Phenobarbital....     16.00
                                  Phenobarbital 1/4.                                                            
Parke-Davis & Co...............  Tedral SA.........         00071-0231  XT           Phenobarbital....     25.00
Parmed Pharmaceutical..........  Sedapar Elixir....         00349-4100  EL           Phenobarbital....      3.24
Parmed Pharmaceutical..........  Sedapar Tablets...         00349-2355  TB           Phenobarbital....     16.20
Pasadena Research..............  Seds..............         00418-4072  TB           Phenobarbital....     16.20
Pharmaceutical Basics Inc......  Antispasmodic              00832-8009  EL           Phenobarbital....      3.24
                                  Elixir.                                                                       
Pharmaceutical Basics Inc......  Butalbital,                00832-1102  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
Pharmaceutical Basics Inc......  Clinibrax Capsules         00832-1054  CA           Chlordiazepoxide       5.00
                                                                                      HCl.                      
Poythress & Co Inc.............  Antrocol..........         00095-0041  CA           Phenobarbital....     16.00
Poythress & Co Inc.............  Antrocol Elixir...         00095-0042  EL           Phenobarbital....      3.00
Poythress & Co Inc.............  Antrocol Tablets..         00095-0040  TB           Phenobarbital....     16.00
Poythress & Co Inc.............  Mudrane...........         00095-0050  TB           Phenobarbital....      8.00
Poythress & Co Inc.............  Mudrane GG Elixir.         00095-0053  EL           Phenobarbital....      0.50
Poythress & Co Inc.............  Mudrane GG Tablets         00095-0051  TB           Phenobarbital....      8.00
Private Formula Inc............  Sangesic..........         00511-1627  TB           Butalbital.......     30.00
Qualitest Products Inc.........  Butalbital,                52446-0544  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
Qualitest Products Inc.........  Chlordiazepoxide           52446-0096  CA           Chlordiazepoxide       5.00
                                  HCl 5 mg and                                        HCl.                      
                                  Clidinium Br 2.5                                                              
                                  mg.                                                                           
Redi-Med.......................  Butalbital                 53506-0103  CA           Butalbital.......     50.00
                                  Compound Capsules.                                                            
Rexar Pharmacal Corp...........  Rexatal Tablets...         00478-5477  TB           Phenobarbital....     16.52
Richlyn Laboratories...........  Aminophylline &            00115-2156  ET           Phenobarbital....     15.00
                                  Phenobarbital.                                                                
Richlyn Laboratories...........  Aminophylline &            00115-2154  TB           Phenobarbital....     15.00
                                  Phenobarbital                                                                 
                                  Tablets.                                                                      
Richlyn Laboratories...........  Bellophen.........         00115-2400  TB           Phenobarbital....     16.20
Richlyn Laboratories...........  Spasmolin.........         00115-4652  TB           Phenobarbital....     15.00
Robins A H Co Inc..............  Donnatal Capsules.         00031-4207  CA           Phenobarbital....     16.20
Robins A H Co Inc..............  Donnatal Elixir...         00031-4221  EL           Phenobarbital....      3.24
Robins A H Co Inc..............  Donnatal Extentabs         00031-4235  XT           Phenobarbital....     48.60
Robins A H Co Inc..............  Donnatal No 2.....         00031-4264  TB           Phenobarbital....     32.40
Robins A H Co Inc..............  Donnatal Tablets..         00031-4250  TB           Phenobarbital....     16.20
Robins A H Co Inc..............  Donnazyme.........         00031-4649  ET           Phenobarbital....      8.10
Roche Labs.....................  Librax............         00140-0007  CA           Chlordiazepoxide       5.00
                                                                                      HCl.                      
Roche Labs.....................  Menrium 10-4......         00140-0025  TB           Chlordiazepoxide.     10.00
Roche Labs.....................  Menrium 5-2.......         00140-0023  TB           Chlordiazepoxide.      5.00
Roche Labs.....................  Menrium 5-4.......         00140-0024  TB           Chlordiazepoxide.      5.00
Rondex Laboratories............  Antispasmodic.....         00367-4118  TB           Phenobarbital....     16.20
Rotex Pharmacal Inc............  Rogesic Capsules..         31190-0008  CA           Butalbital.......     50.00
Ruckstuhl Co...................  Sedarex No 3......         00144-1575  TB           Phenobarbital....     16.20
Rugby Laboratories Inc.........  Clindex...........         00536-3490  CA           Chlordiazepoxide       5.00
                                                                                      HCl.                      
Rugby Laboratories Inc.........  Ergocaff-PB                00536-3801  TB           Pentobarbital         30.00
                                  Tablets.                                            Sodium.                   
Rugby Laboratories Inc.........  Hyosophen Capsules         00536-3926  CA           Phenobarbital....     16.00
Rugby Laboratories Inc.........  Hyosophen Tablets.         00536-3920  TB           Phenobarbital....     16.20
Rugby Laboratories Inc.........  ISOCET Tablets....         00536-3951  TB           Butalbital.......     50.00
Rugby Laboratories Inc.........  Phenerbel-S                00536-4234  TB           Phenobarbital....     40.00
                                  Tablets.                                                                      
Rugby Laboratories Inc.........  Theodrine Tablets.         00536-4648  TB           Phenobarbital....      8.00
Russ Pharmacal Inc.............  FEMCET Capsules...         50474-0703  CA           Butalbital.......     50.00
Sandoz Pharmacal Corp..........  Belladenal........         00078-0028  TB           Phenobarbital....     50.00
Sandoz Pharmacal Corp..........  Belladenal-S......         00078-0027  XT           Phenobarbital....     50.00
Sandoz Pharmacal Corp..........  Bellergal-S.......         00078-0031  XT           Phenobarbital....     40.00
Sandoz Pharmacal Corp..........  Cafergot P-B               00078-0035  SU           Pentobarbital....     60.00
                                  Suppository.                                                                  

[[Page 180]]

                                                                                                                
Sandoz Pharmacal Corp..........  Cafergot P-B               00078-0036  TB           Pentobarbital         30.00
                                  Tablets.                                            Sodium.                   
Sandoz Pharmacal Corp..........  Fioricet..........         00078-0084  CA           Butalbital.......     50.00
Schein Henry Inc...............  Antispasmodic.....         00364-0020  TB           Phenobarbital....     16.00
Schein Henry Inc...............  Antispasmodic              00364-7002  EL           Phenobarbital....      3.20
                                  Elixir.                                                                       
Schein Henry Inc...............  Isolate Compound           00364-7029  EL           Phenobarbital....      0.40
                                  Elixir.                                                                       
Schein Henry Inc...............  T-E-P.............         00364-0266  TB           Phenobarbital....      8.10
Shoals Pharmacal Co............  Tencet............         47649-0370  TB           Butalbital.......     50.00
Shoals Pharmacal Co............  Tencet Capsules...         47649-0560  CA           Butalbital.......     50.00
Stewart-Jackson Pharmacal......  Ezol..............         45985-0578  CA           Butalbital.......     50.00
Stuart Pharmaceutical..........  Kinesed...........         00038-0220  TB           Phenobarbital....     16.00
Superpharm Laboratories........  Chlordiazepoxide           57247-1003  CA           Chlordiazepoxide       5.00
                                  HCl & Clidinium                                     HCl.                      
                                  Br.                                                                           
Towne Paulsen & Co.............  T. E. P...........         00157-0980  TB           Phenobarbital....      8.00
Trimen Labs....................  Amaphen Capsules           11311-0954  CA           Butalbital.......     50.00
                                  (reformulated).                                                               
Truxton C O Inc................  Atropine Sulfate           00463-6035  TB           Phenobarbital....     15.00
                                  with                                                                          
                                  Phenobarbital.                                                                
Truxton C O Inc................  Ephedrine with             00463-6086  TB           Phenobarbital....     15.00
                                  Phenobarbital.                                                                
Truxton C O Inc................  Spastemms Elixir..         00463-9023  EL           Phenobarbital....      3.24
Truxton C O Inc................  Spastemms Tablets.         00463-6181  TB           Phenobarbital....     15.00
U.S. Pharmaceuticals Inc.......  Medigesic Tablets.         52747-0311  TB           Butalbital.......     50.00
UAD Laboratories Inc...........  Bucet Capsules....         00785-2307  CA           Butalbital.......     50.00
UAD Laboratories Inc...........  Bucet Tablets.....         00785-2307  TB           Butalbital.......     50.00
UAD Laboratories Inc...........  Triad.............         00785-2306  TB           Butalbital.......     50.00
UAD Laboratories Inc...........  Triad Capsules....         00785-2305  CA           Butalbital.......     50.00
UDL Laboratories...............  Belladonna                 51079-0168  TB           Phenobarbital....     16.20
                                  Alkaloids with                                                                
                                  Phenobarbital.                                                                
United Research Labs Inc.......  Bel-Tabs..........         00677-1171  TB           Phenobarbital....     40.00
University of Iowa.............  Bladder Mixture            11326-1624  LQ           Phenobarbital....      2.92
                                  Plus                                                                          
                                  Phenobarbital.                                                                
Vale Chemical Co...............  Alkaloids of               00377-0527  TB           Phenobarbital....     16.20
                                  Belladonna and                                                                
                                  Phenobarbital.                                                                
Vale Chemical Co...............  Antispas..........         00377-0622  TB           Phenobarbital....     16.20
Vale Chemical Co...............  Barbeloid                  00377-0365  TB           Phenobarbital....     16.20
                                  (Revised) Green.                                                              
Vale Chemical Co...............  Barbeloid Yellow..         00377-0498  TB           Phenobarbital....     16.20
Vale Chemical Co...............  Charspast.........         00377-0500  TB           Phenobarbital....     16.20
Vale Chemical Co...............  Digestokraft......         00377-0460  TB           Butabarbital           8.00
                                                                                      Sodium.                   
Vale Chemical Co...............  Ephedrine & Sodium         00377-0109  TB           Phenobarbital         16.20
                                  Phenobarbital.                                      Sodium.                   
Vale Chemical Co...............  Panzyme...........         00377-0491  TB           Phenobarbital....      8.10
Vale Chemical Co...............  Pulsaphen.........         00377-0652  TB           Phenobarbital....     15.00
Vale Chemical Co...............  Truxaphen.........         00377-0541  TB           Phenobarbital....     16.20
Vale Chemical Co...............  Wescophen S-II....         00377-0628  TB           Phenobarbital....     30.00
Vale Chemical Co...............  Wesmatic Forte....         00377-0426  TB           Phenobarbital....      8.10
Vitarine Pharmacal Inc.........  E-Caff PB Tablets.         00185-0982  TB           Pentobarbital....     30.00
Vortech Pharmacal Co...........  Donna-Sed.........         00298-5054  EL           Phenobarbital....      3.24
Vortech Pharmacal Co...........  Hypnaldyne........         00298-1778  TB           Phenobarbital....     16.20
Vortech Pharmacal Co...........  Isophed...........         00298-5680  LQ           Phenobarbital....      0.40
Vortech Pharmacal Co...........  Phedral C. T......         00298-1173  TB           Phenobarbital....      8.10
W.E. Hauck Inc.................  G-1 Capsules......         43797-0244  CA           Butalbital.......     50.00
Wallace Laboratories...........  Barbidonna Elixir.         00037-0305  EL           Phenobarbital....      3.20
Wallace Laboratories...........  Barbidonna No 2...         00037-0311  TB           Phenobarbital....     32.00
Wallace Laboratories...........  Barbidonna Tablets         00037-0301  TB           Phenobarbital....     16.00
Wallace Laboratories...........  Butibel Elixir....         00037-0044  EL           Butabarbital           3.00
                                                                                      Sodium.                   
Wallace Laboratories...........  Butibel Tablets...         00037-0046  TB           Butabarbital          15.00
                                                                                      Sodium.                   
Wallace Laboratories...........  Lufyllin-EPG               00037-0565  EL           Phenobarbital....      1.60
                                  Elixir.                                                                       
Wallace Laboratories...........  Lufyllin-EPG               00037-0561  TB           Phenobarbital....     16.00
                                  Tablets.                                                                      
Wallace Laboratories...........  Milprem-200.......         00037-5501  TB           Meprobamate......    200.00
Wallace Laboratories...........  Milprem-400.......         00037-5401  TB           Meprobamate......    400.00
Wesley Pharmacal Co............  Hytrophen.........         00917-0244  TB           Phenobarbital....     16.20
Wesley Pharmacal Co............  Pulsaphen Gray....         00917-0113  TB           Phenobarbital....     15.00
Wesley Pharmacal Co............  Wescophen-S.......         00917-0135  TB           Phenobarbital....     30.00
Wesley Pharmacal Co............  Wesmatic Forte....         00917-0845  TB           Phenobarbital....      8.00
West-ward Inc..................  Belladonna                 00143-1140  TB           Phenobarbital....     16.20
                                  Alkaloids &                                                                   
                                  Phenobarbital.                                                                
West-ward Inc..................  Butalbital with            00143-1787  TB           Butalbital.......     50.00
                                  Acetaminophen and                                                             
                                  Caffeine Tablets.                                                             
West-ward Inc..................  Theophylline               00143-1695  TB           Phenobarbital....      8.00
                                  Ephedrine &                                                                   
                                  Phenobarbital.                                                                

[[Page 181]]

                                                                                                                
Winthrop Labs..................  Isuprel...........         00024-0874  EL           Phenobarbital....      0.40
Zenith Labs Inc................  Azpan.............         00172-3747  TB           Phenobarbital....      8.00
----------------------------------------------------------------------------------------------------------------

[52 FR 9803, Mar. 27, 1987, as amended at 53 FR 10861, April 1, 1988; 54 
FR 11520, Mar. 21, 1989; 55 FR 9114, Mar. 12, 1990; 57 FR 23301, June 3, 
1992]

                    Exempt Anabolic Steroid Products